NCT05101005

Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions

A Prospective, Multi-center, Randomized Trial Comparing the Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75\~4.0mm).

Detailed description

Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.

Conditions

• Coronary Artery Disease
• Drug-coated Balloon

Interventions

Type	Name	Description
DEVICE	Drug-Coated Balloon	Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions.
DEVICE	Sirolimus-Eluting Stent	Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2021-10-29
• Last updated: 2021-10-29