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Study identifier: NCT06657326 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Coronary Artery Disease · Chronic Stable Angina · Unstable Angina  ·  Sponsor: Biosensors Europe SA

PhaseNA
Planned participants444
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Kar Imm Ang, MSc.  ·  +65 6213 0142  ·  ki.ang@biosensors.com

Always discuss trial participation with your own doctor first.

Locations (6)

Hospital Sultanah AminahJohor Bahru, Johor, MalaysiaRecruiting
Hospital Tengku Ampuan AfzanKuantan, Pahang, MalaysiaRecruiting
Hospital Raja Permaisuri BainunIpoh, Perak, MalaysiaRecruiting
Hospital Queen Elizabeth IIKota Kinabalu, Sabah, MalaysiaRecruiting
Pusat Jantung Hospital Umum SarawakKota Kinabalu, Sarawak, MalaysiaRecruiting
Hospital SerdangKajang, Selangor, MalaysiaRecruiting

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Source record: clinicaltrials.gov/study/NCT06657326