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

Biosensors International

Status: Unknown

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Stable Angina; NSTEMI; Ischemia; STEMI

Treatments: Device: BioMatrix AlphaTM

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT02871622

16EU01

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.