Drug-coated Balloon in de Novo Chronic Total Occlusions

Recruiting

• Conditions: Coronary Artery Disease; Total Occlusion of Coronary Artery

• Registration Number: NCT05977842
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-07
• Study Start: 2024-01-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion failure	6 months	Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (33)

Dr Alfred Sokolowski Specialist Hospital; 🇵🇱 Wałbrzych, Poland

Jolimont Hospital; 🇧🇪 Uccle, Belgium

Graz University Heart Center; 🇦🇹 Graz, Austria

Klinik Ottakring; 🇦🇹 Vienna, Austria

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

Jagiellonian University Medical College; 🇵🇱 Kraków, Poland

John Paul II Hospital; 🇵🇱 Kraków, Poland

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; 🇵🇱 Białystok, Poland

American Heart of Poland; 🇵🇱 Bielsko-Biała, Poland

John Paul II Western Hospital; 🇵🇱 Grodzisk Mazowiecki, Poland

1st Military Hospital; 🇵🇱 Lublin, Poland

MSWiA Hospital; 🇵🇱 Łódź, Poland

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poland

SP ZOZ Hospital; 🇵🇱 Puławy, Poland

Bielanski Hospital; 🇵🇱 Warsaw, Poland

Military Institute of Medicine; 🇵🇱 Warsaw, Poland

National Institute of Cardiology; 🇵🇱 Warsaw, Poland

Wroclaw Medical University; 🇵🇱 Wrocław, 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