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
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
• Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.
Locations
Other Locations
Malaysia
Hospital Raja Permaisuri Bainun
RECRUITING
Ipoh
Hospital Sultanah Aminah
RECRUITING
Johor Bahru
Hospital Serdang
RECRUITING
Kajang
Hospital Queen Elizabeth II
RECRUITING
Kota Kinabalu
Pusat Jantung Hospital Umum Sarawak
RECRUITING
Kota Kinabalu
Hospital Tengku Ampuan Afzan
RECRUITING
Kuantan
Contact Information
Primary
Kar Imm Ang, MSc.
ki.ang@biosensors.com
+65 6213 0142
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2030-12
Participants
Target number of participants: 444
Treatments
Experimental: BioFreedom™ Ultra DCS
Coronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ Ultra stent if randomized to this arm (1:1 ratio)
Active_comparator: BioFreedom™ DCS
Coronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ stent if randomized to this arm (1:1 ratio)
Related Therapeutic Areas
Sponsors
Leads: Biosensors Europe SA