Drug-coated Balloon in de Novo Chronic Total Occlusions

Coronary Artery Disease Clinical Trial

— CTO-DENOVO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977842
• Other study ID #: CTO-DENOVO
• Status: Recruiting
• Start date: January 31, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: National Institute of Cardiology, Warsaw, Poland
• Contact: Maksymilian Opolski, MD
• Phone: +48501444303
• Email: mopolski[@]ikard.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The CTO-DENOVO study is a multicenter registry of consecutive patients with de novo CTO undergoing successful CTO recanalization with the use of 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Total Occlusion of Coronary Artery

Intervention

Device:
• CTO PCI using DCB-only strategy
Successful CTO recanalization treated with DCB at the occlusion site

Locations

Country	Name	City	State
Austria	Graz University Heart Center	Graz
Austria	Klinik Ottakring	Vienna
Croatia	Županijska bolnica Cakovec	Cakovec
Czechia	University Hospital Brno	Brno
Czechia	Liberec Regional Hospital	Liberec
Czechia	Kardiologické Centrum AGEL	Pardubice
France	Lille University Hospital	Lille
Germany	Hospital zum Heiligen Geist	Kempen
Hungary	University of Debrecen	Debrecen
Hungary	University of Szeged	Szeged
Israel	Shamir Assaf Harofeh MC	Be'er Ya'aqov
Italy	Humanitas University	Milan
Italy	Villa Sofia Hospital	Palermo
Italy	Santissima Annunziata Hospital	Savigliano
Poland	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	Kraków
Poland	John Paul II Hospital	Kraków
Poland	MSWiA Hospital	Lódz
Poland	1st Military Hospital	Lublin
Poland	MSWiA Hospital	Lublin
Poland	Poznan University of Medical Sciences	Poznan
Poland	SP ZOZ Hospital	Pulawy
Poland	MSWiA Hospital	Rzeszów
Poland	Dr Alfred Sokolowski Specialist Hospital	Walbrzych
Poland	Bielanski Hospital	Warsaw
Poland	Military Institute of Medicine	Warsaw
Poland	National Institute of Cardiology	Warsaw
Poland	Wroclaw Medical University	Wroclaw
Poland	Silesian Center for Heart Disease	Zabrze
Romania	Heart Institute	Cluj-Napoca
Romania	Emergency Clinical County Hospital	Oradea
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Warsaw, Poland

Countries where clinical trial is conducted

Austria,  Croatia,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization	6 months
Secondary	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
Secondary	Minimal lumen area	In-segment minimal lumen area on follow-up IVUS (in-segment equals DCB plus the proximal and distal 5-mm margins)	3 months