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Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention (OCTIVUS)

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ClinicalTrials.gov Identifier: NCT03394079
Recruitment Status : Active, not recruiting
First Posted : January 9, 2018
Last Update Posted : December 20, 2023
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Brief Summary:

The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies in patients undergoing Percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) or drug-coated balloons (only for in-stent restenosis) for significant obstructive Coronary artery disease (CAD).

The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure (cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-vessel revascularization [TVR]) at 1 year after randomization.


Condition or disease Intervention/treatment Phase
Coronary Vessels Procedure: PCI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2008 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Pragmatic Trial : Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention
Actual Study Start Date : April 12, 2018
Actual Primary Completion Date : February 17, 2023
Estimated Study Completion Date : January 31, 2028

Arm Intervention/treatment
Experimental: OCT-guided Procedure: PCI
Percutaneous Coronary Intervention

Active Comparator: IVUS-guided Procedure: PCI
Percutaneous Coronary Intervention




Primary Outcome Measures :
  1. Rate of target vessel failure [ Time Frame: 1 year ]

    A composite of cardiac death, target-vessel MI or ischemia-driven TVR) at 1 year after randomization.

    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.



Secondary Outcome Measures :
  1. Rate of cardiac Death [ Time Frame: 1, and 5 years ]
  2. Rate of target vessel myocardial infarction [ Time Frame: 1, and 5 years ]
  3. Rate of ischemia-driven target vessel revascularization [ Time Frame: 1, and 5 years ]
  4. Rate of death [ Time Frame: 1, and 5 years ]
    cardiac, vascular, non-cardiovascular death

  5. Rate of myocardial infarction [ Time Frame: 1, and 5 years ]
    periprocedural or spontaneous, Q-wave or non-Q-wave.

  6. Rate of stent thrombosis [ Time Frame: 1, and 5 years ]
    Stent thrombosis is defined according to according to the definite or probable criteria of the Academic Research Consortium.

  7. Rate of stroke [ Time Frame: 1, and 5 years ]
    Stroke is defined as focal loss of neurologic function caused by an ischemic or hemorrhagic event, with residual symptoms lasting at least 24 hours or leading to death.

  8. Rate of repeat revascularization [ Time Frame: 1, and 5 years ]
    Any, target-lesion or non-target-lesion, target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven.

  9. Rate of any hospitalization [ Time Frame: 1, and 5 years ]
    Cardiac or non-cardiac causes.

  10. Rate of bleeding events [ Time Frame: 1, and 5 years ]

    Life-threatening or disabling, major bleeding, or minor.

    Bleeding events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria.


  11. Rate of target-lesion failure [ Time Frame: 1, and 5 years ]
    Cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

  12. Rate of contrast-induced acute kidney injury [ Time Frame: 3 days ]
    Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dl within 72 hours after PCI.

  13. Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices [ Time Frame: 1 day ]
    Procedural complications (e.g., angiographic dissection of at least type B, coronary perforation, vasospasm, thrombus formation, air embolization, slow flow or no reflow, distal embolization, acute closure, ventricular arrhythmia, cardiac tamponade, or cardiogenic shock) requiring active interventions (prolonged balloon inflations, additional stenting required, thrombus aspiration, pericardiocentesis, cardioversion, or use of mechanical circulatory support devices), which are related to PCI procedures or intravascular imaging evaluation.

  14. Rate of angiographic or imaging-based device success [ Time Frame: 1 day ]

    Patient- or lesion-level analysis.

    Angiographic device success is defined as successful PCI at the intended target-lesion with final in-stent residual stenosis of less than 30% by quantitative coronary angiography (QCA). Imaging-based device success is defined as successful PCI at the intended target-lesion, which fulfills the optimal criterial for stent implantation by IVUS or OCT.




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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women at least 19 years of age
  • Subjects with obstructive CAD undergoing PCI with contemporary DES or drug-coated balloons (only for in-stent restenosis) under intracoronary imaging guidance.
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  • ST-elevation myocardial infarction
  • Severe renal dysfunction (eGFR <30 ml/min/1.73 m2 or serum creatinine level >1.5 mg/dl), unless patient is on renal replacement therapy.
  • Cardiogenic shock or decompensated heart failure with severe LV dysfunction (LVEF) < 30%
  • Life expectancy < 1 year for any non-cardiac or cardiac causes
  • Any lesion characteristics resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre- and post-PCI (eg, moderate or severe vessel calcification or tortuosity)
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
  • Unwillingness or inability to comply with the procedures described in this protocol

Information from the National Library of Medicine

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): NCT03394079


Locations
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Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Konyang University Hospital
Daejeon, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Asan Medical Hospital
Seoul, Korea, Republic of
Chung-Ang university hospital
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Kyung hee university hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
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Principal Investigator: Duk-woo Park, MD Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seung-Jung Park, Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03394079    
Other Study ID Numbers: AMCCV2017-10
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: December 20, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seung-Jung Park, Asan Medical Center:
OCT
IVUS
PCI