NCT07162792

The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT

The Safety and Efficacy of New-Generation Bioabsorbable Scaffolds Versus Drug-Coated Balloons in the Treatment of De Novo Lesions in Large Coronary Arteries: A Prospective Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Xuzhou Third People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study plans to enroll 150 patients who are candidates for "intervention without implantation" therapy and they will be randomly assigned in a 1:1 ratio to either the new-generation Firesorb scaffold group (BRS group, N=75) or the drug-coated balloon group (DCB group, N=75). All enrolled patients will undergo angiographic follow-up at 1 year post-procedure, and serial follow-up (via telephone or outpatient visit) will be performed at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure. The primary study endpoint was percentage diameter stenosis at 1 year post-procedure.

Conditions

• Coronary Artery Disease(CAD)
• de Novo Coronary Lesions

Interventions

Type	Name	Description
DEVICE	bioresorbable scaffold	75 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of BRS.
DEVICE	drug-coated balloon	75 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of DCB.

Timeline

• Start date: 2025-10-23
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2025-09-09
• Last updated: 2025-09-09