ENdothelial Healing Assessment With Novel Coronary tEchnology

Study Overview
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Brief Summary
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This is a prospective, non-randomized, single center clinical trial to assess neointimal coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of 12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using OCT and CAS

Detailed Description
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All of the subject will received SYNERGY™ stent in one of the blocked coronary artery and ABSORB scaffold strut in the other artery. All subjects must have 2 coronary arteries stenosis of more than 70%.

Official Title
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Comparison Between SYNERGY™ vs. Bioresorbable Vascular Scaffold (BVS) ABSORB Neointimal Formation Assessed by (Optical Coherence Tomography) OCT and Coronary Angioscopy (CAS) Evaluation (The ENHANCE Study - ENdothelial Healing Assessment With Novel Coronary tEchnology)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: SYNERGY stent
* Device: BVS ABSORB scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 20 years old or older Subject or legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements. Subject must have evidence of myocardial ischemia (eg stable or unstable angina, silent ischemia) suitable for elective PCI Significant narrowing of at least 70% stenosis of de novo lesion (QCA or visual estimation) in 2 different native coronary arteries. Subject is eligible for to undergo OCT and CAS examination at 4 months and 12 months after stent or scaffold implantation. Subject is able to take dual anti-platelet therapy up to one year following the index procedure and anticoagulants prior/during the index procedure Exclusion Criteria: Subject had an acute myocardial infarction (STEMI or NSTEMI) within 24 hours of the index procedure Subject has known left ventricular ejection fraction (LVEF) < 30% Subject is receiving hemodialysis Target vessel were treated by PCI within 12 months Target lesion is located within a saphenous vein graft or an arterial graft Target lesion is located in ostium Target lesion is located highly tortuous equal to or greater than 60 degrees Target lesion with TIMI flow 0 (total occlusion)

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coronary artery implanted with SYNERGY stent<br>One of the blocked coronary artery of a patient will received SYNERGY stent | Device: SYNERGY stent<br> <br> |
| Active Comparator: Coronary artery implanted with ABSORB scaffold<br>Another blocked coronary artery of the same patient will received ABSORB scaffold | Device: BVS ABSORB scaffold<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apposition and neointimal coverage on the stent and scaffold strut | Neointimal coverage on the stent and scaffold strut and their apposition using OCT and CAS at 4 month after the stent implantation. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apposition and neointimal coverage on the stent and scaffold strut | Neointimal coverage on the stent or scaffold and their apposition using OCT and CAS at 12 month after stent implantation | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SYNERGY, Neointimal formation, OCT, coronary angioscopy, coronary artery disease