Acute Coronary Syndrome, Coronary Artery Disease, Ischemia, NSTEMI, Stable Angina, STEMI
Conditions
Brief summary
Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be followed for 2 years for data collection. Major adverse cardiac events (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial.
Interventions
DEVICEBioMatrix AlphaTM
Cobalt Chromium BA9 TM drug-eluting stent
Sponsors
European Cardiovascular Research Center
Biosensors Europe SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients treated with the BioMatrix AlphaTM stent per clinical indication and physician's choice; * Patients who agree to comply with the follow up requirements; * Patients with a life expectancy of \> 1 year at time of consent; * Patients eligible to receive dual anti platelet therapy (DAPT) according to guidelines; * Hemodynamically stable patients.
Exclusion criteria
* Inability to provide informed consent; * Currently participating in another trial before reaching primary endpoint; * Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the perisurgical period; * Patient has received an additional stent different from a BioMatrix AlphaTM stent during the index procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or clinically driven target vessel revascularization (TVR). | 9 months |
Countries
United Kingdom
Contacts
Primary ContactDiana Schuette
Backup ContactAbderrahim Kadri
Outcome results
None listed