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

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-09

Study Completion Date

2026-03-31

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.

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BioMatrix Alpha

All patients will receive the BioMatrix Alpha as per treatment.

Group Type EXPERIMENTAL

BioMatrix Alpha

Intervention Type DEVICE

Patient will be treated with BioMatrix Alpha

Interventions

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BioMatrix Alpha

Patient will be treated with BioMatrix Alpha

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No