Coronary Artery Disease
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEBioMatrix Alpha
Patient will be treated with BioMatrix Alpha
Sponsors
Biosensors Europe SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center, open-label single-arm study. 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/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Target Vessel Myocardial Infarction | at 9 months after index procedure | Target Vessel Myocardial Infarction (TV-MI) |
| Number of participants with Clinically indicated Target Lesion Revascularization | at 9 months after index procedure | Clinically indicated Target Lesion Revascularization (ci-TLR) |
| Number of participants with Cardiovascular Death (CD) | at 9 months after index procedure | Incidence |
| Number of participants with Stent thrombosis (definite and/or probable) | at 9 months after index procedure | incidence |
| Number of of participants with All-cause mortality | at 9 months after index procedure | incidence |
| Number of participants with Target Vessel Revascularization | at 9 months after index procedure | Target Vessel Revascularization (TVR) |
Countries
Germany, United Kingdom
Outcome results
None listed