NCT05977842

Drug-coated Balloon in de Novo Chronic Total Occlusions

Drug-coated Balloon in de Novo Chronic Total Occlusions (CTO-DENOVO Registry)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 309 (actual)
• Sponsor: National Institute of Cardiology, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CTO-DENOVO study is a multicenter registry of consecutive patients with de novo coronary chronic total occlusions (CTO) undergoing successful CTO recanalization with the use of drug-coated balloon (DCB)-only strategy. The primary endpoint is target lesion failure at 6 months. The secondary endpoints are: 1) late lumen loss on follow-up angiography, and 2) minimal lumen area on follow-up intravascular ultrasound.

Conditions

• Coronary Artery Disease
• Total Occlusion of Coronary Artery

Interventions

Type	Name	Description
DEVICE	CTO PCI using DCB-only strategy	Successful CTO recanalization treated with DCB at the occlusion site

Timeline

• Start date: 2012-12-15
• Primary completion: 2024-12-15
• Completion: 2025-01-01
• First posted: 2023-08-07
• Last updated: 2026-01-02

Locations

35 sites across 12 countries: Austria, Belgium, Croatia, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Romania, Spain