NCT06657326

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

Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Ultra Drug Coated Stent in Patients With High Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 444 (estimated)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The LEADERS FREE IV trial is conducted to evaluate of the efficacy (QCA) and safety of the BioFreedom™ Ultra Drug Coated Stent in patients with High Bleeding Risk (HBR) and coronary artery disease undergoing Percutaneous Coronary Intervention. It is a prospective, multi-center, single blind (to patient), randomized, comparator trial, designed to randomize 444 HBR patients at approximately up to 7 centers in Malaysia. The primary objective is to confirm non-inferiority of the BioFreedom™ Ultra stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary objective is to assess safety as measured by TLF and ST. 444 patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed up to 5 years to measure for late TLF and ST events.

Conditions

• Coronary Artery Disease
• Chronic Stable Angina
• Unstable Angina
• Silent Ischemia
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent	Stent implantation
DEVICE	BioFreedom™ stainless steel Biolimus A9™-coated stent	Stent implantation

Timeline

• Start date: 2024-12-18
• Primary completion: 2026-08-01
• Completion: 2030-12-01
• First posted: 2024-10-24
• Last updated: 2025-06-05

Locations

6 sites across 1 country: Malaysia