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.
Sponsor
Sponsors
Primary endpoints
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.
- Clinical trial documentation,
- Submission,
- Set-up activities,
- eCRF / data-management,
- Monitoring,
- CEC
CERC Services
- Clinical trial documentation
- Regulatory submissions
- Set-up activities (sites selection, insurance management, contract management)
- CRF and Data management
- Monitoring activities
- Clinical Events Committee (CEC) activities
Countries
UK, Spain, Switzerland, Thailand.
Number of investigational sites
12
Number of patients
40 patients expected
