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A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions

NCT07582250 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1548

Last updated 2026-05-12

No results posted yet for this study

Summary

To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions.

Conditions

  • Patients With de Novo Coronary Artery Lesions

Interventions

DEVICE

Biolimus-Coated Coronary Artery Balloon Dilatation Catheter

A total of 774 subjects meeting the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Biolimus-Coated Coronary Artery Balloon Dilatation Catheter.

DEVICE

Xinyue Drug-Coated Stent System

A total of 774 eligible subjects who met the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Excrossal™ Xinyue Drug-Coated Stent System.

Sponsors & Collaborators

  • JW Medical Systems Ltd

    lead INDUSTRY

Principal Investigators

  • Bin Liu · Second Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-06-30
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07582250 on ClinicalTrials.gov