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

NARecruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

December 20, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

March 31, 2027

Conditions
Coronary Bifurcation Lesion
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.

Trial Locations (1)

100034

RECRUITING

Peking University First Hospital, Beijing

Sponsors
All Listed Sponsors
collaborator

Peking University First Hospital

OTHER

lead

Dongguan TT Medical

INDUSTRY