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NCT06657326 | NOT YET RECRUITING | Coronary Artery Disease

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

Biosensors Europe SA

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.

Condition or disease

Coronary Artery Disease

Chronic Stable Angina

Unstable Angina

Silent Ischemia

Acute Coronary Syndrome

Intervention/treatment

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

BioFreedom™ stainless steel Biolimus A9™-coated stent

Phase

NA

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
Estimated Enrollment : 444 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2030-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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. Patients requiring a planned staged PCI procedure more than one week after the index procedure
  • 6. Active bleeding at the time of inclusion
  • 7. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only).
  • 8. Number of target lesions \>2
  • 9. Patient requires a stent of diameter \<2.25mm
  • 10. Patient requires a stent of diameter \>4.0mm
  • 11. Lesions within 3 mm from the origin of LAD or LCx
  • 12. 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).
  • 13. Patient with chronic total occlusion(s) as target lesion(s)
  • 14. 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.
  • 15. Cardiogenic shock
  • 16. Compliance with long-term single anti-platelet therapy unlikely
  • 17. 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
  • 18. PCI during the previous 12 months for a lesion other than the target lesion
  • 19. Participation in another clinical study (12 months after index procedure)
  • 20. Patients with a life expectancy of \<12 months
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients

Location Details

NCT06657326

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Malaysia, Johor

Sultanah Aminah Hospital

Johor Bahru, Johor, Malaysia,

Not yet recruiting

Malaysia, Pahang

Tengku Ampuan Afzan Hospital

Kuantan, Pahang, Malaysia,

Not yet recruiting

Malaysia, Perak

King Queen Bainun Hospital

Ipoh, Perak, Malaysia,

Not yet recruiting

Malaysia, Sabah

Hospital Queen Elizabeth II

Kota Kinabalu, Sabah, Malaysia,

Not yet recruiting

Malaysia, Sarawak

Heart Center of Sarawak General Hospital

Kota Kinabalu, Sarawak, Malaysia,

Not yet recruiting

Malaysia, Selangor

Serdang Hospital

Kajang, Selangor, Malaysia,