NCT06657326View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

444

Participants

Timeline

Start Date

December 18, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

December 31, 2030

Conditions
Coronary Artery DiseaseChronic Stable AnginaUnstable AnginaSilent IschemiaAcute Coronary Syndrome
Interventions
DEVICE

BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent

Stent implantation

DEVICE

BioFreedom™ stainless steel Biolimus A9™-coated stent

Stent implantation

Trial Locations (6)

Unknown

RECRUITING

Hospital Sultanah Aminah, Johor Bahru

RECRUITING

Hospital Tengku Ampuan Afzan, Kuantan

RECRUITING

Hospital Raja Permaisuri Bainun, Ipoh

RECRUITING

Hospital Queen Elizabeth II, Kota Kinabalu

RECRUITING

Pusat Jantung Hospital Umum Sarawak, Kota Kinabalu

RECRUITING

Hospital Serdang, Kajang

All Listed Sponsors
lead

Biosensors Europe SA

INDUSTRY