ULTRA LONG: BioFreedom Ultra

Not Applicable

Recruiting

• Conditions: High Bleeding Risk Patients; Coronary Artery Disease
• Interventions: Device: BioFreedom Ultra

• Registration Number: NCT05643430
• Lead Sponsor: Biosensors Europe SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-08
• Study Start: 2024-02-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-03-08
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

1. Pregnant and breastfeeding women
2. Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
3. Patients not expected to comply with 1 month of DAPT
4. Staged procedures in the target vessel
5. Active bleeding at the time of inclusion
6. Cardiogenic shock
7. Unlikely compliance with long-term single anti-platelet therapy
8. 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
9. Currently participating in another trial before reaching primary endpoint
10. Patients under judicial protection, tutorship or curatorship (France only)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BioFreedom Ultra	BioFreedom Ultra	All patients will receive the BioFreedom Ultra as per treatment.

Primary Outcome Measures

Name	Time	Method
TLF	at 9 months after index procedure	Incidence of Target Lesion Failure, clinically-driven target lesion revascularization (cd-TLR), Cardiovascular Death and TV-MI

Secondary Outcome Measures

Name	Time	Method
Stent thrombosis rate - definite/probable	Clinical endpoints measured at 9 and 24 months	Incidence
CD-TLR	Clinical endpoints measured at 9 and 24 months	Incidence of Clinically driven Target Lesion Revascularization
Bleeding rate (BARC 2-5)	Clinical endpoints measured at 9 and 24 months	Incidence of BARC 2-5
Cardiovascular Death	Clinical endpoints measured at 9 and 24 months	Incidence
TVR	Clinical endpoints measured at 9 and 24 months	Target Vessel Revascularization
Peri-procedural endpoints	Peri-procedural endpoints measured at 9 and 24 months	Incidence of Device success; Lesion success and Procedure success
TV-MI	Clinical endpoints measured at 9 and 24 months	Target-Vessel Myocardial Infarction
All cause mortality	Clinical endpoints measured at 9 and 24 months	Incidence

Trial Locations

Locations (9)

University Hospitals Birmingham (UHB); 🇬🇧 Birmingham, United Kingdom

Royal Blackburn Hospital; 🇬🇧 Blackburn, United Kingdom

Royal Albert Edward Infirmary; 🇬🇧 Wigan, United Kingdom

Arnault Institute Tzanck; 🇫🇷 Saint-Laurent-du-Var, France

United Lincolnshire Hospitals (ULH); 🇬🇧 Lincoln, United Kingdom

The Grange University Hospital, Newport; 🇬🇧 Newport, United Kingdom

Hull University Teaching Hospitals (HUTH); 🇬🇧 Hull, United Kingdom

Pôle Santé République; 🇫🇷 Clermont-Ferrand, France

Cardiovascular Institute Paris Sud (ICPS) L'Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France