Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Pragmatic Trial : Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

Conditions
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Coronary Vessels

Intervention / Treatment
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* Procedure: PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT-guided<br> | Procedure: PCI<br>* Percutaneous Coronary Intervention<br>|
| Active Comparator: IVUS-guided<br> | Procedure: PCI<br>* Percutaneous Coronary Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of target vessel failure | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cardiac Death |  | 1, and 5 years | 
| Rate of target vessel myocardial infarction |  | 1, and 5 years | 
| Rate of ischemia-driven target vessel revascularization |  | 1, and 5 years | 
| Rate of death | cardiac, vascular, non-cardiovascular death | 1, and 5 years | 
| Rate of myocardial infarction | periprocedural or spontaneous, Q-wave or non-Q-wave. | 1, and 5 years | 
| Rate of stent thrombosis | Stent thrombosis is defined according to according to the definite or probable criteria of the Academic Research Consortium. | 1, and 5 years | 
| Rate of stroke | 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. | 1, and 5 years | 
| Rate of repeat revascularization | Any, target-lesion or non-target-lesion, target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven. | 1, and 5 years | 
| Rate of any hospitalization | Cardiac or non-cardiac causes. | 1, and 5 years | 
| Rate of bleeding events | Life-threatening or disabling, major bleeding, or minor. Bleeding events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria. | 1, and 5 years | 
| Rate of target-lesion failure | Cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization | 1, and 5 years | 
| Rate of contrast-induced acute kidney injury | 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. | 3 days | 
| Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices | 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. | 1 day | 
| Rate of angiographic or imaging-based device success | 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, IVUS, PCI