ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD

Biosensors International

Status: Active, not recruiting

Conditions: Coronary Artery Disease

Treatments: Device: BioMatrix Alpha

Study type: Interventional

Funder types: Industry

Identifiers

NCT05799963

22-EU-03

Details and patient eligibility

About

Prospective, multi-center, open-label single-arm study designed to enroll 85 patients in up to 15 centers in up to 3 European countries.

All patients will be followed up for 9 months. The "BMX Alpha Registry" study will serve as reference and historic comparator.

Full description

The objective of this study is to evaluate if PCI performed using the additional sizes of the BioMatrix AlphaTM stent results in similar safety and efficacy outcomes as the currently approved (CE marked) sizes of BioMatrix Alpha.

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must provide written informed consent
2. Patient is at least 18 years old
3. Patients scheduled to undergo PCI of a de novo lesion(s) with reference vessel diameter and lesion length suitable for treatment with at least one study device
4. Patients who agree to comply with the follow up requirements
5. Patients with a life expectancy of > 1 year at time of consent
6. Patients eligible to receive for ≥6 months either dual anti-platelet therapy (DAPT, i.e. 75 mg clopidogrel or another P2Y12 inhibitor per choice of the investigator, and 75-100 mg aspirin) or a combination of an oral anti-coagulant (Vitamin K antagonist or novel anti-coagulant) and a single anti-platelet agent
7. Hemodynamically stable patients

Exclusion criteria

1. Inability to provide informed consent
2. Currently participating in another clinical trial
3. Planned surgery ≤6 months of PCI unless DAPT or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period
4. Planned use of additional stents other than BioMatrix AlphaTM during the index procedure.
5. Patients with a life expectancy of < 1 year
6. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

BioMatrix Alpha

Experimental group

Description:

All patients will receive the BioMatrix Alpha as per treatment.

Treatment:

Device: BioMatrix Alpha