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

National Institute of Cardiology, Warsaw, Poland

Status: Enrolling

Conditions: Coronary Artery Disease; Total Occlusion of Coronary Artery

Treatments: Device: CTO PCI using DCB-only strategy

Study type: Observational

Funder types: Other

Identifiers

NCT05977842

CTO-DENOVO

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• de novo coronary CTO undergoing successful recanalization with the use of DCB-only strategy at the occlusion site

Exclusion criteria

• de novo coronary CTO undergoing successful recanalization with the use of DES at the occlusion site
• in-stent CTO