BMX Alpha

BMX Alpha

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.

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