Sirolimus DEB in Coronary Bifurcation Lesions

Coronary Bifurcation Lesions Clinical Trial

Official title:
A Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Trial to Evaluate the Efficacy and Safety of Sirolimus Drug-eluting Coronary Balloon Catheter in Treatment of Coronary Bifurcation Lesions

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions. This is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.

Clinical Trial Description

The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions. This is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants with would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months. ;

Study Design

Related Conditions & MeSH terms

Coronary Bifurcation Lesions

Clinical Trial Details

NCT number	NCT04896177
Study type	Interventional
Source	Shenzhen Salubris Pharmaceuticals Co., Ltd.
Contact	Wei Huang, Dr.
Phone	+86 83867888
Email	huangwei01@salubris.com
Status	Recruiting
Phase	N/A
Start date	March 18, 2021
Completion date	September 18, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04899583` - ACOART SCB BIF: Treatment of Coronary Bifurcation Lesion by Sirolimus Coated Balloon vs Paclitaxel Coated Balloon	N/A
Withdrawn	`NCT02384629` - PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease	Phase 4
Completed	`NCT03027830` - iFR Pressure Wires in Assessment of the Provisional Side-branch Intervention Strategy for Bifurcation Lesions	N/A
Completed	`NCT03172845` - Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions	N/A
Active, not recruiting	`NCT02928198` - Bifurcation ABSORB OCT Trial	N/A
Completed	`NCT01538186` - Treatment Of Coronary Bifurcation Lesions: Stentcovering Of The Side Branch With And Without PCI Of The Side Branch: A Retrospective Analysis Of All Consecutive Patients	N/A
Recruiting	`NCT05100992` - Progress Bifurcation Global Registry