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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioMatrix AlphaTM (Cobalt Chromium Biolimus A9TM Drug-eluting Stent) - ALPHA LONG Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: BioMatrix Alpha


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must provide written informed consent Patient is at least 18 years old 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 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 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 Hemodynamically stable patients Exclusion Criteria: Inability to provide informed consent Currently participating in another clinical trial Planned surgery ≤6 months of PCI unless DAPT or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period Planned use of additional stents other than BioMatrix AlphaTM during the index procedure. Patients with a life expectancy of < 1 year 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioMatrix Alpha<br>All patients will receive the BioMatrix Alpha as per treatment. | Device: BioMatrix Alpha<br>* Patient will be treated with BioMatrix Alpha<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Target Lesion Failure (TLF) | 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) | at 9 months after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Cardiovascular Death (CD) | Incidence | at 9 months after index procedure | 
| Number of participants with Target Vessel Myocardial Infarction | Target Vessel Myocardial Infarction (TV-MI) | at 9 months after index procedure | 
| Number of participants with Clinically indicated Target Lesion Revascularization | Clinically indicated Target Lesion Revascularization (ci-TLR) | at 9 months after index procedure | 
| Number of participants with Target Vessel Revascularization | Target Vessel Revascularization (TVR) | at 9 months after index procedure | 
| Number of participants with Stent thrombosis (definite and/or probable) | incidence | at 9 months after index procedure | 
| Number of of participants with All-cause mortality | incidence | at 9 months after index procedure |