ILUMIEN IV: OPTIMAL PCI
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03507777 |
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Recruitment Status :
Completed
First Posted : April 25, 2018
Last Update Posted : June 9, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease Coronary Stenosis Atherosclerosis STEMI STEMI - ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI | Device: Coronary PCI guided by OCT Device: Coronary PCI guided by Angiography | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2690 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI |
| Actual Study Start Date : | May 17, 2018 |
| Actual Primary Completion Date : | February 28, 2023 |
| Actual Study Completion Date : | February 28, 2023 |
| Arm | Intervention/treatment |
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Active Comparator: Coronary PCI guided by OCT
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. |
Device: Coronary PCI guided by OCT
Stent implantation in high-risk or complex lesions in patients with coronary artery disease using OCT guidance
Other Name: Optical Coherence Tomography |
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Active Comparator: Coronary PCI guided by Angiography
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. |
Device: Coronary PCI guided by Angiography
Stent implantation in high-risk or complex lesions in patients with coronary artery disease using angiography guidance |
- Imaging Outcome (Powered): Mean change in Minimal stent area (MSA), continuous measure [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Final post-PCI MSA (per target lesion basis) assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.
- Clinical outcome (Powered): Rate of Target vessel failure (TVF) [ Time Frame: At 2 years ]Time-to-first event rate of the composite outcome of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR), will be assessed.
- Rate of Target vessel failure (TVF) excluding periprocedural MI (Powered) [ Time Frame: At 2 years ]Time-to-first event rate of composite outcome of cardiac death, target vessel-related spontaneous myocardial infarction, or ischemia-driven target vessel revascularization (ID-TVR) will be assessed.
- Procedural Outcome (Non-Powered): Rate of Stent Expansion [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
MSA achieved in the proximal and distal stented segments relative to their respective reference lumen areas will be assessed. The stent length is divided into 2 equal segments (proximal and distal) except for lesions containing a bifurcation (visually estimated side branch ≥2.5 mm). When there is a bifurcation present, rather than splitting the stent into two halves, the division is based upon the midpoint of the proximal most side branch.
- Acceptable stent expansion (categorical variable): MSA of the proximal segment is ≥90% of the proximal reference lumen area and the MSA of the distal segment is ≥90% of the distal reference lumen area.
- Unacceptable stent expansion (categorical variable): MSA of the proximal segment is <90% of the proximal reference lumen area, and/or the MSA of the distal segment is <90% of the distal reference lumen area.
- Post-PCI stent expansion (%) (continuous variable): The MSA divided by the average of proximal and distal reference lumen areas x 100
- Procedural Outcome (Non-Powered): Rate of mean stent expansion (%) (continuous variable) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]The mean stent area (stent volume/analysed stent length) divided by the average of proximal and distal reference lumen areas x 100 will be assessed.
- Procedural Outcome (Non-Powered): Number of participants with Intra-stent plaque protrusion and thrombus [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
A mass attached to the luminal surface or floating within the lumen, meeting the following criteria will be assessed. Protrusion/thrombus is defined as any intraluminal mass protruding at least 0.2 mm within the luminal edge of a stent strut, and will be further classified as Major and Minor:
- Major: Protrusion area/Stent area at site of tissue protrusion ≥10% and the minimal intrastent flow area (MSA - protrusion area) is unacceptable (<90% of respective proximal or distal reference area
- Minor: Protrusion area/Stent area at site of tissue protrusion is <10%, or is ≥10% but the minimal intraluminal flow area (MSA - protrusion area) is acceptable (≥90% of respective proximal or distal reference area
- Procedural Outcome (Non-Powered): Number of participants with Untreated reference segment disease [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
Focal disease with untreated Mean Lumen Area (MLA) <4.5 mm^2 within 5 mm from the proximal and/or distal stent edges will be assessed.
Sub-classified by the amount of untreated lipid plaque, divided into 3 grades:
i. Low (≤90° of lipid arc)
ii. Medium (>90°-<180° of lipid arc)
iii. High (≥180° of lipid arc)
- Procedural Outcome (Non-Powered): Number of participants with Edge dissections [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
Edge dissections will be tabulated as:
A) Major (%): ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length
B) Minor (%): any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length
Edge dissections will be further classified as:
i. Intimal (limited to the intima layer, i.e. not extending beyond the internal elastic lamina)
ii. Medial (extending into the media layer)
iii. Adventitial (extending through the external elastic membrane/lamina)
- Procedural Outcome (Non-Powered): Number of participants with Stent Malapposition [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
Frequency (%) of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen border/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch) will be assessed.
Malapposition will be further classified as:
- Major: if associated with unacceptable stent expansion
- Minor: if associated with acceptable stent expansion
Stent Malapposition will be tabulated as:
i. Major (%)
ii. Minor (%)
iii. All (Major and Minor) (%)
- Procedural Outcome (Non-Powered): Number of participants with Border detection (angiography arm post-PCI only, blinded to investigator) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
The visibility of the vessel external elastic lamina (EEL) border by OCT will be evaluated at both reference sites (proximal and distal) and the MSA, after intervention and then classified into 3 grades:
- Good: ≥75% (270°) of visible circumference
- Moderate: ≥50% (180°) - <75% (270°) of visible circumference
- Poor: <50% (180°) of visible circumference
- Procedural Outcome (Non-Powered): Median Intra-stent lumen area (intra-stent flow area) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Intra-stent Lumen Area (Intra-stent Flow Area) is defined as stent area minus any protrusion
- Procedural Outcome (Non-Powered): Median effective lumen area (total flow area) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Intra-stent lumen area plus any area of malapposition between the stent and the vessel wall (lumen border/plaque border) will be assessed.
