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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
Sponsor: JW Medical Systems Ltd
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
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.
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.