Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation

Study Overview
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Brief Summary
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The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by OCT at 1-year follow-up.

Official Title
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Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Optical coherent tomography
* Other: IntraVascular UltraSound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 years or older Patients who have at least one epicardial coronary artery lesion with an evidence of inducible ischemia Willing and able to provide informed written consent Eligible for PCI Exclusion Criteria: Patients presenting with STEMI within 2 weeks Bypass graft lesion Lesion with left main disease Expected length of scaffold > 40 mm Bifurcation lesion requiring side branch stenting Small vessels < 2.75 mm Stented lesion Suspected coronary spasm even after sufficient nitrate injected Cases in which the IVUS or OCT imaging catheter failed to cross the lesion Poor quality IVUS or OCT images Contraindication to dual anti-platelet therapy Chronic total occlusion Angiographically large-sized vessel (>3.5mm of reference lumen diameter) Life expectancy shorter than 2 years Pregnancy

Ages Eligible for Study
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Minimum Age: 20 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optical coherent tomography<br>Optical coherent tomography provides more detailed information about the morphology of scaffolds, microstructures and coronary vasculature based on tissue characteristics as compared to conventional IVUS. In spite of angiographic success in BVS placement, further scaffold optimization was required in over a quarter of cases based on OCT findings due to malapposition or scaffold under expansion. | Other: Optical coherent tomography<br>* comparative method for BVS<br>|
| Active Comparator: IntraVascular UltraSound<br>Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement. | Other: IntraVascular UltraSound<br>* The method of goldstandard for decision stent choice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT-measured in-scaffold minimal lumen area |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT-measured minimal scaffold area (MSA) |  | 1 year | 
| OCT-measured mean scaffold expansion |  | 1 year | 

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