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

Launched by BIOSENSORS EUROPE SA · Oct 23, 2024

Keywords

ClinConnect Summary

The LEADERS FREE IV trial is studying two types of drug-coated stents, called BioFreedom™ Ultra and BioFreedom™, to see if the new BioFreedom™ Ultra stent is just as effective and safe for patients with coronary artery disease who are at high risk of bleeding. This trial is specifically looking at patients who have heart problems like stable angina, unstable angina, or other conditions related to acute coronary syndrome. To join the study, participants need to be between 65 and 74 years old and have a specific type of heart blockage that requires treatment with a stent.

Eligible patients will need to tolerate a month of dual antiplatelet therapy (DAPT), which means taking two different medications to prevent blood clots after getting the stent. However, there are certain criteria that might exclude individuals, such as being pregnant, under 18, or having specific medical conditions that could complicate the procedure. If you choose to participate, you will be monitored to ensure your safety and to see how well the stent works over time. This trial is currently recruiting participants, so now is the time to speak with your doctor if you think you might be eligible and interested in joining.

Gender

ALL

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