Sirolimus DEB in Coronary Bifurcation Lesions

StatusUnknown
PhaseNot applicable
Started

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.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since May 2021); last known: Recruiting
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)		 Coronary Bifurcation Lesions
Related terms Coronary Disease
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov