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

June 3, 2025 updated by: Biosensors Europe SA

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

444

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Johor
      • Johor Bahru, Johor, Malaysia
        • Recruiting
        • Hospital Sultanah Aminah
        • Contact:
    • Pahang
      • Kuantan, Pahang, Malaysia
        • Recruiting
        • Hospital Tengku Ampuan Afzan
        • Contact:
    • Perak
      • Ipoh, Perak, Malaysia
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia
        • Recruiting
        • Hospital Queen Elizabeth II
        • Contact:
    • Sarawak
      • Kota Kinabalu, Sarawak, Malaysia
        • Recruiting
        • Pusat Jantung Hospital Umum Sarawak
        • Contact:
    • Selangor
      • Kajang, Selangor, Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.

Exclusion Criteria:

  1. Pregnant and breastfeeding women
  2. Age <18 years old
  3. Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
  4. Patients expected not to comply with 1 month DAPT
  5. Active bleeding at the time of inclusion
  6. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only)
  7. Number of target lesions >2
  8. Patient requires a stent of diameter <2.25mm
  9. Patient requires a stent of diameter >4.0mm
  10. 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)
  11. 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)
  12. Patient with chronic total occlusion(s) as target lesion(s)

  13. 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.

  14. Cardiogenic shock
  15. Compliance with long-term single anti-platelet therapy unlikely
  16. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated
  17. Any PCI during the previous 12 months
  18. Participation in another clinical study (12 months after index procedure)
  19. Patients with a life expectancy of <12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BioFreedom™ Ultra DCS
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
Stent implantation
Active Comparator: BioFreedom™ DCS
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
Stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-stent late lumen loss (LLL) at 9 months
Time Frame: 9 months
In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All clinical events at protocol defined timepoints
Time Frame: 1,6,9,12 months, 2 ,3, 4, 5 years
  • Cardiovascular Death
  • Myocardial infarction (according to the Fourth Universal Definition)
  • TLF (defined as cardiovascular death, target vessel related MI and clinically driven (cd) target lesion revascularization (TLR))
  • All-cause mortality
  • Clinically driven TVR
  • Stent Thrombosis, per ARC-2 definition of definite/probable
  • Device success
  • Procedure success
  • Lesion success

  • Bleeding per BARC criteria

    • BARC 3 to 5
    • All BARC
    • By vascular access site (Femoral/Radial)
1,6,9,12 months, 2 ,3, 4, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosensors Europe SA

Investigators

  • Principal Investigator: Kamaraj a/l Selvaraj, Dr., Hospital Serdang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-AP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data relating to the study might be made available to third parties provided the data are treated confidential and that the patient's privacy is guaranteed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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