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

Completed

• Conditions: Stable Angina; NSTEMI - Non-ST Segment Elevation MI; Unstable Angina; STEMI; ACS - Acute Coronary Syndrome; Myocardial Infarction

• Registration Number: NCT03103620
• Lead Sponsor: CeloNova BioSciences, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-10
• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1027

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE	12 months	Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Stent thrombosis	12 months	Stent thrombosis (according to ARC definition)
TVR and TLR	12 months	Target vessel and lesion revascularization
DAPT	12 months	Mean length of dual antiplatelet therapy

Trial Locations

Locations (15)

SCM Angioscan; 🇫🇷 Antony, France

Clinique Axium; 🇫🇷 Aix, France

GCS Cardio; 🇫🇷 Annecy, France

Clinique La Casamance; 🇫🇷 Aubagne, France

Centre Hospitalier; 🇫🇷 Pau, France

Clinique La Fourcade; 🇫🇷 Bayonne, France

Clinique des Domes; 🇫🇷 Clermont, France

Clinique Cardiologie; 🇫🇷 Evecquemont, France

Clinique Mutualiste; 🇫🇷 Grenoble, France

Infirmerie Protestante; 🇫🇷 Lyon, France

Clinique St-Martin; 🇫🇷 Pessac, France

Clinique du Pont de Chaume; 🇫🇷 Montauban, France

Clinique St Hilaire; 🇫🇷 Rouen, France

Polyclinique de Courlancy; 🇫🇷 Reims, France

Clinique du Millenaire; 🇫🇷 Montpellier, France