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 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.

CERC Services

• Clinical trial documentation,
• Submission,
• Set-up activities,
• eCRF / data-management,
• Monitoring,
• CEC

Countries

UK, Spain, Switzerland, Thailand.

Center number

12 centers.