- Angiographic Endpoints (Non-Powered) - Final (post-PCI) Median minimal lumen diameter [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Minimum Lumen Diameter (MLD) will be assessed by the smallest measured luminal diameter in a diseased segment [as measured by Quantitative coronary angiography (QCA)].
- Angiographic Endpoints (Non-Powered) - Final (post-PCI) percent diameter stenosis [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Percent Diameter Stenosis will be calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
- Angiographic Endpoints (Non-Powered) - Median Acute lumen gain post-intervention [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Angiographic Endpoints will be assessed as Acute lumen gain post-intervention
- Angiographic Endpoints (Non-Powered) - Median Maximum Device Size (stent or post-dilatation balloon)/reference vessel diameter ratio [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
Angiographic Endpoints (QCA) will be assessed as Maximum device size/reference vessel diameter ratio.
Maximum device size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters.
Reference Vessel Diameter (RVD) refers to an average diameter of proximal and distal healthy segments by QCA. "Normal" reference segments are selected proximal and distal to the stenosis and averaged to define the reference vessel diameter.
- Angiographic Endpoints (Non-Powered) - Post-PCI target vessel Thrombolysis in Myocardial Infarction (TIMI) flow rate [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
TIMI Flow Grading System is defined as below:
- Grade 0 (no perfusion): There is no antegrade flow beyond the point of occlusion.
- Grade 1 (penetration without perfusion): The contrast material passes beyond the area of obstruction but "hangs up" and fails to opacify the entire coronary bed distal to the obstruction for the duration of the cineangiographic filming sequence.
- Grade 2 (partial perfusion): The contrast material passes across the obstruction and opacifies the coronary bed distal to the obstruction.
- Grade 3 (complete perfusion): Antegrade flow into the bed distal to the obstruction occurs as promptly as antegrade flow into the bed from the involved bed and is as rapid as clearance from an uninvolved bed in the same vessel or the opposite artery.
- Angiographic Endpoints (Non-Powered) - Angiographic complications - worst (anytime during the procedure) and final (post PCI and all imaging) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Angiographic complications - worst (anytime during the procedure) and final (post PCI and all imaging) - Angiographic dissection ≥ NHLBI type B, perforations (Ellis classification), intra-procedural thrombotic events (including slow-flow, no-reflow, side branch closure, distal embolization, and intra-procedural stent thrombosis, as per the standard angiographic core laboratory definitions will be assessed.
- Device Usage Endpoints (Non-Powered): Total stent length [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Site reported total stent length will be assessed per subject in millimeters from the distal to the proximal reference site using the OCT Lumen Profile software.
- Device Usage Endpoints (Non-Powered): Total number of stents [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Site reported total number of stents will be assessed per subject, in counts.
- Device Usage Endpoints (Non-Powered): Median Maximal stent size [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Site reported maximal stent size will be assessed per subject, in millimeters.
- Device Usage Endpoints (Non-Powered): Post dilatation [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Site reported post dilatation will be assessed per subjects.
- Device Usage Endpoints (Non-Powered): Total number of post-dilatation balloons [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Site reported total number of post-dilatation balloons will be assessed per subject in terms of use of balloon inflations.
- Device Usage Endpoints (Non-Powered): Maximal post-dilatation balloon size [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Site reported Maximal post-dilatation balloon size will be assessed per subject.
- Device Usage Endpoints (Non-Powered): Maximal device size [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Site reported Maximal device size (stent or post-dilatation balloon) will be assessed per subject, in millimeters.
- Device Usage Endpoints (Non-Powered): Median maximum inflation pressure [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Site reported Maximum inflation pressure (stent or post-dilatation balloon) will be assessed per subject, in atm.
- Additional Procedural endpoint (Non-Powered): Procedure time, fluoroscopy time, radiation exposure [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]First wire insertion to guide catheter removal, fluoroscopy time, and radiation exposure will be assessed.
- Additional Procedural endpoint (Non-Powered): Contrast use, contrast induced nephropathy and need for renal replacement therapy [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Contrast use; contrast induced nephropathy (defined as serum creatinine rise >25% or absolute increase >0.5 mg/dL); need for renal replacement therapy will be assessed.
