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Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry (eCOBRA)

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ClinicalTrials.gov Identifier: NCT03103620
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
AlpinARC
Information provided by (Responsible Party):
CeloNova BioSciences, Inc.

Study Description
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Brief Summary:
A multi-center, prospective, consecutive enrolled, observational registry. The population being studied includes all patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system. The registry will primarily assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization.

Condition or disease Intervention/treatment
Stable Angina Unstable Angina ACS - Acute Coronary Syndrome STEMI NSTEMI - Non-ST Segment Elevation MI Myocardial Infarction Device: COBRA PzF Coronary Stent System

Study Design
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Study Type : Observational
Actual Enrollment : 1027 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry
Actual Study Start Date : September 10, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017
Groups and Cohorts
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Intervention Details:
  • Device: COBRA PzF Coronary Stent System
    COBRA PzF Coronary Stent System

Outcome Measures
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Primary Outcome Measures :
  1. MACE [ Time Frame: 12 months ]
    Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization


Secondary Outcome Measures :
  1. Stent thrombosis [ Time Frame: 12 months ]
    Stent thrombosis (according to ARC definition)

  2. TVR and TLR [ Time Frame: 12 months ]
    Target vessel and lesion revascularization

  3. DAPT [ Time Frame: 12 months ]
    Mean length of dual antiplatelet therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system
Criteria

Inclusion Criteria:

Patient has given oral consent to participate in the registry Patient is implanted with a COBRA PzF stent Target lesion(s) is/are "de novo"

Exclusion Criteria:

Pregnancy Age <18 years Refusal or inability to give oral consent

Contacts and Locations
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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): NCT03103620


Locations
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Sponsors and Collaborators
CeloNova BioSciences, Inc.
AlpinARC
Investigators
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Principal Investigator: Luc Maillard, MD Clinique Axium
More Information
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Responsible Party: CeloNova BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT03103620    
Other Study ID Numbers: COBRA 2013-01
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Angina, Stable
Angina, Unstable
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations