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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Patient will be treated with BioMatrix Alpha
Klinikum Bielefeld
Bielefeld, Germany
Krankenhaus Buchholz
Buchholz, Germany
Klinikum Lippe GmbH
Detmold, Germany
University Hospitals Birmingham (UHB)
Birmingham, United Kingdom
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)
Time frame: at 9 months after index procedure
Number of participants with Cardiovascular Death (CD)
Incidence
Time frame: at 9 months after index procedure
Number of participants with Target Vessel Myocardial Infarction
Target Vessel Myocardial Infarction (TV-MI)
Time frame: at 9 months after index procedure
Number of participants with Clinically indicated Target Lesion Revascularization
Clinically indicated Target Lesion Revascularization (ci-TLR)
Time frame: at 9 months after index procedure
Number of participants with Target Vessel Revascularization
Target Vessel Revascularization (TVR)
Time frame: at 9 months after index procedure
Number of participants with Stent thrombosis (definite and/or probable)
incidence
Time frame: at 9 months after index procedure
Number of of participants with All-cause mortality
incidence
Time frame: at 9 months after index procedure
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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