Coronary Artery DiseaseCTO-DENOVONCT05977842
Drug-coated Balloon in de Novo Chronic Total Occlusions
An observational study of Coronary Artery Disease and Total Occlusion of Coronary Artery, run by National Institute of Cardiology, Warsaw, Poland at 35 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Total Occlusion of Coronary Artery
- What is being tested?
- CTO PCI using DCB-only strategy
- Type of treatment
- Medical device
- How many people
- 309 participants
- Where
- 35 sitesin 12 countries
- Study dates
- 15 Dec 2012to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with de novo CTO undergoing successful PCI with the use of DCB-only strategy.
Who may be able to join
- de novo coronary CTO undergoing successful recanalization with the use of DCB-only strategy at the occlusion site
Who cannot join
- de novo coronary CTO undergoing successful recanalization with the use of DES at the occlusion site
- in-stent CTO
Trial locations and contacts
35 sites in 12 countries.
35 sites in 12 countries
Poland17 sites
Medical University of Bialystok
Bialystok
American Heart of Poland
Bielsko-Biala
John Paul II Western Hospital
Grodzisk Mazowiecki
Jagiellonian University Medical College
Krakow
John Paul II Hospital
Krakow
MSWiA Hospital
Lodz
1st Military Hospital
Lublin
MSWiA Hospital
Lublin
Poznan University of Medical Sciences
Poznan
SP ZOZ Hospital
Puławy
MSWiA Hospital
Rzeszów
Dr Alfred Sokolowski Specialist Hospital
Wałbrzych
Bielanski Hospital
Warsaw
Military Institute of Medicine
Warsaw
National Institute of Cardiology
Warsaw
Wroclaw Medical University
Wroclaw
Silesian Center for Heart Disease
Zabrze
Czechia3 sites
University Hospital Brno
Brno
Liberec Regional Hospital
Liberec
Kardiologické Centrum AGEL
Pardubice
Italy3 sites
Humanitas University
Milan
Villa Sofia Hospital
Palermo
Santissima Annunziata Hospital
Savigliano
Romania2 sites
Heart Institute
Cluj-Napoca
Emergency Clinical County Hospital
Oradea
About this study
Official title: Drug-coated Balloon in de Novo Chronic Total Occlusions (CTO-DENOVO Registry)
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.
- Being tested
- CTO PCI using DCB-only strategy
- Keywords
- chronic total occlusion, percutaneous coronary intervention, drug-coated balloon
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO PCI using DCB-only strategyDevice
Successful CTO recanalization treated with DCB at the occlusion site
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization
Measured: 6 months
Secondary outcomes (2)
Late lumen loss
In-segment late lumen loss on follow-up angiography (in-segment equals DCB plus the proximal and distal 5-mm margins)
Measured: 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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start15 Dec 2012
- Primary completion15 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maksymilian Opolski, MD, Principal investigator, National Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977842
- Sponsor's protocol ID
- CTO-DENOVO
- Acronym
- CTO-DENOVO
- Status last verified
- Oct 2025
- First submitted
- 28 Jul 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-coated Balloon in de Novo Chronic Total Occlusions (CTO-DENOVO Registry)
- ClinicalTrials.gov ID
- NCT05977842
- Acronym / sponsor ID
- CTO-DENOVO / CTO-DENOVO
- Keywords
- chronic total occlusion, percutaneous coronary intervention, drug-coated balloon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- 15 Dec 2012 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with de novo CTO undergoing successful PCI with the use of DCB-only strategy.
Key inclusion criteria (1 listed)
- de novo coronary CTO undergoing successful recanalization with the use of DCB-only strategy at the occlusion site
Key exclusion criteria (2 listed)
- de novo coronary CTO undergoing successful recanalization with the use of DES at the occlusion site
- in-stent CTO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTO PCI using DCB-only strategySuccessful CTO recanalization treated with DCB at the occlusion site | Device | – |
Primary outcome
Target lesion failure
Time frame: 6 months
Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization
2 secondary outcomes
Late lumen loss
Time frame: 3 months
Minimal lumen area
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maksymilian Opolski, MD principal investigator
National Institute of Cardiology
35 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Total Occlusion of Coronary Artery, run by National Institute of Cardiology, Warsaw, Poland at 35 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Poland, Czechia, Italy, Austria, Hungary and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.