- Additional Procedural endpoint (Non-Powered): Procedural success (must be present in all treated lesions and vessels) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
Procedural success is defined as:
A) angiographic core laboratory-assessed final (post-PCI) lesion angiographic diameter stenosis <30% and target vessel TIMI III flow without any of the angiographic complications listed in 16 above; plus B) the absence of site-assessed prolonged ST-segment elevation or depression (>30 minutes), cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, or procedural death
- Additional Procedural endpoint (Non-Powered): Procedural complications [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Procedural complications are defined as; A) angiographic core laboratory-assessed complications listed in 16 above occurring anytime during the procedure; or B) site-assessed prolonged ST-segment elevation or depression (>30 minutes), cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, or procedural death
- Additional Procedural endpoint (Non-Powered): OCT performance success (site reported) (OCT arm only) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Site reported OCT performance will be assessed both pre- and post-PCI procedure
- Additional Procedural endpoint (Non-Powered): OCT imaging-related procedural complications (CEC adjudicated) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Any procedural complications (e.g. angiographic dissection, perforation, thrombus, acute closure, etc.) requiring any active intervention (e.g. prolonged balloon inflations, additional stent implantation, pericardiocentesis, intubation, hemodynamic support or pressors, defibrillation or cardioversion) or death adjudicated by the CEC as definitely or likely attributable to the physical performance of OCT-imaging (e.g. passing the catheter through the vasculature or stent, or injecting contrast to clear the blood for imaging). For this definition, adverse events that arise due to changes in PCI strategy as the result of OCT findings are NOT considered OCT imaging-related procedural complications
- Additional Procedural endpoint (Non Powered): Number of Participants With Use of larger balloon [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Participants will be analyzed for the use of additional inventions used on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone.
- Additional Procedural endpoint (Non Powered): Number of Participants With Use of higher inflation pressures [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Participants will be analyzed for the use of additional inventions used on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone.
- Additional Procedural endpoint (Non Powered): Number of Participants With Use of additional inflations [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Participants will be analyzed for the use of additional inventions used on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone.
- Additional Procedural endpoint (Non Powered): Number of Participants With Use of additional stent(s) [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Participants will be analyzed for the use of additional inventions used on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone.
- Additional Procedural endpoint (Non Powered): Number of Participants With Thrombus aspiration [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Participants will be analyzed for the use of additional inventions used on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone.
- Additional Procedural endpoint (Non Powered): Number of Participants With Performance of atherectomy [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Participants will be analyzed for the use of additional inventions used on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone.
- Additional Procedural endpoint (Non Powered): Number of Participants With Other interventions [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]Participants will be analyzed for the use of additional inventions used on the basis of the pre-PCI or post-stent OCT-imaging run that would not have been performed based on angiographic guidance alone.
- Clinical outcomes (Non-Powered) - Number of Participants With Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: At 30 days ]Target Lesion Failure (TLF) is defined as the composite of cardiac death, target vessel related myocardial infarction, or ischemia-driven target lesion revascularization.
- Clinical outcomes (Non-Powered) - Number of Participants With Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: At 1 year ]Target Lesion Failure (TLF) is defined as the composite of cardiac death, target vessel related myocardial infarction, or ischemia-driven target lesion revascularization.
- Clinical outcomes (Non-Powered) - Number of Participants With Target lesion failure (TLF; cardiac death, TV-MI or ischemia-driven target lesion revascularization (ID-TLR) [ Time Frame: At 2 years ]Target Lesion Failure (TLF) is defined as the composite of cardiac death, target vessel related myocardial infarction, or ischemia-driven target lesion revascularization.
- Clinical outcomes (Non-Powered) - Number of Participants With All-cause mortality [ Time Frame: At 30 days ]
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death is defined as death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death is defined as any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Clinical outcomes (Non-Powered) - Number of Participants With All-cause mortality [ Time Frame: At 1 year ]
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death is defined as death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death is defined as any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Clinical outcomes (Non-Powered) - Number of Participants With All-cause mortality [ Time Frame: At 2 years ]
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death is defined as death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death is defined as any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Clinical outcomes (Non-Powered) - Number of Participants With Cardiac and Non-cardiac mortality [ Time Frame: At 30 days ]
Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death is defined as any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Clinical outcomes (Non-Powered) - Number of Participants With Cardiac and Non-cardiac mortality [ Time Frame: At 1 year ]
Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death is defined as any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Clinical outcomes (Non-Powered) - Number of Participants With Cardiac and Non-cardiac mortality [ Time Frame: At 2 years ]
Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death is defined as any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
- Clinical outcomes (Non-Powered) - Number of Participants With All Myocardial Infarction (MI) [ Time Frame: At 30 days ]
Periprocedural myocardial infarction occurring within 48 hours after all percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) procedures:
Absolute rise (from baseline to within 48 hours of procedure) in cardiac troponin of ≥35x the 99th percentile URL (or ≥35x ULN if URL is not available) or in the absence of cardiac troponin, rise in CK-MB to ≥ 5x the 99th percentile URL (or ≥5x ULN if URL is not available).
Spontaneous MI
All MIs which are not peri-procedural are considered spontaneous MIs. Spontaneous myocardial infarctions are usually related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection with resulting intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis.
- Clinical outcomes (Non-Powered) - Number of Participants With All myocardial infarction (MI) [ Time Frame: At 1 year ]
Periprocedural myocardial infarction occurring within 48 hours after all percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) procedures:
Absolute rise (from baseline to within 48 hours of procedure) in cardiac troponin of ≥35x the 99th percentile URL (or ≥35x ULN if URL is not available) or in the absence of cardiac troponin, rise in CK-MB to ≥ 5x the 99th percentile URL (or ≥5x ULN if URL is not available).
Spontaneous MI
All MIs which are not peri-procedural are considered spontaneous MIs. Spontaneous myocardial infarctions are usually related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection with resulting intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis.
