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Completed

NCT Number: NCT02890589

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Didier CARRIE

Toulouse, 31500, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Synergy Stent

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.

Other names: SYNERGY (Platinum chromium coronary 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.

Other names: ABSORB

Primary outcomes

  1. Number of uncovered stent struts at 3-months

    Time frame: at 3-months

    To assess strut coverage

Secondary outcomes

  1. Percentage of malposed uncovered struts

    Time frame: at 3 months

    Assessed by optical coherence tomography

  2. Frequency of abnormal intrastent tissue

    Time frame: at 3 months

    Assessed by optical coherence tomography

  3. Percentage of net volume obstruction

    Time frame: at 3 months

    Assessed by optical coherence tomography

  4. Rates of in-stent late loss

    Time frame: at 3 months

  5. Rates of in-segment late loss

    Time frame: at 3 months

  6. Rates of binary restenosis

    Time frame: at 3 months

  7. Plasma CXCL10 protein as a potential of re-endothelialization

    Time frame: at 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: COVER-AMI

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2016
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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