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

B

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

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.

Trial contacts and locations

1

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Central trial contact

Diana Schuette; Abderrahim Kadri

Data sourced from clinicaltrials.gov

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