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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease Stable Angina Ischemia Acute Coronary Syndrome NSTEMI STEMI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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BioMatrix AlphaTM

Cobalt Chromium BA9 TM drug-eluting stent

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No