Myocardial Infarction Clinical Trial
— eCOBRAOfficial title:
Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry
Verified date | August 2018 |
Source | CeloNova BioSciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
CeloNova BioSciences, Inc. | AlpinARC |
France,
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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