Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions

The aim of this study is to evaluate the long-term efficacy and safety of drug-coated balloon (DCB) strategies, including DCB alone or hybrid strategies of DCB and drug-eluting stent (DES), compared to DES-only in patients with chronic total occlusion (CTO) after successful recanalization. Through a prospective, multicenter randomized controlled trial, we will directly compare the long-term outcomes of these two treatment strategies in CTO patients to fill the gap in existing research regarding direct comparative data between DCB and DES in CTO treatment. This study expects to provide high-quality evidence for optimizing CTO treatment, potentially improving treatment strategies in complex cases, reducing stent usage, lowering the risk of complications, and ultimately enhancing patient prognosis.

NCT Number	NCT07463664
Lead Sponsor	The First Affiliated Hospital of Zhengzhou University
Conditions	Chronic Total Occlusions of Coronary Arteries, Chronic Total Occlusion (CTO), Coronary Artery Disease (CAD)
Enrollment	200 participants
Start Date	2025-04-28
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-11