A Prospective, Multicenter, Random Controlled Clinical Trail to Evaluate the Effectiveness and Safety of Sirolimus Coated Balloon Versus a Paclitaxel Coated Balloon in the Treatment of Coronary Bifurcation Lesion

Acotec Scientific Co., Ltd1 site in 1 country230 target enrollmentNovember 10, 2021

ConditionsCoronary Bifurcation Lesions

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Bifurcation Lesions
Sponsor: Acotec Scientific Co., Ltd
Enrollment: 230
Locations: 1
Primary Endpoint: Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure.
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this randomized controlled trial is to examine the treatment of coronary bifurcation lesion with a sirolimus coated balloon versus a paclitaxel coated balloon. This trial is designed as prospective, multicenter, randomized and open-label.

Registry

clinicaltrials.gov

Start Date

November 10, 2021

End Date

November 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Acotec Scientific Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old and ≤75 years old
•Diagnosed as stable or unstable angina pectoris, asymptomatic myocardial ischemia or old myocardial infarction, or recent myocardial infarction in stable stage.
•Eligible for balloon dilatation or stent implantation.
•Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed

Exclusion Criteria

•AMI occurred within 7 days before operation
•The subjects had congestive heart failure or the heart function was classified as NYHA/KillipIV.
•Left ventricular ejection fraction (LVEF) \< 35%
•History of heart transplantation
•The subjects had severe arrhythmias, such as high-risk ventricular extrasystole and / or ventricular tachycardia.
•The subjects had stroke, gastrointestinal bleeding or active ulcers, or had a high risk of bleeding in the past 6 months.
•Active bleeding physique or blood coagulation disorder
•Known renal insufficiency（eGFR\<30ml/min）
•Contraindicated to anticoagulants or antiplatelet agents
•Has a history of percutaneous coronary intervention (PCI) within 6 months before enrollment.

Outcomes

Primary Outcomes

Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure.

Time Frame: 9 months post procedure

Defined as (1-minimum lumen diameter of target lesion/reference vessel diameter)\*100% at 9 months post procedure.

Secondary Outcomes

Diameter stenosis rate(9 months post procedure)
Rate of procedure success(Immediately after procedure)
Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE）(30 days, 6 months, 9 months, 12 months post procedure)
Rate of device success(Immediately after procedure)
Rate of lesion success(Immediately after procedure)
Late lumen loss (LLL)(9 months post procedure)
Angiographic binary restenosis (ABR) rate(9 months post procedure)
Rate of patient-related composite endpoints (PoCE）(30 days, 6 months, 9 months, 12 months post procedure)
Rate of composite safety endpoint(12 months post procedure)