BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
- Conditions
- Stable AnginaNSTEMICoronary Artery DiseaseIschemiaAcute Coronary SyndromeSTEMI
- Registration Number
- NCT02871622
- Lead Sponsor
- Biosensors Europe SA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). 9 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Craigavon Cardiac Center
🇬🇧Craigavon, United Kingdom