The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk of bleeding (HBR). The main question it aims to answer is to evaluate if the additional sizes of the BioFreedom Ultra have corresponding clinical safety and efficacy characteristics as the regulatory approved (=CE Marked) sizes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
The BioFreedom Ultra CoCr DCS is a combination product consisting of two key components: the cobalt chromium stent platform coated abluminally with the active ingredient BA9TM (polymer and carrier free) and the delivery system.
Cardiovascular Institute Paris Sud (ICPS) L'Hôpital Privé Jacques Cartier
Massy, Massy, France
Arnault Institute Tzanck
Saint-Laurent-du-Var, Saint-Laurent-du-Var, France
Pôle Santé République
Clermont-Ferrand, France
TLF
Incidence of Target Lesion Failure, clinically-driven target lesion revascularization (cd-TLR), Cardiovascular Death and TV-MI
Time frame: at 9 months after index procedure
CD-TLR
Incidence of Clinically driven Target Lesion Revascularization
Time frame: Clinical endpoints measured at 9 and 24 months
Cardiovascular Death
Incidence
Time frame: Clinical endpoints measured at 9 and 24 months
TV-MI
Target-Vessel Myocardial Infarction
Time frame: Clinical endpoints measured at 9 and 24 months
TVR
Target Vessel Revascularization
Time frame: Clinical endpoints measured at 9 and 24 months
Stent thrombosis rate - definite/probable
Incidence
Time frame: Clinical endpoints measured at 9 and 24 months
All cause mortality
Incidence
Time frame: Clinical endpoints measured at 9 and 24 months
Bleeding rate (BARC 2-5)
Incidence of BARC 2-5
Time frame: Clinical endpoints measured at 9 and 24 months
Peri-procedural endpoints
Incidence of Device success; Lesion success and Procedure success
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: Peri-procedural endpoints measured at 9 and 24 months