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

December 29, 2025 updated by: National Institute of Cardiology, Warsaw, Poland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

309

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Graz University Heart Center
      • Vienna, Austria
        • Klinik Ottakring
  • Belgium
      • Uccle, Belgium
        • Jolimont Hospital
  • Croatia
      • Čakovec, Croatia
        • Zupanijska bolnica Cakovec
  • Czechia
      • Brno, Czechia
        • University Hospital Brno
      • Liberec, Czechia
        • Liberec Regional Hospital
      • Pardubice, Czechia
        • Kardiologické Centrum AGEL
  • France
      • Lille, France
        • Lille University Hospital
  • Germany
      • Kempen, Germany
        • Hospital zum Heiligen Geist
  • Hungary
      • Debrecen, Hungary
        • University of Debrecen
      • Szeged, Hungary
        • University of Szeged
  • Israel
      • Be’er Ya‘aqov, Israel
        • Shamir Assaf Harofeh MC
  • Italy
      • Milan, Italy
        • Humanitas University
      • Palermo, Italy
        • Villa Sofia Hospital
      • Savigliano, Italy
        • Santissima Annunziata Hospital
  • Poland
      • Bialystok, Poland
        • Medical University of Bialystok
      • Bielsko-Biala, Poland
        • American Heart of Poland
      • Grodzisk Mazowiecki, Poland
        • John Paul II Western Hospital
      • Krakow, Poland
        • John Paul II Hospital
      • Krakow, Poland
        • Jagiellonian University Medical College
      • Lodz, Poland
        • MSWiA Hospital
      • Lublin, Poland
        • 1st Military Hospital
      • Lublin, Poland
        • MSWiA Hospital
      • Poznan, Poland
        • Poznan University of Medical Sciences
      • Puławy, Poland
        • SP ZOZ Hospital
      • Rzeszów, Poland
        • MSWiA Hospital
      • Warsaw, Poland
        • National Institute of Cardiology
      • Warsaw, Poland
        • Bielanski Hospital
      • Warsaw, Poland
        • Military Institute of Medicine
      • Wałbrzych, Poland
        • Dr Alfred Sokolowski Specialist Hospital
      • Wroclaw, Poland
        • Wroclaw Medical University
      • Zabrze, Poland
        • Silesian Center for Heart Disease
  • Romania
      • Cluj-Napoca, Romania
        • Heart Institute
      • Oradea, Romania
        • Emergency Clinical County Hospital
  • Spain
      • Valladolid, Spain
        • Hospital Clinico Universitario de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive patients with de novo CTO undergoing successful PCI with the use of DCB-only strategy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion failure
Time Frame: 6 months
Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late lumen loss
Time Frame: 3 months
In-segment late lumen loss on follow-up angiography (in-segment equals DCB plus the proximal and distal 5-mm margins)
3 months
Minimal lumen area
Time Frame: 3 months
In-segment minimal lumen area on follow-up intravascular ultrasound (IVUS) (in-segment equals DCB plus the proximal and distal 5-mm margins)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiology, Warsaw, Poland

Investigators

  • Principal Investigator: Maksymilian Opolski, MD, National Institute of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2012

Primary Completion (Actual)

December 15, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO-DENOVO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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