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RECRUITING
NCT06822712
NA

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

Sponsor: BrosMed Medical Co., Ltd

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-03-03

Completion Date

2026-06

Last Updated

2025-09-17

Healthy Volunteers

No

Interventions

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

Locations (1)

The First Hospital of Lanzhou University

Lanzhou, Gansu, China