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NCT05977842Completed

Drug-coated Balloon in de Novo Chronic Total Occlusions

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

Source: ClinicalTrials.gov · Last updated 2 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
309 (actual)
First submitted
28 Jul 2023
Start date
15 Dec 2012
Primary completion date
15 Dec 2024
Lead sponsor
National Institute of Cardiology, Warsaw, Poland
NCT number
NCT05977842

What you commit to

  • Study type: Observational
  • Participants enrolled: 309
  • From 15 Dec 2012 to the primary completion date, 15 Dec 2024
  • 35 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • de novo coronary CTO undergoing successful recanalization with the use of DES at the occlusion site
  • in-stent CTO

Who the study is looking for

  • de novo coronary CTO undergoing successful recanalization with the use of DCB-only strategy at the occlusion site

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Graz University Heart Center
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GrazAustriaUnknown status
Klinik Ottakring
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ViennaAustriaUnknown status
Jolimont Hospital
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UccleBelgiumUnknown status
University Hospital Brno
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BrnoCzechiaUnknown status
Liberec Regional Hospital
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LiberecCzechiaUnknown status
Kardiologické Centrum AGEL
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PardubiceCzechiaUnknown status
Hospital zum Heiligen Geist
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KempenGermanyUnknown status
Hospital Clínico Universitario de Valladolid
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ValladolidSpainUnknown status
Lille University Hospital
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LilleFranceUnknown status
Zupanijska bolnica Cakovec
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ČakovecCroatiaUnknown status
University of Debrecen
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DebrecenHungaryUnknown status
University of Szeged
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SzegedHungaryUnknown status
Shamir Assaf Harofeh MC
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Be’er Ya‘aqovIsraelUnknown status
Humanitas University
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MilanItalyUnknown status
Villa Sofia Hospital
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PalermoItalyUnknown status
Santissima Annunziata Hospital
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SaviglianoItalyUnknown status
Medical University of Bialystok
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BialystokPolandUnknown status
American Heart of Poland
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Bielsko-BialaPolandUnknown status
John Paul II Western Hospital
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Grodzisk MazowieckiPolandUnknown status
John Paul II Hospital
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KrakowPolandUnknown status
Jagiellonian University Medical College
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KrakowPolandUnknown status
MSWiA Hospital
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LodzPolandUnknown status
1st Military Hospital
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LublinPolandUnknown status
MSWiA Hospital
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LublinPolandUnknown status
Poznan University of Medical Sciences
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PoznanPolandUnknown status
SP ZOZ Hospital
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PuławyPolandUnknown status
MSWiA Hospital
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RzeszówPolandUnknown status
Dr Alfred Sokolowski Specialist Hospital
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WałbrzychPolandUnknown status
Military Institute of Medicine
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WarsawPolandUnknown status
Bielanski Hospital
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WarsawPolandUnknown status
National Institute of Cardiology
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WarsawPolandUnknown status
Wroclaw Medical University
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WroclawPolandUnknown status
Silesian Center for Heart Disease
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ZabrzePolandUnknown status
Heart Institute
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Cluj-NapocaRomaniaUnknown status
Emergency Clinical County Hospital
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OradeaRomaniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.