COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT

• ClinicalTrials.gov Identifier: NCT01925794
• Recruitment Status: Completed
• First Posted: August 20, 2013
• Results First Posted: December 22, 2021
• Last Update Posted: December 22, 2021
• Sponsor: CeloNova BioSciences, Inc.
• Information provided by (Responsible Party): CeloNova BioSciences, Inc.

Study Description

Brief Summary:

This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: COBRA PzF	Not Applicable

Detailed Description:

The main objective of this study is to evaluate the safety and effectiveness of the COBRA PzF™ Coronary Stent System in the treatment of de novo lesions in native coronary arteries. The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the COBRA PzFTM Coronary Stent System. This rate will be compared to a performance goal derived using a meta-analysis from published historical data of the standard-of-care therapy, coronary stenting with bare metal stents.

PRIMARY STUDY HYPOTHESIS The CeloNova COBRA PzFTM Study will have a primary endpoint (TVF) rate less than 19.62% and by that will meet the performance goal for bare metal stents, per the results of the historical control group combined with relevant data for EXPRESS™, Driver™, Presillion/Presillion plus™ and NIRFLEX™ stents.

SECONDARY STUDY HYPOTHESIS The powered secondary endpoint for this trial is that the CeloNova COBRA PzFTM Study will have a 9-month in-stent late loss (LL) that meets or is lower than the performance goal of 1.1 mm.

NUMBER OF PATIENTS 296 patients will be enrolled to account for loss to follow-up, which is estimated to be approximately 5% (resulting in 281 evaluable patients), at up to 40 sites in United States and OUS. At least 40% of subjects will be enrolled in the United States.

PRIMARY ENDPOINT Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC-definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.

SECONDARY ENDPOINTS

1. All Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
2. Cardiac Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
3. Major Adverse Cardiac Events (MACE), defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
4. MI at 30, 180 and 270, 360, 720, 1080, 1440, and 1800 days CeloNova Biosciences, Inc. Confidential CeloNova COBRA PzF™ Study Protocol # COBRA 2012-01 6 07 May 14
5. Clinically driven TLR at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days
6. Stroke (ischemic and hemorrhagic) at 30, 180, 270 and 360 days
7. Clinically driven TVR at 30, 180, 270 and 360 days
8. Composite Endpoint of Cardiac Death and MI at 30, 180, 270, and 360 days
9. TVF at 30, 180, and 360 days

10. Acute Success Rates

    1. Device Success: Attainment of < 30% final residual stenosis of the target lesion using only the COBRA PzFTM Coronary Stent System.
    2. Lesion Success: Attainment of < 30% final residual stenosis of the target lesion using any percutaneous method.
    3. Procedure Success: Attainment of < 30% final residual stenosis of the target lesion and no in-hospital MACE.
11. Bleeding or Vascular Complications at hospital discharge
12. Early Stent Thrombosis (ARC defined) at 30 days
13. Late Stent Thrombosis at 180, 270, and 360 days

14. Angiographic Endpoints (on first 90 evaluable patients) at 270 days (after clinical assessment)

    1. In-stent late loss (Secondary Endpoint hypothesis)
    2. In-segment percent diameter stenosis (%DS) (within the 5 mm margins proximal and distal to stent)
    3. In-stent percent diameter stenosis (%DS)
    4. In-segment late loss
    5. In-segment binary restenosis (stenosis of > 50% of the reference vessel diameter)
    6. In-stent binary restenosis
    7. In-stent minimum lumen diameter (MLD)
    8. In-segment MLD
    9. Longitudinal stent deformation
    10. Stent fracture

15. Optical Coherence Tomography Endpoints (on 45 subjects) at 270 days (after clinical assessment)

    1. in-stent neointimal thickness (NT)
    2. Lumen area
    3. Lumen volume
    4. Stent area
    5. Stent volume
    6. Proportion of uncovered and/or malopposed struts
    7. Stent fracture

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 296 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term Dual Anti-Platelet Therapy. The PzF Shield Trial
• Study Start Date: August 21, 2013
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: March 2, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: COBRA PzF Stent; Single Arm study	Device: COBRA PzF

Outcome Measures

Primary Outcome Measures :

1. Target Vessel Failure (TVF) [ Time Frame: 270 days ]
   TVF defined as cardiac death, target vessel myocardial infarction (MI [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.

