Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction (COVER-AMI)

Toulouse University Hospital

Status: Completed

Conditions: Acute Coronary Syndrome

Treatments: Device: SYNERGY stent; Device: ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02890589

RC31/15/7743

Details and patient eligibility

About

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.

Full description

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

SYNERGY Stent

Experimental group

Description:

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.

Treatment:

Device: SYNERGY stent

BVS device

Experimental group

Description:

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.

Treatment:

Device: ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)