- Clinical outcomes (Non-Powered) - Number of Participants With All myocardial infarction (MI) [ Time Frame: At 2 years ]
Periprocedural myocardial infarction occurring within 48 hours after all percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) procedures:
Absolute rise (from baseline to within 48 hours of procedure) in cardiac troponin of ≥35x the 99th percentile URL (or ≥35x ULN if URL is not available) or in the absence of cardiac troponin, rise in CK-MB to ≥ 5x the 99th percentile URL (or ≥5x ULN if URL is not available).
Spontaneous MI
All MIs which are not peri-procedural are considered spontaneous MIs. Spontaneous myocardial infarctions are usually related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection with resulting intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis.
- Clinical outcomes (Non-Powered) - Number of Participants With Target Vessel Myocardial Infarction (TV-MI) and non-TV-MI [ Time Frame: At 30 days ]
Target Vessel Myocardial Infarction (TV-MI) and non-TV-MI will be assessed.
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
- Clinical outcomes (Non-Powered) - Number of Participants With Target Vessel Myocardial Infarction (TV-MI) and non-TV-MI [ Time Frame: At 1 year ]
Target Vessel Myocardial Infarction (TV-MI) and non-TV-MI will be assessed.
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
- Clinical outcomes (Non-Powered) - Number of Participants With Target Vessel Myocardial Infarction (TV-MI) and non-TV-MI [ Time Frame: At 2 years ]
Target Vessel Myocardial Infarction (TV-MI) and non-TV-MI will be assessed.
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
- Clinical outcomes (Non-Powered) - Number of Participants With Periprocedural MI and non-periprocedural MI [ Time Frame: At 30 days ]
Periprocedural MI and non-periprocedural MI will be assessed.
Periprocedural myocardial infarction occurring within 48 hours after all percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) procedures:
Absolute rise (from baseline to within 48 hours of procedure) in cardiac troponin of ≥35x the 99th percentile URL (or ≥35x ULN if URL is not available) or in the absence of cardiac troponin, rise in CK-MB to ≥ 5x the 99th percentile URL (or ≥5x ULN if URL is not available).
- Clinical outcomes (Non-Powered) - Number of Participants With Periprocedural MI and non-periprocedural MI [ Time Frame: At 1 year ]
Periprocedural MI and non-periprocedural MI will be assessed.
Periprocedural myocardial infarction occurring within 48 hours after all percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) procedures:
Absolute rise (from baseline to within 48 hours of procedure) in cardiac troponin of ≥35x the 99th percentile URL (or ≥35x ULN if URL is not available) or in the absence of cardiac troponin, rise in CK-MB to ≥ 5x the 99th percentile URL (or ≥5x ULN if URL is not available).
- Clinical outcomes (Non-Powered) - Number of Participants With Periprocedural MI and non-periprocedural MI [ Time Frame: At 2 years ]
Periprocedural MI and non-periprocedural MI will be assessed.
Periprocedural myocardial infarction occurring within 48 hours after all percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) procedures:
Absolute rise (from baseline to within 48 hours of procedure) in cardiac troponin of ≥35x the 99th percentile URL (or ≥35x ULN if URL is not available) or in the absence of cardiac troponin, rise in CK-MB to ≥ 5x the 99th percentile URL (or ≥5x ULN if URL is not available).
- Clinical outcomes (Non-Powered) - Number of Participants With All revascularization [ Time Frame: At 30 days ]All revascularization (comprised of TLR, TVR excluding TLR, and non-TVR) will be assessed
- Clinical outcomes (Non-Powered) - Number of Participants With All revascularization [ Time Frame: At 1 year ]All revascularization (comprised of TLR, TVR excluding TLR, and non-TVR) will be assessed
- Clinical outcomes (Non-Powered) - Number of Participants With All revascularization [ Time Frame: At 2 years ]All revascularization (comprised of TLR, TVR excluding TLR, and non-TVR) will be assessed
- Clinical outcomes (Non-Powered) - Number of Participants With ID-revascularization and non-ID-revascularization [ Time Frame: At 30 days ]
ID-revascularization and non-ID-revascularization will be assessed.
A revascularization is considered ischemia driven if associated with any of the following:
- Positive functional ischemia study including positive FFR, iFR, etc.
- Ischemic symptoms and angiographic diameter stenosis ≥50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
- Clinical outcomes (Non-Powered) - Number of Participants With ID-revascularization and non-ID-revascularization [ Time Frame: At 1 year ]
ID-revascularization and non-ID-revascularization will be assessed.
A revascularization is considered ischemia driven if associated with any of the following:
- Positive functional ischemia study including positive FFR, iFR, etc.
- Ischemic symptoms and angiographic diameter stenosis ≥50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
- Clinical outcomes (Non-Powered) - Number of Participants With ID-revascularization and non-ID-revascularization [ Time Frame: At 2 years ]
ID-revascularization and non-ID-revascularization will be assessed.
A revascularization is considered ischemia driven if associated with any of the following:
- Positive functional ischemia study including positive FFR, iFR, etc.
- Ischemic symptoms and angiographic diameter stenosis ≥50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
- Clinical outcomes (Non-Powered) - Number of Participants With ID-TVR, ID-TLR, ID-non-TLR TVR, and ID-non-TVR [ Time Frame: At 30 days ]
ID-TVR, ID-TLR, ID-non-TLR TVR, and ID-non-TVR will be assessed.
Ischemia-Driven [ID] Revascularization (TLR/TVR): A revascularization is considered ischemia driven if associated with any of the following:
- Positive functional ischemia study including positive FFR, iFR, etc.
