A Prospective, Multi-center, Randomized Trial Comparing the Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions

Lepu Medical Technology (Beijing) Co., Ltd.0 sites400 target enrollmentOctober 2021

ConditionsCoronary Artery Disease Drug-coated Balloon

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Enrollment: 400
Primary Endpoint: Target lesion failure
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75~4.0mm).

Detailed Description

Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.

Registry

clinicaltrials.gov

Start Date

October 2021

End Date

November 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lepu Medical Technology (Beijing) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years and ≤80 years, regardless of gender;
•De novo lesion in a native coronary artery;
•Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia;
•Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and TIMI flow ≥1;
•The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting);
•The subject who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and is willing to accept clinical follow-up.

Exclusion Criteria

•Reference vessel diameter \<2.75 mm or \>4.0 mm;
•In stent restenosis;
•Left main lesion, chronic complete occlusion lesion;
•Ostial lesion ≤2mm from the LM, or bifurcation lesion with branch vessel diameter≥2.5mm;
•There is a large scale of thrombus in the target vessel, and the thrombus grade \>3 after thrombolysis or aspiration;
•Severe heart failure (NYHA IV);
•Severe renal failure (GFR\<30ml/min) or undergoing hemodialysis treatment;
•Severe liver failure (bilirubin is over 2 times the upper limit of normal, or alanine aminotransferase is over 3 times the upper limit of normal);
•Patients with vein graft restenosis after bypass or severe heart valve disease;
•Pregnant or breastfeeding female patients;