NCT06669793

Biolimus-Coated Balloon in de Novo Large Vessel Coronary Lesions

A Randomized Trial Comparing the Biolimus-coated Balloon and Paclitaxel-coated Balloon in de Novo Large Vessel Coronary Lesions

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 475 (estimated)
• Sponsor: Xuzhou Third People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Percutaneous coronary intervention (PCI) is one of the standard treatments for patients with acute and chronic coronary syndromes that are consistently recommended by current national and international guidelines. Currently, even with the most advanced design concepts of drug-eluting stents (DES), the permanent foreign body and in-stent restenosis after implantation are still very detrimental to the clinical outcomes of patients. These problems have been mitigated to some extent by the advent of the drug-coated balloon (DCB), a special balloon coated with an antiproliferative drug that is uniformly delivered to the vessel wall during endovascular dilatation to inhibit endothelial proliferation. This study is a prospective randomized study of a novel drug-coated balloon for the treatment of de novo coronary artery large vessel lesions. By comparing the clinical outcomes of the novel BA9 drug-coated balloon (BCB) with those of the paclitaxel-coated balloon (PCB) in the treatment of de novo coronary artery large vessel, we evaluated the safety and efficacy of the BCB for such lesions, and provided evidence for the later use of rapamycin-based drug-coated balloons in PCI. They are randomly dividing them into BCB treatment group and PCB treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after operation.

Conditions

• Coronary Arterial Disease (CAD)

Interventions

Type	Name	Description
DEVICE	biolimus-coated balloon	238 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of Biolimus-coated balloon.
DEVICE	paclitaxel-coated balloon	237 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of paclitaxel-coated balloon.

Timeline

• Start date: 2024-12-10
• Primary completion: 2027-05-23
• Completion: 2028-05-23
• First posted: 2024-11-01
• Last updated: 2024-11-01