Secondary Outcome Measures :

1. All Cause Mortality [ Time Frame: 30 days ]
   Death from any cause
2. All Cause Mortality [ Time Frame: 180 days ]
   Death from any cause
3. All Cause Mortality [ Time Frame: 270 days ]
   Death from any cause
4. All Cause Mortality [ Time Frame: 360 days ]
   Death from any cause
5. All Cause Mortality [ Time Frame: 1800 days ]
   Death from any cause
6. Cardiac Mortality [ Time Frame: 30 days ]

   Death due to any of the following:

   Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

7. Cardiac Mortality [ Time Frame: 180 days ]

   Death due to any of the following:

   Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

8. Cardiac Mortality [ Time Frame: 270 days ]

   Death due to any of the following:

   Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

9. Cardiac Mortality [ Time Frame: 360 days ]

   Death due to any of the following:

   Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

10. Cardiac Mortality [ Time Frame: 1800 days ]

    Death due to any of the following:

    Acute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded

11. Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days ]
    Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
12. Major Adverse Cardiac Events (MACE) [ Time Frame: 180 days ]
    Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
13. Major Adverse Cardiac Events (MACE) [ Time Frame: 270 days ]
    Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
14. Major Adverse Cardiac Events (MACE) [ Time Frame: 360 days ]
    Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
15. Major Adverse Cardiac Events (MACE) [ Time Frame: 1800 days ]
    Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
16. Myocardial Infarction (MI-ARC Definition) [ Time Frame: 30 days ]

    Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

    NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves (historical definition). ARC definition includes Troponin or CK-MB >3 x UNL

17. Myocardial Infarction (MI-ARC Definition) [ Time Frame: 180 days ]

    Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

    NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

18. Myocardial Infarction (MI-ARC Definition) [ Time Frame: 270 days ]

    Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

    NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

19. Myocardial Infarction (MI-ARC Definition) [ Time Frame: 360 days ]

    Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

    NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

20. Myocardial Infarction (MI-ARC Definition) [ Time Frame: 1800 days ]

    Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.

    NQWMI is defined as any elevation of post-procedure CK-MB to >=3 times site normal in the absence of pathological Q waves

