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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: ki.ang@biosensors.com
• Phone: +65 6213 0142

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.