- Ischemic symptoms and angiographic diameter stenosis ≥50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
- Clinical outcomes (Non-Powered) - Number of Participants With ID-TVR, ID-TLR, ID-non-TLR TVR, and ID-non-TVR [ Time Frame: At 1 year ]
ID-TVR, ID-TLR, ID-non-TLR TVR, and ID-non-TVR will be assessed.
Ischemia-Driven [ID] Revascularization (TLR/TVR): A revascularization is considered ischemia driven if associated with any of the following:
- Positive functional ischemia study including positive FFR, iFR, etc.
- Ischemic symptoms and angiographic diameter stenosis ≥50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
- Clinical outcomes (Non-Powered) -Number of Participants With ID-TVR, ID-TLR, ID-non-TLR TVR, and ID-non-TVR [ Time Frame: At 2 years ]
ID-TVR, ID-TLR, ID-non-TLR TVR, and ID-non-TVR will be assessed.
Ischemia-Driven [ID] Revascularization (TLR/TVR): A revascularization is considered ischemia driven if associated with any of the following:
- Positive functional ischemia study including positive FFR, iFR, etc.
- Ischemic symptoms and angiographic diameter stenosis ≥50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
- Clinical outcomes (Non-Powered) - Number of Participants With Definite, probable and definite/probable stent thrombosis (ARC 2 definition) [ Time Frame: At 30 days ]
Definite, probable and definite/probable stent thrombosis (ARC 2 definition) will be assessed.
Stent Thrombosis, Definite: Definite stent thrombosis is considered to have occurred by either angiographic or pathological confirmation.
Stent Thrombosis, Probable: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
- Any unexplained death within the first 30 days.
- Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
- Clinical outcomes (Non-Powered) - Number of Participants With Definite, probable and definite/probable stent thrombosis (ARC 2 definition) [ Time Frame: At 1 year ]
Definite, probable and definite/probable stent thrombosis (ARC 2 definition) will be assessed.
Stent Thrombosis, Definite: Definite stent thrombosis is considered to have occurred by either angiographic or pathological confirmation.
Stent Thrombosis, Probable: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
- Any unexplained death within the first 30 days.
- Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
- Clinical outcomes (Non-Powered) - Number of Participants With Definite, probable and definite/probable stent thrombosis (ARC 2 definition) [ Time Frame: At 2 years ]
Definite, probable and definite/probable stent thrombosis (ARC 2 definition) will be assessed.
Stent Thrombosis, Definite: Definite stent thrombosis is considered to have occurred by either angiographic or pathological confirmation.
Stent Thrombosis, Probable: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
- Any unexplained death within the first 30 days.
- Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
- Clinical outcomes (Non-Powered) - Relationship between immediate post-procedure OCT parameters and 30 days endpoint rates [ Time Frame: At 30 days ]Relationship between immediate post-procedure OCT parameters (e.g. MSA, procedural success, malapposition, dissection, protrusion, etc.) and 30 days endpoint rates (e.g. Target Vessel Failure (TVF), Target Lesion Failure (TLF), all-cause mortality, cardiac death, TV-MI, all MI, ID-TLR, ID-TVR, and stent thrombosis) will be assessed
- Clinical outcomes (Non-Powered) - Relationship between immediate post-procedure OCT parameters and 1-year endpoint rates [ Time Frame: At 1 year ]Relationship between immediate post-procedure OCT parameters (e.g. MSA, procedural success, malapposition, dissection, protrusion, etc.) and 1-year endpoint rates (e.g. Target Vessel Failure (TVF), Target Lesion Failure (TLF), all-cause mortality, cardiac death, TV-MI, all MI, ID-TLR, ID-TVR, and stent thrombosis) will be assessed
- Clinical outcomes (Non-Powered) - Relationship between immediate post-procedure OCT parameters and 2-year endpoint rates [ Time Frame: At 2 years ]Relationship between immediate post-procedure OCT parameters (e.g. MSA, procedural success, malapposition, dissection, protrusion, etc.) and 2-year endpoint rates (e.g. Target Vessel Failure (TVF), Target Lesion Failure (TLF), all-cause mortality, cardiac death, TV-MI, all MI, ID-TLR, ID-TVR, and stent thrombosis) will be assessed
- Clinical outcomes (Non-Powered): Rate of Target vessel failure (TVF) excluding periprocedural MI [ Time Frame: At 30 days ]The composite outcome of cardiac death, target vessel-related spontaneous myocardial infarction, or ischemia-driven target vessel revascularization (ID-TVR) will be assessed.
- Clinical outcomes (Non-Powered): Rate of Target vessel failure (TVF) excluding periprocedural MI [ Time Frame: At 1 year ]The composite outcome of cardiac death, target vessel-related spontaneous myocardial infarction, or ischemia-driven target vessel revascularization (ID-TVR) will be assessed.
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with TV-MI [periprocedural MI by Society for Cardiovascular Angiography and Interventions (SCAI) definition and spontaneous MI by protocol definition) [ Time Frame: At 30 days ]
As a sensitivity analysis, periprocedural MI will also be adjudicated and reported according to the SCAI Definition:
- In patients with normal baseline CK-MB
- In patients with elevated baseline CK-MB (or cTn) in whom the biomarker levels are stable or falling
- In patients with elevated CK-MB (or cTn) in whom the biomarker levels have not been shown to be stable or falling
Spontaneous MI
All MIs which are not peri-procedural are considered spontaneous MIs. Spontaneous myocardial infarctions are usually related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection with resulting intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis.
