NCT04918615

Compare Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter in De Novo Coronary Bifurcated Lesions

PROMISE-BIF ：A Prospective, Multicenter, Randomized Controlled Trial to Compare the Efficacy and Safety of Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter for the Treatment of De Novo Coronary Bifurcated Lesions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Microport sirolimus drug coated balloon catheter for the treatment of coronary bifurcation lesions.

Detailed description

PROMISE-BIF is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll about 234 participants. All participants will undergo PCI with sirolimus drug coated balloon catheter or paclitaxel drug coated balloon catheter and be followed-up to 24 months. The Target Lesion defined as the true bifurcation, include the main branch and side branch lesion. The bifurcation lesions were classified by Medina (1.1.1, 1.0.1, and 0.1.1). The image data will be analyzed and evaluated independently by a third-party imaging laboratory.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	PCI	Patients in experimental group will undergo PCI with drug coated balloon catheter to treat the side branch of the coronary bifurcation lesion.

Timeline

• Start date: 2021-02-28
• Primary completion: 2023-10-31
• Completion: 2024-12-31
• First posted: 2021-06-09
• Last updated: 2023-11-09

Locations

1 site across 1 country: China