BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM

Biosensors Europe SA2,000 enrolled

Overview

Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Coronary Artery Disease Stable Angina Ischemia Acute Coronary Syndrome NSTEMI STEMI

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients treated with the BioMatrix AlphaTM stent per clinical indication and physician's choice; * Patients who agree to comply with the follow up requirements; * Patients with a life expectancy of \> 1 year at time of consent; * Patients eligible to receive dual anti platelet therapy (DAPT) according to guidelines; * Hemodynamically stable patients. Exclusion Criteria: * Inability to provide informed consent; * Currently participating in another trial before reaching primary endpoint; * Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the perisurgical period; * Patient has received an additional stent different from a BioMatrix AlphaTM stent during the index procedure.

Outcomes

Primary Outcomes

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).

Time frame: 9 months

Data from ClinicalTrials.gov

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