BMX Alpha Registry
Research type
Research Study
Full title
A post-market registry of the BioMatrix Alpha TM (Cobalt Chromium Biolimus A9TM (BA9TM) drug-eluting stent)
IRAS ID
212991
Contact name
Diana Schuette
Contact email
Sponsor organisation
Biosensors Europe SA
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The registry is being done to capture safety and effectiveness data on the BioMatrix AlphaTM stent in a “real world, all comers” population.
It is a prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 International centers. Patients are “Real world, all comers” with symptomatic coronary artery disease who qualify for percutaneous coronary interventions (PCI). All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be consented after the procedure for data collection and for telephone follow up for up to 2 years. The primary outcome will be major adverse cardiac events (MACE) results at 9 months which will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial.
REC name
London - Queen Square Research Ethics Committee
REC reference
16/LO/1578
Date of REC Opinion
17 Aug 2016
REC opinion
Further Information Favourable Opinion