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

T

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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