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ACTIVE NOT RECRUITING
NCT05799963
NA

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

Sponsor: Biosensors Europe SA

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2024-02-09

Completion Date

2026-03-31

Last Updated

2024-11-05

Healthy Volunteers

No

Interventions

DEVICE

BioMatrix Alpha

Patient will be treated with BioMatrix Alpha

Locations (9)

Klinikum Bielefeld

Bielefeld, Germany

Krankenhaus Buchholz

Buchholz, Germany

Klinikum Lippe GmbH

Detmold, Germany

University Hospitals Birmingham (UHB)

Birmingham, United Kingdom

Royal Blackburn Hospital

Blackburn, United Kingdom

Hull University Teaching Hospitals (HUTH)

Hull, United Kingdom

United Lincolnshire Hospitals (ULH)

Lincoln, United Kingdom

The Grange University Hospital, Newport

Newport, United Kingdom

Royal Albert Edward Infirmary

Wigan, United Kingdom