BioMatrix Alpha: Patient will be treated with BioMatrix Alpha
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of participants with Target Lesion Failure (TLF) — at 9 months after index procedure Primary endpoint is the rate of Target Lesion Failure (TLF) at 9 months defined as cardiovascular death or target vessel myocardial infarction or clinically indicated target lesion revascularization (TLR)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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