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NCT03103620 Clinical Trial

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

Myocardial Infarction Clinical Trial

— eCOBRA  

Official title:
Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03103620
Other study ID # COBRA 2013-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2015
Est. completion date December 31, 2017

Study information
Verified date August 2018
Source CeloNova BioSciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1027
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• COBRA PzF Coronary Stent System
COBRA PzF Coronary Stent System

Locations
Country Name City State
France Clinique Axium Aix
France GCS Cardio Annecy
France SCM Angioscan Antony
France Clinique La Casamance Aubagne
France Centre Hospitalier Avignon
France Clinique La Fourcade Bayonne
France Centre Hospitalier Brive
France Clinique des Domes Clermont
France Clinique Cardiologie Evecquemont
France Clinique Mutualiste Grenoble
France Centre Hospitalier Haguenau
France Infirmerie Protestante Lyon
France Clinique du Pont de Chaume Montauban
France Clinique du Millenaire Montpellier
France Centre Hospitalier Pau
France Clinique St-Martin Pessac
France Polyclinique de Courlancy Reims
France Clinique St Hilaire Rouen

Sponsors (2)
Lead Sponsor Collaborator
CeloNova BioSciences, Inc. AlpinARC

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary MACE Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization 12 months
Secondary Stent thrombosis Stent thrombosis (according to ARC definition) 12 months
Secondary TVR and TLR Target vessel and lesion revascularization 12 months
Secondary DAPT Mean length of dual antiplatelet therapy 12 months
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