NCT06822712

Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions

A Prospective, Multicenter, Noninferiority, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated Balloon Catheter for the Treatment of De Novo Coronary Bifurcation Lesions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: BrosMed Medical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated balloon catheter for the Treatment of De Novo Coronary Bifurcation Lesions

Conditions

• Coronary Arterial Disease (CAD)

Interventions

Type	Name	Description
DEVICE	Sirolimus-coated Balloon Dilatation Catheter	During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Sirolimus-coated Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure
DEVICE	Paclitaxel-coated Balloon Dilatation Catheter	During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Paclitaxel-coated Balloon Dilatation Catheter in the control group, subsequently completing the remaining procedure

Timeline

• Start date: 2025-03-03
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-02-12
• Last updated: 2025-09-17

Locations

1 site across 1 country: China