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.
Study Type
OBSERVATIONAL
Enrollment
309
Successful CTO recanalization treated with DCB at the occlusion site
Target lesion failure
Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization
Time frame: 6 months
Late lumen loss
In-segment late lumen loss on follow-up angiography (in-segment equals DCB plus the proximal and distal 5-mm margins)
Time frame: 3 months
Minimal lumen area
In-segment minimal lumen area on follow-up intravascular ultrasound (IVUS) (in-segment equals DCB plus the proximal and distal 5-mm margins)
Time frame: 3 months
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