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with TV-MI [periprocedural MI by Society for Cardiovascular Angiography and Interventions (SCAI) definition and spontaneous MI by protocol definition) [ Time Frame: At 1 year ]
As a sensitivity analysis, periprocedural MI will also be adjudicated and reported according to the SCAI Definition:
- In patients with normal baseline CK-MB
- In patients with elevated baseline CK-MB (or cTn) in whom the biomarker levels are stable or falling
- In patients with elevated CK-MB (or cTn) in whom the biomarker levels have not been shown to be stable or falling
Spontaneous MI
All MIs which are not peri-procedural are considered spontaneous MIs. Spontaneous myocardial infarctions are usually related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection with resulting intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis.
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with TV-MI [periprocedural MI by Society for Cardiovascular Angiography and Interventions (SCAI) definition and spontaneous MI by protocol definition) [ Time Frame: At 2 years ]
As a sensitivity analysis, periprocedural MI will also be adjudicated and reported according to the SCAI Definition:
- In patients with normal baseline CK-MB
- In patients with elevated baseline CK-MB (or cTn) in whom the biomarker levels are stable or falling
- In patients with elevated CK-MB (or cTn) in whom the biomarker levels have not been shown to be stable or falling
Spontaneous MI
All MIs which are not peri-procedural are considered spontaneous MIs. Spontaneous myocardial infarctions are usually related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection with resulting intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis.
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with Periprocedural MI (by SCAI definition) [ Time Frame: At 30 days ]
As a sensitivity analysis, periprocedural MI will also be adjudicated and reported according to the SCAI Definition:
- In patients with normal baseline CK-MB
- In patients with elevated baseline CK-MB (or cTn) in whom the biomarker levels are stable or falling
- In patients with elevated CK-MB (or cTn) in whom the biomarker levels have not been shown to be stable or falling
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with Periprocedural MI (by SCAI definition) [ Time Frame: At 1 year ]
As a sensitivity analysis, periprocedural MI will also be adjudicated and reported according to the SCAI Definition:
- In patients with normal baseline CK-MB
- In patients with elevated baseline CK-MB (or cTn) in whom the biomarker levels are stable or falling
- In patients with elevated CK-MB (or cTn) in whom the biomarker levels have not been shown to be stable or falling
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with Periprocedural MI (by SCAI definition) [ Time Frame: At 2 years ]
As a sensitivity analysis, periprocedural MI will also be adjudicated and reported according to the SCAI Definition:
- In patients with normal baseline CK-MB
- In patients with elevated baseline CK-MB (or cTn) in whom the biomarker levels are stable or falling
- In patients with elevated CK-MB (or cTn) in whom the biomarker levels have not been shown to be stable or falling
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with All MI (periprocedural MI by SCAI definition and spontaneous MI by protocol definition) [ Time Frame: At 30 days ]
As a sensitivity analysis, periprocedural MI will also be adjudicated and reported according to the SCAI Definition:
- In patients with normal baseline CK-MB
- In patients with elevated baseline CK-MB (or cTn) in whom the biomarker levels are stable or falling
- In patients with elevated CK-MB (or cTn) in whom the biomarker levels have not been shown to be stable or falling
Spontaneous MI
All MIs which are not peri-procedural are considered spontaneous MIs. Spontaneous myocardial infarctions are usually related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection with resulting intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis.
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with All MI (periprocedural MI by SCAI definition and spontaneous MI by protocol definition) [ Time Frame: At 1 year ]
As a sensitivity analysis, periprocedural MI will also be adjudicated and reported according to the SCAI Definition:
- In patients with normal baseline CK-MB
- In patients with elevated baseline CK-MB (or cTn) in whom the biomarker levels are stable or falling
- In patients with elevated CK-MB (or cTn) in whom the biomarker levels have not been shown to be stable or falling
Spontaneous MI
All MIs which are not peri-procedural are considered spontaneous MIs. Spontaneous myocardial infarctions are usually related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection with resulting intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis.
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with All MI (periprocedural MI by SCAI definition and spontaneous MI by protocol definition) [ Time Frame: At 2 years ]
As a sensitivity analysis, periprocedural MI will also be adjudicated and reported according to the SCAI Definition:
- In patients with normal baseline CK-MB
- In patients with elevated baseline CK-MB (or cTn) in whom the biomarker levels are stable or falling
- In patients with elevated CK-MB (or cTn) in whom the biomarker levels have not been shown to be stable or falling
Spontaneous MI
All MIs which are not peri-procedural are considered spontaneous MIs. Spontaneous myocardial infarctions are usually related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection with resulting intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis.
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with Target Vessel Failure (TVF) [ Time Frame: At 30 days ]Target Vessel Failure (TVF) is defined as the composite of cardiac death, target vessel related myocardial infarction TV-MI (SCAI), or ischemia driven target vessel revascularization (ID-TVR).
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with Target Vessel Failure (TVF) [ Time Frame: At 1 year ]Target Vessel Failure (TVF) is defined as the composite of cardiac death, target vessel related myocardial infarction TV-MI (SCAI), or ischemia driven target vessel revascularization (ID-TVR).
