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Compare Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter in De Novo Coronary Bifurcated Lesions — PROMISE-BIF  

Coronary Artery Disease Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04918615
Study type Interventional
Source Shanghai MicroPort Medical (Group) Co., Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date February 28, 2021
Completion date December 31, 2024
View Details
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