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

Last updated: November 4, 2024
Sponsor: Biosensors Europe SA
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Vascular Diseases

Coronary Artery Disease

Treatment

BioMatrix Alpha

Clinical Study ID

NCT05799963
22-EU-03
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 vesseldiameter 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 Kantagonist or novel anti-coagulant) and a single anti-platelet agent

  7. Hemodynamically stable patients

Exclusion

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 combinationanti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgicalperiod

  4. Planned use of additional stents other than BioMatrix AlphaTM during the indexprocedure.

  5. Patients with a life expectancy of < 1 year

  6. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any otherP2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivityto contrast media, which cannot be adequately pre-medicated

Study Design

Total Participants: 85
Treatment Group(s): 1
Primary Treatment: BioMatrix Alpha
Phase:
Study Start date:
February 09, 2024
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Klinikum Bielefeld

    Bielefeld, 33604
    Germany

    Site Not Available

  • Krankenhaus Buchholz

    Buchholz, 21244
    Germany

    Site Not Available

  • Klinikum Lippe GmbH

    Detmold, 32758
    Germany

    Site Not Available

  • University Hospitals Birmingham (UHB)

    Birmingham,
    United Kingdom

    Site Not Available

  • Royal Blackburn Hospital

    Blackburn, BB2 3HH
    United Kingdom

    Site Not Available

  • Hull University Teaching Hospitals (HUTH)

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • United Lincolnshire Hospitals (ULH)

    Lincoln,
    United Kingdom

    Site Not Available

  • The Grange University Hospital, Newport

    Newport,
    United Kingdom

    Site Not Available

  • Royal Albert Edward Infirmary

    Wigan, WN1 2NN
    United Kingdom

    Site Not Available

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