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RECRUITING
NCT06618248
NA

Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions

Sponsor: Dongguan TT Medical

View on ClinicalTrials.gov

Summary

This is a multicenter, prospective randomized controlled study to evaluate the safety and effectiveness of Sirolimus-coated spiral balloon (SuperFlow®) versus Paclitaxel-coated balloon (Bingo™) in the treatment of coronary bifurcation lesions.

Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Sirolimus-coated Spiral Balloon Catheter for the Treatment of Coronary Bifurcation Lesions

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2023-12-20

Completion Date

2027-03

Last Updated

2024-10-01

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Sirolimus coated balloon angioplasty

This study involves the use of a Sirolimus-Coated Balloon (SCB) for the treatment of coronary artery disease, specifically targeting coronary bifurcation lesions. The SCB is coated with sirolimus, an antiproliferative drug that helps to prevent restenosis by inhibiting smooth muscle cell proliferation. The balloon is inflated at the target lesion site, delivering the drug directly to the arterial wall. This intervention aims to achieve vessel dilation while reducing the risk of restenosis, providing a potential alternative to stent placement.

COMBINATION_PRODUCT

Paclitaxel coated balloon angioplasty

This study involves the use of a Paclitaxel-Coated Balloon (PCB) for the treatment of coronary artery disease, specifically targeting coronary bifurcation lesions. The PCB is coated with paclitaxel, an antiproliferative drug that helps to prevent restenosis by inhibiting smooth muscle cell proliferation. The balloon is inflated at the target lesion site, delivering the drug directly to the arterial wall. This intervention aims to achieve vessel dilation while reducing the risk of restenosis, providing a potential alternative to stent placement.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China