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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTO PCI using DCB-only strategy | Device | Successful CTO recanalization treated with DCB at the occlusion site |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss | In-segment late lumen loss on follow-up angiography (in-segment equals DCB plus the proximal and distal 5-mm margins) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients with de novo CTO undergoing successful PCI with the use of DCB-only strategy.
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| Name | Affiliation | Role |
|---|---|---|
| Maksymilian Opolski, MD | National Institute of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graz University Heart Center | Graz | Austria | ||||
| Klinik Ottakring |
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| 3 months |
| Vienna |
| Austria |
| Jolimont Hospital | Uccle | Belgium |
| Županijska bolnica Čakovec | Čakovec | Croatia |
| University Hospital Brno | Brno | Czechia |
| Liberec Regional Hospital | Liberec | Czechia |
| Kardiologické Centrum AGEL | Pardubice | Czechia |
| Lille University Hospital | Lille | France |
| Hospital zum Heiligen Geist | Kempen | Germany |
| University of Debrecen | Debrecen | Hungary |
| University of Szeged | Szeged | Hungary |
| Shamir Assaf Harofeh MC | Be’er Ya‘aqov | Israel |
| Humanitas University | Milan | Italy |
| Villa Sofia Hospital | Palermo | Italy |
| Santissima Annunziata Hospital | Savigliano | Italy |
| Medical University of Bialystok | Bialystok | Poland |
| American Heart of Poland | Bielsko-Biala | Poland |
| John Paul II Western Hospital | Grodzisk Mazowiecki | Poland |
| Jagiellonian University Medical College | Krakow | Poland |
| John Paul II Hospital | Krakow | Poland |
| MSWiA Hospital | Lodz | Poland |
| 1st Military Hospital | Lublin | Poland |
| MSWiA Hospital | Lublin | Poland |
| Poznan University of Medical Sciences | Poznan | Poland |
| SP ZOZ Hospital | Puławy | Poland |
| MSWiA Hospital | Rzeszów | Poland |
| Bielanski Hospital | Warsaw | Poland |
| Military Institute of Medicine | Warsaw | Poland |
| National Institute of Cardiology | Warsaw | Poland |
| Dr Alfred Sokolowski Specialist Hospital | Wałbrzych | Poland |
| Wroclaw Medical University | Wroclaw | Poland |
| Silesian Center for Heart Disease | Zabrze | Poland |
| Heart Institute | Cluj-Napoca | Romania |
| Emergency Clinical County Hospital | Oradea | Romania |
| Hospital Clínico Universitario de Valladolid | Valladolid | Spain |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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