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

CeloNova BioSciences

Status: Completed

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

Treatments: Device: COBRA PzF Coronary Stent System

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03103620

COBRA 2013-01

Details and patient eligibility

About

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.

Enrollment: 1,027 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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