Clinical trial NCT05977842: Drug-coated Balloon in de Novo Chronic Total Occlusions
Official title: Drug-coated Balloon in de Novo Chronic Total Occlusions (CTO-DENOVO Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Total Occlusion of Coronary Artery
Keywords: chronic total occlusion
percutaneous coronary intervention
drug-coated balloon
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with de novo CTO undergoing successful PCI with the use of DCB-only strategy.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Target lesion failure
timeFrame: 6 months
Secondary outcomes:
measure: Late lumen loss
timeFrame: 3 months
measure: Minimal lumen area
timeFrame: 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Graz University Heart Center
city: Vienna
country: Austria
facility: Klinik Ottakring
city: Uccle
country: Belgium
facility: Jolimont Hospital
city: Čakovec
country: Croatia
facility: Županijska bolnica Čakovec
city: Brno
country: Czechia
facility: University Hospital Brno
city: Liberec
country: Czechia
facility: Liberec Regional Hospital
city: Pardubice
country: Czechia
facility: Kardiologické Centrum AGEL
city: Lille
country: France
facility: Lille University Hospital
city: Kempen
country: Germany
facility: Hospital zum Heiligen Geist
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Szeged
country: Hungary
facility: University of Szeged
city: Be'er Ya'aqov
country: Israel
facility: Shamir Assaf Harofeh MC
city: Milan
country: Italy
facility: Humanitas University
city: Palermo
country: Italy
facility: Villa Sofia Hospital
city: Savigliano
country: Italy
facility: Santissima Annunziata Hospital
city: Białystok
country: Poland
facility: Medical University of Bialystok
city: Bielsko-Biała
country: Poland
facility: American Heart of Poland
city: Grodzisk Mazowiecki
country: Poland
facility: John Paul II Western Hospital
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
city: Kraków
country: Poland
facility: John Paul II Hospital
city: Lublin
country: Poland
facility: 1st Military Hospital
city: Lublin
country: Poland
facility: MSWiA Hospital
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
city: Puławy
country: Poland
facility: SP ZOZ Hospital
city: Rzeszów
country: Poland
facility: MSWiA Hospital
city: Warsaw
country: Poland
facility: Bielanski Hospital
city: Warsaw
country: Poland
facility: Military Institute of Medicine
city: Warsaw
country: Poland
facility: National Institute of Cardiology
city: Wałbrzych
country: Poland
facility: Dr Alfred Sokolowski Specialist Hospital
city: Wrocław
country: Poland
facility: Wroclaw Medical University
city: Zabrze
country: Poland
facility: Silesian Center for Heart Disease
city: Łódź
country: Poland
facility: MSWiA Hospital
city: Cluj-Napoca
country: Romania
facility: Heart Institute
city: Oradea
country: Romania
facility: Emergency Clinical County Hospital
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: National Institute of Cardiology
name: Maksymilian Opolski, MD
role: PRINCIPAL_INVESTIGATOR
References: