A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System

Biosensors Europe SA9 sites in 2 countries86 target enrollmentFebruary 27, 2024

ConditionsCoronary Artery Disease High Bleeding Risk Patients

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Biosensors Europe SA
Enrollment: 86
Locations: 9
Primary Endpoint: TLF
Status: Active, Not Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 27, 2024

End Date

August 31, 2026

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biosensors Europe SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Pregnant and breastfeeding women
•Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
•Patients not expected to comply with 1 month of DAPT
•Staged procedures in the target vessel
•Active bleeding at the time of inclusion
•Cardiogenic shock
•Unlikely compliance with long-term single anti-platelet therapy
•Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated
•Currently participating in another trial before reaching primary endpoint
•Patients under judicial protection, tutorship or curatorship (France only)

Outcomes

Primary Outcomes

TLF

Time Frame: at 9 months after index procedure

Incidence of Target Lesion Failure, clinically-driven target lesion revascularization (cd-TLR), Cardiovascular Death and TV-MI

Secondary Outcomes

CD-TLR(Clinical endpoints measured at 9 and 24 months)
Bleeding rate (BARC 2-5)(Clinical endpoints measured at 9 and 24 months)
Cardiovascular Death(Clinical endpoints measured at 9 and 24 months)
TVR(Clinical endpoints measured at 9 and 24 months)
Stent thrombosis rate - definite/probable(Clinical endpoints measured at 9 and 24 months)
Peri-procedural endpoints(Peri-procedural endpoints measured at 9 and 24 months)
TV-MI(Clinical endpoints measured at 9 and 24 months)
All cause mortality(Clinical endpoints measured at 9 and 24 months)