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

NCT06657326 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2025-06-05

No results posted yet for this study

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

Interventions

DEVICE

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

Stent implantation

DEVICE

BioFreedom™ stainless steel Biolimus A9™-coated stent

Stent implantation

Sponsors & Collaborators

  • Biosensors Europe SA

    lead INDUSTRY

Principal Investigators

  • Kamaraj a/l Selvaraj, Dr. · Hospital Serdang

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-18
Primary Completion
2026-08-31
Completion
2030-12-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06657326 on ClinicalTrials.gov