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ULTRA LONG: BioFreedom Ultra

StatusActive, Not Recruiting
PhaseNot applicable
Started2024-02-27
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 29, 2025 (before its estimated March 8, 2026 completion). Its status may not reflect the trial's current state.
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.

Amendment record

Amended 7 times since 2022-12-07; most recent filed 2025-06-25. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2025-06-25
Amendment Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v7
2025-01-28
Amendment Study Status, Oversight, Contacts/Locations v6
2024-11-04
Amendment Study Status v5
2024-06-12
Amendment Study Status, Contacts/Locations v4
2024-03-04
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
2023-10-11
Amendment Study Status v2
2023-07-17
Amendment Study Identification, Study Status, Study Design, Outcome Measures, Eligibility v1
2022-12-07
Original filing
Trial Details
NCT Number NCT05643430
Lead Sponsor Biosensors Europe SA
Conditions Coronary Artery Disease, High Bleeding Risk Patients
Enrollment 86 participants
Start Date 2024-02-27
Primary Completion 2026-03-08 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-06-29