Drug-coated Balloon in de Novo Chronic Total Occlusions
CTO-DENOVO
1 other identifier
observational
309
12 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Longer than P75 for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2012
CompletedFirst Submitted
Initial submission to the registry
July 28, 2023
CompletedFirst Posted
Study publicly available on registry
August 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJanuary 2, 2026
October 1, 2025
12 years
July 28, 2023
December 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target lesion failure
Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization
6 months
Secondary Outcomes (2)
Late lumen loss
3 months
Minimal lumen area
3 months
Interventions
Successful CTO recanalization treated with DCB at the occlusion site
Eligibility Criteria
Consecutive patients with de novo CTO undergoing successful PCI with the use of DCB-only strategy.
You may qualify if:
- de novo coronary CTO undergoing successful recanalization with the use of DCB-only strategy at the occlusion site
You may not qualify if:
- de novo coronary CTO undergoing successful recanalization with the use of DES at the occlusion site
- in-stent CTO
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Graz University Heart Center
Graz, Austria
Klinik Ottakring
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maksymilian Opolski, MD
National Institute of Cardiology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2023
First Posted
August 7, 2023
Study Start
December 15, 2012
Primary Completion
December 15, 2024
Study Completion
January 1, 2025
Last Updated
January 2, 2026
Record last verified: 2025-10