ACS - Acute Coronary Syndrome, Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, Stable Angina, STEMI, Unstable Angina
Conditions
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.
Interventions
DEVICECOBRA PzF Coronary Stent System
COBRA PzF Coronary Stent System
Sponsors
AlpinARC
CeloNova BioSciences, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 12 months | Composite clinical endpoint of cardiac death, myocardial infarction, and clinically driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed