Drug-coated Balloon in de Novo Chronic Total Occlusions

NCT ID: NCT05977842

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-15

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Total Occlusion of Coronary Artery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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CTO PCI using DCB-only strategy

Successful CTO recanalization treated with DCB at the occlusion site

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maksymilian Opolski, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology

Locations

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Graz University Heart Center

Graz, , Austria

Site Status

Klinik Ottakring

Vienna, , Austria

Site Status

Jolimont Hospital

Uccle, , Belgium

Site Status

Županijska bolnica Čakovec

Čakovec, , Croatia

Site Status

University Hospital Brno

Brno, , Czechia

Site Status

Liberec Regional Hospital

Liberec, , Czechia

Site Status

Kardiologické Centrum AGEL

Pardubice, , Czechia

Site Status

Lille University Hospital

Lille, , France

Site Status

Hospital zum Heiligen Geist

Kempen, , Germany

Site Status

University of Debrecen

Debrecen, , Hungary

Site Status

University of Szeged

Szeged, , Hungary

Site Status

Shamir Assaf Harofeh MC

Be’er Ya‘aqov, , Israel

Site Status

Humanitas University

Milan, , Italy

Site Status

Villa Sofia Hospital

Palermo, , Italy

Site Status

Santissima Annunziata Hospital

Savigliano, , Italy

Site Status

Medical University of Bialystok

Bialystok, , Poland

Site Status

American Heart of Poland

Bielsko-Biala, , Poland

Site Status

John Paul II Western Hospital

Grodzisk Mazowiecki, , Poland

Site Status

Jagiellonian University Medical College

Krakow, , Poland

Site Status

John Paul II Hospital

Krakow, , Poland

Site Status

MSWiA Hospital

Lodz, , Poland

Site Status

1st Military Hospital

Lublin, , Poland

Site Status

MSWiA Hospital

Lublin, , Poland

Site Status

Poznan University of Medical Sciences

Poznan, , Poland

Site Status

SP ZOZ Hospital

Puławy, , Poland

Site Status

MSWiA Hospital

Rzeszów, , Poland

Site Status

Bielanski Hospital

Warsaw, , Poland

Site Status

Military Institute of Medicine

Warsaw, , Poland

Site Status

National Institute of Cardiology

Warsaw, , Poland

Site Status

Dr Alfred Sokolowski Specialist Hospital

Wałbrzych, , Poland

Site Status

Wroclaw Medical University

Wroclaw, , Poland

Site Status

Silesian Center for Heart Disease

Zabrze, , Poland

Site Status

Heart Institute

Cluj-Napoca, , Romania

Site Status

Emergency Clinical County Hospital

Oradea, , Romania

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Countries

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Austria Belgium Croatia Czechia France Germany Hungary Israel Italy Poland Romania Spain

Other Identifiers

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CTO-DENOVO

Identifier Type: -

Identifier Source: org_study_id

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