21. Cardiac Death or MI (ARC Definition) [ Time Frame: 30 days ]
    Composite Endpoint of Cardiac Death or MI (ARC definition)
22. Cardiac Death or MI (ARC Definition) [ Time Frame: 180 days ]
    Composite Endpoint of Cardiac Death and MI (ARC definition)
23. Cardiac Death or MI (ARC Definition) [ Time Frame: 270 days ]
    Composite Endpoint of Cardiac Death or MI (ARC definition)
24. Cardiac Death or MI (ARC Definition) [ Time Frame: 360 days ]
    Composite Endpoint of Cardiac Death or MI (ARC definition)
25. Clinically Driven TLR [ Time Frame: 30 days ]
    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.
26. Clinically Driven TLR [ Time Frame: 180 days ]
    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.
27. Clinically Driven TLR [ Time Frame: 270 days ]
    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.
28. Clinically Driven TLR (Clinical and Angiographic Cohorts) [ Time Frame: 360 days ]
    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.
29. Clinically Driven TLR (Clinical Cohorts) [ Time Frame: 360 days ]
    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.
30. Clinically Driven TLR (Clinical and Angiographic Cohorts) [ Time Frame: 1800 days ]
    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.
31. Clinically Driven TLR (Clinical Cohorts) [ Time Frame: 1800 days ]
    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.
32. Clinically Driven TVR [ Time Frame: 30 days ]
    Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.
33. Clinically Driven TVR [ Time Frame: 180 days ]
    Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.
34. Clinically Driven TVR [ Time Frame: 270 days ]
    Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.
35. Clinically Driven TVR [ Time Frame: 360 days ]
    Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >=70% by QCA without either angina or a positive functional study.
36. Target Vessel Failure (TVF) [ Time Frame: 30 days ]
    TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.
37. Target Vessel Failure (TVF) [ Time Frame: 180 days ]
    TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.
38. Target Vessel Failure (TVF) [ Time Frame: 360 days ]
    TVF defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave, ARC definition], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.
39. Stroke (Ischemic and Hemorrhagic) [ Time Frame: 30 days ]
    Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.
40. Stroke (Ischemic and Hemorrhagic) [ Time Frame: 180 days ]
    Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.
41. Stroke (Ischemic and Hemorrhagic) [ Time Frame: 270 days ]
    Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.
42. Device Success [ Time Frame: 30 days ]
    Attainment of <30% final residual stenosis of the target lesion using only the COBRA PzF Coronary Stent System
43. Stroke (Ischemic and Hemorrhagic) [ Time Frame: 360 days ]
    Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.
44. Lesion Success [ Time Frame: 30 days ]
    Attainment of <30% final residual stenosis of the target lesion using any percutaneous method
45. Procedure Success [ Time Frame: 30 days ]
    Attainment of <30% final residual stenosis of the target lesion and no in-hospital MACE
46. Bleeding or Vascular Complications [ Time Frame: 30 days ]
    Bleeding Complications: Procedure-related hemorrhagic event that requires a transfusion and/or surgical intervention Vascular Complications: May include pseudo aneurysm, arteriovenous fistula (AVF), peripheral ischemia/nerve injury, and vascular event requiring transfusion or surgical repair
47. Early Stent Thrombosis (ARC Definition) [ Time Frame: 30 days ]
    Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure
48. Late Stent Thrombosis [ Time Frame: 180 days ]
    Stent Thrombosis after 30 days and on or before 180 days
49. Late Stent Thrombosis [ Time Frame: 270 days ]
    Stent Thrombosis after 30 days and on or before 270 days
50. Late Stent Thrombosis [ Time Frame: 360 days ]
    Stent Thrombosis after 30 days and on or before 360 days
51. Definite and Probable Stent Thrombosis [ Time Frame: 1800 days ]
    Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of >= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of >=70% by QCA without either angina or a positive functional study.
52. In-Segment Percent Diameter Stenosis [ Time Frame: 270 days ]
    Relative changes that occur in the percent diameter stenosis of the segment and are provided by the following relationship: % diameter stenosis= (1-[MLD/Reference diameter]) x 100
53. In-Stent and In-Segment MLD and Late Loss [ Time Frame: 270 days ]
    • In-stent and in-Segment minimal lumen diameter obtained immediately after stent implantation and at angiographic assessment at 270 days.
    • In-stent or in-segment late loss was defined as the difference between minimum lumen diameter (in-stent or in-segment) immediately after implantation and that obtained at angiographic follow-up at 270 days.
54. Angiographic Endpoints [ Time Frame: 270 days ]
    Angiographic subset included 115 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 115.
55. In-stent Neointimal Thickness (INT) [ Time Frame: 270 days ]
    in-stent neointimal thickness assessed by Optical Coherence Tomography
56. Percentage of Uncovered and/or Malapposed Struts [ Time Frame: 270 days ]
    This measure assess the average proportion of uncovered and or malapposed struts measured by Optical Coherence Tomography in participants
57. Lumen and Stent Area Measurements [ Time Frame: 270 days ]
    Optical Coherence Tomography assessment of the lumen and stent area after the clinical follow up at 270 days
58. Lumen and Stent Volume [ Time Frame: 270 days ]
    Optical Coherence Tomography assessment of the lumen and stent volume after the clinical follow up at 270 days

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

General Inclusion Criteria:

1. Patient >/= to 18 years old.
2. Eligible for percutaneous coronary intervention (PCI).
3. Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
4. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
5. Acceptable candidate for coronary artery bypass graft (CABG) surgery.
6. Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).
7. Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).

Angiographic Inclusion Criteria

1. Patient indicated for elective stenting of a single stenotic lesion in a native coronary artery.
2. Reference vessel >/= 2.5 mm and </= 4.0 mm in diameter by visual estimate.
3. Target lesion </= 24 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length).
4. Protected left main lesion with >50% stenosis.
5. Target lesion stenosis >/= 70% and < 100% by visual estimate.
6. Target lesion stenosis <70% who meet physiological criteria for revascularization (i.e. positive FFR).

General Exclusion Criteria:

1. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
2. Previously enrolled in another stent trial within the prior 2 years.
3. ANY planned elective surgery or percutaneous intervention within the subsequent 3 months.
4. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
5. The patient requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
6. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
7. Previous drug eluting stent (DES) deployment anywhere in the target vessel.
8. Any previous stent placement within 15 mm (proximal or distal) of the target lesion.
9. Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
10. Concurrent medical condition with a life expectancy of less than 12 months.
11. Documented left ventricular ejection fraction (LVEF) < 30% within 12 months prior to enrollment.
12. Patients with diagnosis of MI within 72 hours (i.e. CK-MB must be returned to normal prior to enrollment) or suspected acute MI at time of enrollment
13. Previous brachytherapy in the target vessel.
14. History of cerebrovascular accident or transient ischemic attack in the last 6 months.
15. Leukopenia (leukocytes < 3.5 x 10(9) / liter).
16. Neutropenia (Absolute Neutrophil Count < 1000/mm3) </= 3 days prior to enrollment.
17. Thrombocytopenia (platelets < 100,000/mm3) pre-procedure.
18. Active peptic ulcer or active GI bleeding.
19. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
20. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.
21. Serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.
22. Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post procedure.

