Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction

Study Overview
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Brief Summary
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To assess strut coverage in patients presenting an acute myocardial infarction and treated either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel group design.

Detailed Description
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Single center, simple-blind randomized controlled trial, comparing the SYNERGY stent with the BVS device through a parallel group design.

Official Title
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Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: SYNERGY stent
* Device: ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute coronary syndrome with ST-elevation, One culprit lesion eligible for percutaneous coronary intervention (PCI) with stent implantation, Reference vessel measuring 2.5 mm to 3.75 mm per visual estimation, without extreme vessel tortuosity, thrombolysis in myocardial infarction (TIMI) 3 flow before stent deployment in the target vessel, Patient with at least 1 lesion eligible for planned PCI next to the culprit lesion, Patient affiliated to the French national health care system, Patient agreed to participate after full information on the study (signature of an informed consent). Exclusion Criteria: Acute coronary syndrome with ST-elevation, One culprit lesion eligible for percutaneous coronary intervention (PCI) with stent implantation, Reference vessel measuring 2.5 mm to 3.75 mm per visual estimation, without extreme vessel tortuosity, TIMI 3 flow before stent deployment in the target vessel, Patient with at least 1 lesion eligible for planned PCI next to the culprit lesion, Patient affiliated to the French national health care system, Patient agreed to participate after full information on the study (signature of an informed consent).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYNERGY Stent<br>The SYNERGY™ stent is a Device marked CE (European Conformity), platinum chromium coronary stent, currently developped by Boston Scientific™. This stent has been designed with the goal of providing optimal and rapid healing within the vessel using a bioabsorbable polymer to elute everolimus. | Device: SYNERGY stent<br>* Coronary angiography will assess the presence of at least one eligible coronary lesion requiring stent implantation before revascularization by angioplasty. Stent will be implanted according to manufacturer's and competent authority recommendations.<br>* Other names: SYNERGY (Platinum chromium coronary stent);|
| Experimental: BVS device<br>The ABSORB Everolimus-eluting Bioresorbable Vascular Scaffold (BVS 1.1, Abbott Vascular, California, USA, CE approved) is Device marked CE, currently the most studied PLA (Polylactic acid) based scaffold. It consists of PLLA (Poly I-lactic acid) backbone with 1:1 PDLLA (Poly-DL Lactic Acid) drug surface coating and a total strut thickness of 156 μm. | Device: ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)<br>* Coronary angiography will assess the presence of at least one eligible coronary lesion requiring stent implantation before revascularization by angioplasty. Stent will be implanted according to manufacturer's and competent authority recommendations.<br>* Other names: ABSORB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of uncovered stent struts at 3-months | To assess strut coverage | at 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of malposed uncovered struts | Assessed by optical coherence tomography | at 3 months | 
| Frequency of abnormal intrastent tissue | Assessed by optical coherence tomography | at 3 months | 
| Percentage of net volume obstruction | Assessed by optical coherence tomography | at 3 months | 
| Rates of in-stent late loss |  | at 3 months | 
| Rates of in-segment late loss |  | at 3 months | 
| Rates of binary restenosis |  | at 3 months | 
| Plasma CXCL10 protein as a potential of re-endothelialization |  | at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute coronary syndrome, ST (Software Test) -elevation