NCT02890589

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

December 5, 2025

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

June 28, 2016

Last Update Submit

November 27, 2025

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndromeST (Software Test) -elevation

Outcome Measures

Primary Outcomes (1)

  • Number of uncovered stent struts at 3-months

    To assess strut coverage

    at 3-months

Secondary Outcomes (7)

  • Percentage of malposed uncovered struts

    at 3 months

  • Frequency of abnormal intrastent tissue

    at 3 months

  • Percentage of net volume obstruction

    at 3 months

  • Rates of in-stent late loss

    at 3 months

  • Rates of in-segment late loss

    at 3 months

  • +2 more secondary outcomes

Study Arms (2)

SYNERGY Stent

EXPERIMENTAL

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

BVS device

EXPERIMENTAL

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)

Interventions

SYNERGY stentDEVICE

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.

Also known as: SYNERGY (Platinum chromium coronary stent)
SYNERGY Stent
ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)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.

Also known as: ABSORB
BVS device

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Didier CARRIE

Toulouse, Toulouse, 31500, France

Location

Related Publications (1)

  • 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.

    PMID: 30975219RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Didier CARRIE, MD Phd

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

September 7, 2016

Study Start

July 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

December 5, 2025

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)