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NOT YET RECRUITING
NCT07582250
NA

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

Sponsor: JW Medical Systems Ltd

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1548

Start Date

2026-06

Completion Date

2030-12

Last Updated

2026-05-12

Healthy Volunteers

No

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.