BMX Alpha Registry

A post-market registry of the BioMatrix AlphaTM (Cobalt Chromium Biolimus
A9 TM (BA9TM) drug-eluting stent) 

Brief summary:

BMX Alpha is a prospective, multi-center, registry designed to enrol 400 patients to 12 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.

Primary endpoint:

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) at 9 months.

Countries:

UK, Spain, Switzerland, Thailand

Center number:

12 centers

CERC Asia Services:

• Clinical trial documentation
• Submission
• Set-up activities
• eCRF / data management
• Monitoring (Thailand)
• CEC