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

Shenzhen Salubris Pharmaceuticals Co., Ltd.1 site in 1 country280 target enrollmentMarch 18, 2021

ConditionsCoronary Bifurcation Lesions

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Bifurcation Lesions
Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Enrollment: 280
Locations: 1
Primary Endpoint: Stenosis of lumen diameter of target lesion branch
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

March 18, 2021

End Date

September 18, 2026

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or Female that ages 18-85 year old;
•Having evidence of myocardial ischemia;
•Voluntarily participates in this study and signs the informed consent form (ICF);
•Sufficiently compliant with the study protocol and agreed to receive follow-up at 1 month ±7 days, 6 months ±14 days, 9 months ±30 days, 12 months ±30 days, and 24 months ±30 days, of which angiography was required at 9 months ±30 days;
•Angiography confirmed as de novo bifurcation lesion with side-branch stenosis (diameter) ≥70%;
•Suitable for PCI and side-branch lesions are not expected to stent implantation, and no drug-eluting balloon used for the main-branch. If a stent is implanted into the main-branch, it's usually necessary to perform a final balloon kissing on the two branches;
•Residual stenosis of the side-branch lesion ≦50% after pre-treatment, with a TIMI flow grade 3;
•The target vessel diameter was 2.0mm-4.0mm.

Exclusion Criteria

•Women who is pregnant or lactating, or having a fertility plan within 1 year or are unwilling to take effective contraceptive measures;
•Cardiogenic shock patients;
•With hemorrhagic symptoms or active gastrointestinal ulcers, or previous stroke within 6 months, or who are expected to be unable to tolerate double-antibody therapy after interventional therapy;
•ST-segment elevation myocardial infarction (STEMI) occurred within one week before enrollment;
•With severe congestive heart failure or NYHA class Ⅳ heart failure;
•With severe valvuar heart disease;
•Heart transplant patients;
•With renal insufficiency (creatinine \> 3.0mg/ dL or 265.2 umol /L) and/or advanced renal disease requiring dialysis;
•With a life expectancy less than 1 year;
•With contraindications who cannot take aspirin and/or clopidogrel and/or ticagrelor;

Outcomes

Primary Outcomes

Stenosis of lumen diameter of target lesion branch

Time Frame: 9 months (±30 days)

The degree of lumen diameter stenosis (%) =(1- the minimum lumen diameter of the vessel/the reference diameter of the target lesion vessel)×100%

Secondary Outcomes

Success rate of interventional treatment(Index Procedure)
Target lesion failure rate (TLF)(1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days))
Late lumen loss (LLL)(9 months (±30 days))
Incidence of restenosis of target lesions(9 months (±30 days))
Target vessel revascularization (TVR)(1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days))
Target lesions revascularization (TLR)(1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days))