- Clinical outcomes (Non-Powered): Sensitivity analyses: Number of participants with Target Vessel Failure (TVF) [ Time Frame: At 2 years ]Target Vessel Failure (TVF) is defined as the composite of cardiac death, target vessel related myocardial infarction TV-MI (SCAI), or ischemia driven target vessel revascularization (ID-TVR).
- Patient Reported Outcomes (PRO) (Non-Powered): EuroQoL 5D (EQ-5D-5L) survey [ Time Frame: At 30 days ]
Patient Reported Outcome questionnaires will provide a complementary evaluation of the effectiveness of OCT-guided stent implantation.
The EuroQoL 5D (EQ-5D-5L) survey will be used to assess overall health status.
- Patient Reported Outcomes (PRO) (Non-Powered): EuroQoL 5D (EQ-5D-5L) survey [ Time Frame: At 1 year ]
Patient Reported Outcome questionnaires will provide a complementary evaluation of the effectiveness of OCT-guided stent implantation.
The EuroQoL 5D (EQ-5D-5L) survey will be used to assess overall health status.
- Patient Reported Outcomes (PRO) (Non-Powered): EuroQoL 5D (EQ-5D-5L) survey [ Time Frame: At 2 years ]
Patient Reported Outcome questionnaires will provide a complementary evaluation of the effectiveness of OCT-guided stent implantation.
The EuroQoL 5D (EQ-5D-5L) survey will be used to assess overall health status.
- Cost-effectiveness (Non-Powered): Quality Adjusted Life Year (QALY) [ Time Frame: At 2 years ]Cost per QALY and TVF event prevented by OCT-guidance to be determined using standardized methods.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria (all must be present)
- Subject must be at least 18 years of age.
- Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective PCI.
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Patients undergoing planned XIENCE stent implantation during a clinically indicated PCI procedure meeting one or more of the following criteria:
A) High clinical-risk, defined as;
i. Medication-treated diabetes mellitus, AND/OR
B) High angiographic-risk lesion(s), with at least one target lesion in each target vessel planned for randomization meeting at least one of the following criteria;
i. Target lesion is the culprit lesion responsible for either:
- NSTEMI, defined as a clinical syndrome consistent with an acute coronary syndrome and a minimum troponin of 1 ng/dL (may or may not have returned to normal), OR
- STEMI >24 hours from the onset of ischemic symptoms
ii. long or multiple lesions (defined as intended total stent length in any single target vessel ≥28 mm),
Note: For a long target lesion, this would permit treatment by a single long stent or overlapping stents.
Note: For up to two target lesions located in a single target vessel and treated with non-overlapping stents, they may be located in a continuous vessel or split up between a main vessel and a side branch.
iii. bifurcation intended to be treated with 2 planned stents (i.e. in both the main branch and side branch), and where the planned side branch stent is ≥ 2.5 mm in diameter by angiographic visual estimation.
iv. angiographic severe calcification (defined as angiographically visible calcification on both sides of the vessel wall in the absence of cardiac motion),
v. chronic total occlusion (CTO) (enrolment and randomization in this case performed only after successful antegrade wire escalation crossing and pre-dilatation)
vi. in-stent restenosis of diffuse or multi-focal pattern. Lesion must be at or within the existing stent margin(s) and have angiographically visually-assessed DS ≥70% or DS ≥50% with non-invasive or invasive evidence of ischemia
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All target lesions (those lesions to be randomized) must have a visually estimated or quantitatively assessed %DS of either ≥70%, or ≥50% plus one or more of the following: an abnormal functional test (e.g. fractional flow reserve, stress test) signifying ischemia in the distribution of the target lesion(s) or biomarker positive ACS with plaque disruption or thrombus.
Note: For purposes of study eligibility, a minimum troponin of 1 ng/dL at the time of screening will be considered biomarker positive.
- All target lesions must be planned for treatment with only ≥2.5 mm and ≤3.5 mm stents and post-dilatation balloons based on pre-PCI angiographic visual estimation.
-
No more than 2 target lesions requiring PCI are present in any single vessel., and no more than 2 target vessels are allowed. Thus, up to 4 randomized target lesions per patient in a maximum of 2 target vessels are allowed, including branches. The intended target lesions will be declared just prior to randomization.
Note: A lesion is defined as any segment(s) of the coronary tree, no matter how long, which is planned to be covered with one contiguous length of stent, whether single or overlapped. A bifurcation counts as a single lesion even if the side branch is planned to be treated.
Note: All lesions in a randomized target vessel that are intended to be treated by PCI are designated as target lesions, and at least one target lesion in each randomized target vessel must meet angiographic high-risk inclusion criteria summarized above in 3B). The only exception is for patients who qualify for the trial on the basis of medication-treated diabetes, in which case no target lesion is required to meet angiographic high-risk inclusion criteria.
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All target lesions intended to be treated by PCI in the target vessel are amenable to OCT-guided PCI.
Example: If a qualifying angiographic high-risk lesion is in the proximal LAD, and there is a second target lesion in the distal LAD which is a focal lesion not otherwise meeting high-risk criteria, both the proximal LAD and distal LAD lesions must be amenable to OCT (e.g. no excessive tortuosity or calcification precluding delivering the OCT catheter), and each lesion must undergo OCT-guided stenting. Otherwise the vessel should be excluded from randomization.
