NCT04664283

Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography：a Prospective Multi-center Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Liu Bin · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.

Conditions

• Angioplasty
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography	DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-12-11
• Last updated: 2020-12-11

Locations

2 sites across 1 country: China