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ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD
Sponsor: Biosensors Europe SA
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
Conditions
Interventions
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