NCT06618248

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Dongguan TT Medical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, randomized controlled, non-inferiority trial conducted across 13-20 sites. The study aims to enroll 280 patients with true coronary bifurcation lesions in native coronary arteries. Eligible patients will be randomized in a 1:1 ratio to receive either the Sirolimus-coated spiral balloon (SuperFlow®) or the Paclitaxel-coated balloon (Bingo™), following a site-specific blocked randomization schedule. All participants will be screened based on the trial's predefined inclusion and exclusion criteria. Data and imaging will be collected during the index procedure and at the predefined 9-month clinical follow-up visit.

Conditions

• Coronary Bifurcation Lesion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-20
• Primary completion: 2025-09-01
• Completion: 2027-03-01
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: China