NCT05750771

Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD

Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Henan Institute of Cardiovascular Epidemiology · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries. And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	DES	Second-generation drug-eluting stents
DEVICE	DCB	Drug-coated balloon with paclitaxel as drug coating

Timeline

• Start date: 2023-02-20
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2023-03-02
• Last updated: 2026-04-06

Locations

1 site across 1 country: China