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

NCT06657326 | Recruiting DMC

• 1 other identifier: 24-AP-01
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss (LLL) at 9 months

  In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months

  9 months

Secondary Outcomes (1)

• All clinical events at protocol defined timepoints

  1,6,9,12 months, 2 ,3, 4, 5 years

Study Arms (2)

BioFreedom™ Ultra DCS

EXPERIMENTAL

Coronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ Ultra stent if randomized to this arm (1:1 ratio)

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

BioFreedom™ DCS

ACTIVE COMPARATOR

Coronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ stent if randomized to this arm (1:1 ratio)

Device: BioFreedom™ stainless steel Biolimus A9™-coated stent

Interventions

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

Stent implantation

BioFreedom™ Ultra DCS

BioFreedom™ stainless steel Biolimus A9™-coated stent DEVICE

Stent implantation

BioFreedom™ DCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at high bleeding risk (HBR) with an indication for PCI who can tolerate at least one month of DAPT. This includes patients with stable angina, silent ischemia, acute coronary syndromes (ACS) (STEMI and NSTEMI), de novo lesions in native arteries with diameter stenosis \>70% by visual estimation and evidence of ischemia in the territory of the target vessel(s).
• Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.

You may not qualify if:

• Pregnant and breastfeeding women
• Age \<18 years old
• Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
• Patients expected not to comply with 1 month DAPT
• Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only)
• Number of target lesions \>2
• Patient requires a stent of diameter \<2.25mm
• Patient requires a stent of diameter \>4.0mm
• Isolated ostial lesions within 3 mm of the origin of LAD or LCx (left main lesions involving the ostia of the LAD and/or LCx are eligible)
• Patient has known left ventricular ejection fraction (LVEF) \<30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary)
• Patient with chronic total occlusion(s) as target lesion(s)
• Severe calcification that might prevent sufficient expansion of the DES, unless pre-treated with a plaque modification device such as cutting balloon, scoring balloon or intravascular lithotripsy.
• Note: Use of rotational or orbital atherectomy is also permitted.
• Cardiogenic shock
• Compliance with long-term single anti-platelet therapy unlikely

Sponsors & Collaborators

• Biosensors Europe SA: lead

Study Sites (6)

Hospital Sultanah Aminah

Johor Bahru, Johor, Malaysia

RECRUITING

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, Malaysia

RECRUITING

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

RECRUITING

Hospital Queen Elizabeth II

Kota Kinabalu, Sabah, Malaysia

RECRUITING

Pusat Jantung Hospital Umum Sarawak

Kota Kinabalu, Sarawak, Malaysia

RECRUITING

Hospital Serdang

Kajang, Selangor, Malaysia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Angina, Unstable; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kamaraj a/l Selvaraj, Dr.

  Hospital Serdang

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kar Imm Ang, MSc.

CONTACT

+65 6213 0142; ki.ang@biosensors.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patient will be randomized to one of the treatment arms to receive either the BioFreedom™ Ultra DCS or BioFreedom™ DCS

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (6)