Drug-coated Balloon in de Novo Chronic Total Occlusions

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Total Occlusion of Coronary Artery Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Graz University Heart Center, Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTO PCI using DCB-only strategy

Device

Successful CTO recanalization treated with DCB at the occlusion site

Primary outcomes

Target lesion failure

Time frame: 6 months

Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization

Secondary outcomes

Late lumen loss

Time frame: 3 months

In-segment late lumen loss on follow-up angiography (in-segment equals DCB plus the proximal and distal 5-mm margins)
Minimal lumen area

Time frame: 3 months

In-segment minimal lumen area on follow-up intravascular ultrasound (IVUS) (in-segment equals DCB plus the proximal and distal 5-mm margins)

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Registry information

Official study title

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

Acronym: CTO-DENOVO

Important dates

Study start: 2012
Primary completion: 2024
Study completion: 2025
First posted: Aug 7, 2023
Registry last updated: Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed