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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05977842
Recruitment Status : Recruiting
First Posted : August 7, 2023
Last Update Posted : February 9, 2024
Sponsor:
Information provided by (Responsible Party):
National Institute of Cardiology, Warsaw, Poland

Study Description
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Brief Summary:
The CTO-DENOVO study is a multicenter registry of consecutive patients with de novo CTO undergoing successful CTO recanalization with the use of 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.

Condition or disease Intervention/treatment
Coronary Artery Disease Total Occlusion of Coronary Artery Device: CTO PCI using DCB-only strategy

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Drug-coated Balloon in de Novo Chronic Total Occlusions (CTO-DENOVO Registry)
Estimated Study Start Date : January 31, 2024
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: CTO PCI using DCB-only strategy
    Successful CTO recanalization treated with DCB at the occlusion site

Outcome Measures
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Primary Outcome Measures :
  1. Target lesion failure [ Time Frame: 6 months ]
    Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization


Secondary Outcome Measures :
  1. 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)

  2. Minimal lumen area [ Time Frame: 3 months ]
    In-segment minimal lumen area on follow-up IVUS (in-segment equals DCB plus the proximal and distal 5-mm margins)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05977842


Contacts
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Contact: Maksymilian Opolski, MD +48501444303 mopolski@ikard.pl

Locations
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Sponsors and Collaborators
National Institute of Cardiology, Warsaw, Poland
Investigators
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Principal Investigator: Maksymilian Opolski, MD National Institute of Cardiology
More Information
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Responsible Party: National Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT05977842    
Other Study ID Numbers: CTO-DENOVO
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: February 9, 2024
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Cardiology, Warsaw, Poland:
chronic total occlusion
percutaneous coronary intervention
drug-coated balloon
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases