Coronary Artery Disease, Total Occlusion of Coronary Artery
Conditions
Keywords
chronic total occlusion, percutaneous coronary intervention, drug-coated balloon
Brief 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.
Interventions
DEVICECTO PCI using DCB-only strategy
Successful CTO recanalization treated with DCB at the occlusion site
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 6 months | Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late lumen loss | 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 | 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) |
Countries
Austria, Belgium, Croatia, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Romania, Spain
Outcome results
None listed