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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890589
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: SYNERGY stent Device: ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study
Actual Study Start Date : July 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: 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.
Device: 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.

Other Name: SYNERGY (Platinum chromium coronary stent)

Experimental: 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.
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.

Other Name: ABSORB




Primary Outcome Measures :
  1. Number of uncovered stent struts at 3-months [ Time Frame: at 3-months ]
    To assess strut coverage


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890589


Locations
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France
Didier CARRIE
Toulouse, France, 31500
Sponsors and Collaborators
University Hospital, Toulouse
Boston Scientific Corporation
Investigators
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Principal Investigator: Didier CARRIE, MD Phd University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02890589    
Other Study ID Numbers: RC31/15/7743
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
Acute coronary syndrome
ST (Software Test) -elevation
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chromium
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances