Comparing two types of drug-coated stents for patients at high bleeding risk

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 is testing if a new type of drug-coated stent is just as good and safe as a standard one for people with coronary artery disease who are at high risk of bleeding.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 444 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biosensors Europe SA (Industry-sponsored)
• Locations: 6 sites (Johor Bahru, Johor and 5 other locations)
• Trial ID: NCT06657326 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and safety of the BioFreedom™ Ultra Drug Coated Stent compared to the standard BioFreedom™ stent in patients with coronary artery disease who are at high bleeding risk. It is a prospective, multi-center, randomized trial involving 444 patients across several hospitals in Malaysia. The primary goal is to determine if the new stent is non-inferior in terms of late lumen loss after 9 months, while also assessing safety outcomes over a follow-up period of up to 5 years.

Who should consider this trial

Good fit: Ideal candidates are patients at high bleeding risk who require percutaneous coronary intervention and can tolerate dual antiplatelet therapy for at least one month.

Not a fit: Patients who are pregnant, under 18, or unable to provide informed consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer stenting option for patients at high bleeding risk, potentially improving their treatment outcomes.

How similar studies have performed: Previous studies have shown promise with drug-coated stents, but this specific comparison is novel.

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

Where this trial is running

Johor Bahru, Johor and 5 other locations

• 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)

Study contacts

• Principal investigator: Kamaraj a/l Selvaraj, Dr. — Hospital Serdang
• Study coordinator: Kar Imm Ang, MSc.

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