- Subject must provide written Informed Consent prior to any study related procedure.
Exclusion Criteria (none may be present)
Clinical exclusion criteria:
- STEMI ≤24 hours from the onset of ischemic symptoms
- Creatinine clearance ≤30 ml/min/1.73 m^2 (as calculated by MDRD formula for estimated GFR) and not on dialysis. Note: chronic dialysis dependent patients are eligible for enrolment regardless of creatinine clearance.
- Hypotension, shock or need for mechanical support or intravenous vasopressors at the time the patient would be undergoing the index procedure.
- CHF (Killip class ≥2 or NYHA class ≥3)
- LVEF ≤30% by the most recent imaging test within 3 months prior to procedure. If no LVEF test result within 3 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method.
- Unstable ventricular arrhythmias
- Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least 6 months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which case a shorter duration of DAPT may be prescribed per local standard of care.
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Planned major cardiac or non-cardiac surgery within 24 months after the index procedure.
Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered.
Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
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Prior PCI within the target vessel within 12 months
Note: Prior PCI within the target vessel within 12 months is allowed for in-stent restenosis (target lesion is the prior PCI site) if no more than one layer of previously implanted stent is present.
Note: In-stent restenosis involving two or more layers of stent implanted at any time prior to index procedure (i.e. an earlier episode of in-stent restenosis previously treated with a second stent) is excluded.
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Any planned PCI within the target vessel(s) within 24 months after the study procedure, other than a planned staged intervention in a second randomized target vessel.
Note: Planned staged interventions must be noted at the time of randomization, and the decision to stage may be modified within 24 hours of completion of the index PCI.
Note: PCI in non-target vessels is permitted >48 hours after the index procedure.
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Any prior PCI in a non-target vessel within 24 hours before the study procedure, or within previous 30 days if unsuccessful or complicated.
Note: Patients requiring non-target vessel PCI may be enrolled and the non-target vessel(s) may be treated in the same index procedure as the randomized lesions (in all cases prior to randomization), as long as treatment of the lesion(s) in the non-target vessel is successful and uncomplicated.
Successful and uncomplicated definition for non-target vessel treatment during the index procedure: Angiographic diameter stenosis <10% for all treated non-target lesions, with TIMI III flow in this vessel, without final dissection ≥ NHLBI type B, perforation anytime during the procedure, prolonged chest pain (>5 minutes) or prolonged ST-segment elevation or depression (>5 minutes), or cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation).
- Subject has known hypersensitivity or contraindication to any of the study drugs (including all P2Y12 inhibitors, one or more components of the study devices, including everolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoropolymers, or radiocontrast dye) that cannot be adequately pre-medicated.
- Subject has received a solid organ transplant which is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
- Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
- Subject has a platelet count <100,000 cells/mm^3 or >700,000 cells/mm^3.
- Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- Subject has a history of bleeding diathesis or coagulopathy, or has had a significant gastro-intestinal or significant urinary bleed within the past six months.
- Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).
- Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
- Subject has life expectancy <2 years for any non-cardiac cause.
- Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Angiographic exclusion criteria
- Syntax score ≥33, unless a formal meeting of the Heart Team, including a cardiac surgeon, concludes that PCI is appropriate.
- Planned use of any stent <2.5 mm in a target vessel based on visual estimation (note: a smaller stent may be used in a bail-out scenario - e.g. to treat a distal dissection - but its use cannot be planned prior to enrolment)
- Planned use of a stent or post-dilatation balloon ≥3.75 mm for the target lesion
- Severe vessel tortuosity or calcification in a target vessel such that it is unlikely that the OCT catheter can be delivered (note: severe vessel calcification is allowed if it is expected that the OCT catheter can be delivered at baseline or after vessel preparation with balloon pre-dilatation or atherectomy)
- The target vessel has a lesion with DS ≥ 50% that is not planned for treatment at the time of index procedure.
- The target lesion is in the left main coronary artery
- The target lesion is in a bypass graft conduit. Note: A native coronary artery may be randomized if a prior bypass graft conduit to the vessel is totally occluded, but not if it is patent.
- The target lesion is an ostial RCA stenosis
- The target lesion is a stent thrombosis
- Planned use of any stent other than Xience in a target lesion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507777
Show 90 study locations
| Study Chair: | Gregg W Stone, MD | Icahn School of Medicine at Mount Sinai | |
| Principal Investigator: | Ulf Landmesser, MD | Charite University, Berlin, Germany | |
| Principal Investigator: | Ziad A Ali, MD, DPhil | St Francis Hospital and Heart Center |
| Responsible Party: | Abbott Medical Devices |
| ClinicalTrials.gov Identifier: | NCT03507777 |
| Other Study ID Numbers: |
ABT-CIP-10233 SJM-CIP-10218 ( Other Identifier: Abbott Laboratories ) |
| First Posted: | April 25, 2018 Key Record Dates |
| Last Update Posted: | June 9, 2023 |
| Last Verified: | June 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
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ABT-CIP-10233 ILUMIEN OPTIS OCT Imaging System Dragonfly |
Optical Coherence Tomography (OCT) Coronary Stent IMplantation Angiography |
|
Coronary Artery Disease Myocardial Infarction Atherosclerosis ST Elevation Myocardial Infarction Coronary Stenosis Infarction Ischemia Pathologic Processes |
Necrosis Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |