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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SYNERGY stent
ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, ST (Software Test) -elevation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Didier CARRIE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SYNERGY Stent

BVS device

Arm 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.

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.

Outcomes

Primary Outcome Measures

Number of uncovered stent struts at 3-months
To assess strut coverage

Secondary Outcome Measures

Percentage of malposed uncovered struts
Assessed by optical coherence tomography
Frequency of abnormal intrastent tissue
Assessed by optical coherence tomography
Percentage of net volume obstruction
Assessed by optical coherence tomography
Rates of in-stent late loss
Rates of in-segment late loss
Rates of binary restenosis
Plasma CXCL10 protein as a potential of re-endothelialization

Full Information

First Posted
June 28, 2016
Last Updated
August 19, 2019
Sponsor
University Hospital, Toulouse
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02890589
Brief Title
Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction
Acronym
COVER-AMI
Official Title
Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute coronary syndrome, ST (Software Test) -elevation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SYNERGY Stent
Arm Type
Experimental
Arm 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.
Arm Title
BVS device
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
SYNERGY stent
Other Intervention Name(s)
SYNERGY (Platinum chromium coronary stent)
Intervention Description
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
Intervention Name(s)
ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)
Other Intervention Name(s)
ABSORB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of uncovered stent struts at 3-months
Description
To assess strut coverage
Time Frame
at 3-months
Secondary Outcome Measure Information:
Title
Percentage of malposed uncovered struts
Description
Assessed by optical coherence tomography
Time Frame
at 3 months
Title
Frequency of abnormal intrastent tissue
Description
Assessed by optical coherence tomography
Time Frame
at 3 months
Title
Percentage of net volume obstruction
Description
Assessed by optical coherence tomography
Time Frame
at 3 months
Title
Rates of in-stent late loss
Time Frame
at 3 months
Title
Rates of in-segment late loss
Time Frame
at 3 months
Title
Rates of binary restenosis
Time Frame
at 3 months
Title
Plasma CXCL10 protein as a potential of re-endothelialization
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier CARRIE, MD Phd
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Didier CARRIE
City
Toulouse
ZIP/Postal Code
31500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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