Clinical Trial

Sirolimus DEB in Coronary Bifurcation Lesions

Recruiting
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Record status
This record was last updated May 21, 2021 (before its estimated September 18, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT04896177
Lead Sponsor Shenzhen Salubris Pharmaceuticals Co., Ltd.
Conditions Coronary Bifurcation Lesions
Enrollment 280 participants
Start Date 2021-03-18
Primary Completion 2025-09-18 (estimated)
Study Completion 2026-09-18 (estimated)
Updated on ClinicalTrials.gov 2021-05-21