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

NCT ID: NCT02890589

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-02-28

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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SYNERGY Stent

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.

Group Type EXPERIMENTAL

SYNERGY stent

Intervention Type DEVICE

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.

BVS device

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.

Group Type EXPERIMENTAL

ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)

Intervention Type DEVICE

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.

Interventions

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SYNERGY stent

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.

Intervention Type DEVICE

ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)

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.

Intervention Type DEVICE

Other Intervention Names

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SYNERGY (Platinum chromium coronary stent) ABSORB

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didier CARRIE, MD Phd

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Didier CARRIE

Toulouse, Toulouse, France

Site Status

Countries

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France

References

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Lhermusier T, Ohayon P, Boudou N, Bouisset F, Campelo-Parada F, Roncalli J, Elbaz M, Carrie D. Re-endothelialisation after Synergy stent and Absorb bioresorbable vascular scaffold implantation in acute myocardial infarction: COVER-AMI study. Trials. 2019 Apr 11;20(1):210. doi: 10.1186/s13063-019-3293-8.

Reference Type RESULT
PMID: 30975219 (View on PubMed)

Other Identifiers

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RC31/15/7743

Identifier Type: -

Identifier Source: org_study_id

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