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LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients

StatusRecruiting
PhaseNot applicable
Started2024-12-18
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 5, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™ DCS.

Amendment record

Amended 4 times since 2024-10-23; most recent filed 2025-06-03. 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 2026-08-30.

2025-06-03
Amendment Study Identification, Study Status, Oversight, Contacts/Locations v4
2025-03-06
Amendment Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v3
2024-12-12
Amendment Study Status, Eligibility, Contacts/Locations v2
2024-12-02
Amendment Study Status, Eligibility v1
2024-10-23
Original filing
Trial Details
NCT Number NCT06657326
Lead Sponsor Biosensors Europe SA
Conditions Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia, Acute Coronary Syndrome
Enrollment 444 participants
Start Date 2024-12-18
Primary Completion 2026-08 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-05