Angiographic Exclusion Criteria

1. Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the LAD or Circumflex artery or a branch thereof).
2. Target vessel with any lesions with greater than 50% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA.
3. Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time.
4. Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
5. Target lesion with side branches > 2.0mm in diameter.
6. Target vessel is excessively tortuous (two bends > 90˚ to reach the target lesion).
7. Target lesion is severely calcified.
8. TIMI flow 0 or 1
9. Target lesion is in a bypass graft

Contacts and Locations

Locations

United States, California

Bakersfield Memorial Hospital

Bakersfield, California, United States, 93303

United States, Florida

Mt Sinai Medical Center

Miami Beach, Florida, United States, 33140

United States, Georgia

Emory University Hospital

Atlanta, Georgia, United States, 30322

United States, Indiana

Heart Center of Indiana

Indianapolis, Indiana, United States, 46290

United States, Louisiana

Louisiana Heart Hospital

Lacombe, Louisiana, United States, 70445

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, New Jersey

Deborah Heart & Lung Center

Browns Mills, New Jersey, United States, 08015

United States, New York

St Joseph's Hospital

Liverpool, New York, United States, 13088

Lenox Hill Hospital

New York, New York, United States, 10075

Mount Sinai Hospital

New York, New York, United States, 11029

United States, Oklahoma

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, United States, 73120

United States, Oregon

Southern Oregon Cardiology

Medford, Oregon, United States, 97504

United States, Pennsylvania

York General Hospital

York, Pennsylvania, United States, 17403

United States, Texas

Cardiology Consultants of Texas

Dallas, Texas, United States, 75226

Plaza Medical Center

Fort Worth, Texas, United States, 76104

Houston Methodist Hospital

Houston, Texas, United States, 77030

Texas Cardiac Center

Lubbock, Texas, United States, 79410

The Heart Hospital Baylor Plano

Plano, Texas, United States, 75093

San Antonio Endovascular & Heart Institute

San Antonio, Texas, United States, 78258

Tyler Cardiovascular Consultants

Tyler, Texas, United States, 75701

United States, Virginia

Virginia Cardiovascular Specialists

Richmond, Virginia, United States, 23229

United States, Wisconsin

Aspirus Heart & Vascular Institute

Wausau, Wisconsin, United States, 54401

France

Clinique Axium

Aix en Provence, France, 13097

Hopital Henri Duffaut

Avignon, France, 84902

Albert Schweitzer Hospital

Colmar, France, 68000

Clinique du Diaconat

Mulhouse, France, 68100

Centre Hospitalier de Pau

Pau, France, 64046

Clinique St. Hilaire

Rouen, France, 76600

Germany

Sankt Kathatinen Hospital

Frankfurt, Germany, 60389

Kardiologische Praxis und Praxisklinik

Munchen, Germany, 81379

Latvia

Paul Stradins Clinical University Hospital

Riga, Latvia, 2166

Serbia

Clinical Center of Serbia

Belgrade, Serbia, 11000

Spain

Hospital de la Santa Creu

Barcelona, Spain, 08025

Hospital Clinico San Carlos

Madrid, Spain, 28040

Switzerland

Kantonsspital St. Gallen

St. Gallen, Switzerland, CH-9007

Sponsors and Collaborators

CeloNova BioSciences, Inc.

Investigators

• Principal Investigator: Donald Cutlip, MD; Executive Director, Clinical Investigation, Harvard Clinical Research Institute
• Principal Investigator: Sigmund Sliber, MD; Professor of Medicine at The University of Munich

More Information

• Responsible Party: CeloNova BioSciences, Inc.
• ClinicalTrials.gov Identifier: NCT01925794
• Other Study ID Numbers: COBRA 2012-01
• First Posted: August 20, 2013
• Results First Posted: December 22, 2021
• Last Update Posted: December 22, 2021
• Last Verified: March 2021

Keywords provided by CeloNova BioSciences, Inc.:

Stent, Coronary Arteries for Early healing

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases