NCT05846893

Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

Randomised Trial of Drug-Coated Balloon Versus Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,436 (estimated)
• Sponsor: B. Braun Medical Industries Sdn. Bhd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.

Detailed description

Although several reports suggested that DCB application was safe for larger coronary artery lesions and showed good long-term outcomes, there is limited randomised controlled trial (RCT) data on the safety and efficacy of DCB in large coronary artery disease. Therefore, the study aims to demonstrate the non-inferiority of the drug-coated balloon (DCB) treatment against current-generation drug-eluting stenting (DES) in patients with de novo lesions in large coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation). The hypothesis of the study is the clinical outcomes of patients treated with DCB are non-inferior to those treated with current-generation DES.

Conditions

• Coronary Artery Disease
• Myocardial Ischemia
• Acute Coronary Syndrome
• Coronary Stenosis
• De Novo Stenosis

Interventions

Type	Name	Description
DEVICE	SeQuent® Please NEO drug-coated balloon catheter	Treatment of coronary artery disease with SeQuent® Please NEO for de novo lesions in native large coronary arteries
DEVICE	Current-generation drug-eluting stent	Treatment of coronary artery disease with current-generation drug-eluting stent for de novo lesions in native large coronary arteries

Timeline

• Start date: 2023-09-07
• Primary completion: 2026-10-01
• Completion: 2028-09-01
• First posted: 2023-05-06
• Last updated: 2024-11-05

Locations

19 sites across 4 countries: Malaysia, Singapore, South Korea, Taiwan