NCT05550233

Drug-coated Balloons in Big de Novo Coronary Disease

A Prospective, Multicentric, Randomized Controlled Clinical Trial of Drug-coated Balloons in the Treatment of Big de Novo Coronary Artery Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter, randomized controlled, open-label, non-inferiority trial. Plan to recruit 240 patients whose lesions are de novo coronary artery disease (reference vessel diameter ≥ 3.0 mm), diameter stenosis ≥ 75% with ischemic symptoms or objective evidence of ischemia (ECG, cardionuclide, or FFR), and are suitable for implantation DES or DCB. After successful preconditioning, patients were randomly assigned to two PCI treatment groups(drug-coated balloon or drug-eluted stent) in a 1:1 ratio. The safety and efficacy of drug-coated balloons in PCI treatment of de novo coronary artery lesions (reference diameter 3.0 mm and above) were evaluated by comparing the late lumen loss of two groups of subjects in 12 months.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	drug-coated balloon	drug-coated balloon in big de novo coronary disease

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-09-22
• Last updated: 2023-02-08

Locations

1 site across 1 country: China