Clinical trial NCT06657326: LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Chronic Stable Angina
Unstable Angina
Silent Ischemia
Acute Coronary Syndrome
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient will be randomized to one of the treatment arms to receive either the BioFreedom™ Ultra DCS or BioFreedom™ DCS
Primary purpose: TREATMENT

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.

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.

Eligibility 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. 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

Primary outcomes:
measure: In-stent late lumen loss (LLL) at 9 months
timeFrame: 9 months
Secondary outcomes:
measure: All clinical events at protocol defined timepoints
timeFrame: 1,6,9,12 months, 2 ,3, 4, 5 years
Other outcomes:
Locations:
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
state: Johor
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
state: Pahang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth II
state: Sabah
city: Kota Kinabalu
country: Malaysia
facility: Pusat Jantung Hospital Umum Sarawak
state: Sarawak
city: Kajang
country: Malaysia
facility: Hospital Serdang
state: Selangor
Study officials:
affiliation: Hospital Serdang
name: Kamaraj a/l Selvaraj, Dr.
role: PRINCIPAL_INVESTIGATOR
References: