Drug-coated Balloon in de Novo Chronic Total Occlusions

Last updated: November 24, 2025
Sponsor: National Institute of Cardiology, Warsaw, Poland
Overall Status: Completed

Phase

N/A

Condition

Heart Disease

Atherosclerosis

Chest Pain

Treatment

CTO PCI using DCB-only strategy

Clinical Study ID

NCT05977842
CTO-DENOVO
  • Ages > 18
  • All Genders

Study 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. The secondary endpoints are: 1) late lumen loss on follow-up angiography, and 2) minimal lumen area on follow-up intravascular ultrasound.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • de novo coronary CTO undergoing successful recanalization with the use of DES at theocclusion site

  • in-stent CTO

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: CTO PCI using DCB-only strategy
Phase:
Study Start date:
December 15, 2012
Estimated Completion Date:
January 01, 2025

Connect with a study center

  • Graz University Heart Center

    Graz,
    Austria

    Site Not Available

  • Graz University Heart Center

    Graz 2778067,
    Austria

    Site Not Available

  • Klinik Ottakring

    Vienna,
    Austria

    Site Not Available

  • Klinik Ottakring

    Vienna 2761369,
    Austria

    Site Not Available

  • Jolimont Hospital

    Uccle,
    Belgium

    Site Not Available

  • Jolimont Hospital

    Uccle 2785123,
    Belgium

    Site Not Available

  • Županijska bolnica Čakovec

    Čakovec,
    Croatia

    Site Not Available

  • Županijska bolnica Čakovec

    Čakovec 3202888,
    Croatia

    Site Not Available

  • University Hospital Brno

    Brno,
    Czechia

    Site Not Available

  • University Hospital Brno

    Brno 3078610,
    Czechia

    Site Not Available

  • Liberec Regional Hospital

    Liberec,
    Czechia

    Site Not Available

  • Liberec Regional Hospital

    Liberec 3071961,
    Czechia

    Site Not Available

  • Kardiologické Centrum AGEL

    Pardubice,
    Czechia

    Site Not Available

  • Kardiologické Centrum AGEL

    Pardubice 3068582,
    Czechia

    Site Not Available

  • Lille University Hospital

    Lille,
    France

    Site Not Available

  • Lille University Hospital

    Lille 2998324,
    France

    Site Not Available

  • Hospital zum Heiligen Geist

    Kempen,
    Germany

    Site Not Available

  • Hospital zum Heiligen Geist

    Kempen 2891643,
    Germany

    Site Not Available

  • University of Debrecen

    Debrecen,
    Hungary

    Site Not Available

  • University of Debrecen

    Debrecen 721472,
    Hungary

    Site Not Available

  • University of Szeged

    Szeged,
    Hungary

    Site Not Available

  • University of Szeged

    Szeged 715429,
    Hungary

    Site Not Available

  • Shamir Assaf Harofeh MC

    Be'er Ya'aqov,
    Israel

    Site Not Available

  • Shamir Assaf Harofeh MC

    Be’er Ya‘aqov 295525,
    Israel

    Site Not Available

  • Humanitas University

    Milan,
    Italy

    Site Not Available

  • Humanitas University

    Milan 3173435,
    Italy

    Site Not Available

  • University of Palermo

    Palermo,
    Italy

    Site Not Available

  • Villa Sofia Hospital

    Palermo,
    Italy

    Site Not Available

  • Villa Sofia Hospital

    Palermo 2523920,
    Italy

    Site Not Available

  • Santissima Annunziata Hospital

    Savigliano,
    Italy

    Site Not Available

  • Santissima Annunziata Hospital

    Savigliano 3167034,
    Italy

    Site Not Available

  • Medical University of Bialystok

    Bialystok 776069,
    Poland

    Site Not Available

  • Medical University of Bialystok

    Białystok,
    Poland

    Site Not Available

  • American Heart of Poland

    Bielsko-Biala 3103402,
    Poland

    Site Not Available

  • American Heart of Poland

    Bielsko-Biała,
    Poland

    Site Not Available

  • John Paul II Western Hospital

    Grodzisk Mazowiecki,
    Poland

    Site Not Available

  • John Paul II Western Hospital

    Grodzisk Mazowiecki 771401,
    Poland

    Site Not Available

  • Jagiellonian University Medical College

    Krakow 3094802,
    Poland

    Site Not Available

  • John Paul II Hospital

    Krakow 3094802,
    Poland

    Site Not Available

  • Jagiellonian University Medical College

    Kraków,
    Poland

    Site Not Available

  • John Paul II Hospital

    Kraków,
    Poland

    Active - Recruiting

  • MSWiA Hospital

    Lodz 3093133,
    Poland

    Site Not Available

  • 1st Military Hospital

    Lublin,
    Poland

    Active - Recruiting

  • MSWiA Hospital

    Lublin,
    Poland

    Site Not Available

  • 1st Military Hospital

    Lublin 765876,
    Poland

    Site Not Available

  • MSWiA Hospital

    Lublin 765876,
    Poland

    Site Not Available

  • Poznan University of Medical Sciences

    Poznan,
    Poland

    Site Not Available

  • Poznan University of Medical Sciences

    Poznan 3088171,
    Poland

    Site Not Available

  • SP ZOZ Hospital

    Puławy,
    Poland

    Site Not Available

  • SP ZOZ Hospital

    Puławy 760924,
    Poland

    Site Not Available

  • MSWiA Hospital

    Rzeszów,
    Poland

    Site Not Available

  • MSWiA Hospital

    Rzeszów 759734,
    Poland

    Site Not Available

  • Bielanski Hospital

    Warsaw,
    Poland

    Active - Recruiting

  • Military Institute of Medicine

    Warsaw,
    Poland

    Site Not Available

  • National Institute of Cardiology

    Warsaw,
    Poland

    Active - Recruiting

  • Bielanski Hospital

    Warsaw 756135,
    Poland

    Site Not Available

  • Military Institute of Medicine

    Warsaw 756135,
    Poland

    Site Not Available

  • National Institute of Cardiology

    Warsaw 756135,
    Poland

    Site Not Available

  • Dr Alfred Sokolowski Specialist Hospital

    Wałbrzych,
    Poland

    Site Not Available

  • Dr Alfred Sokolowski Specialist Hospital

    Wałbrzych 3082707,
    Poland

    Site Not Available

  • Wroclaw Medical University

    Wroclaw 3081368,
    Poland

    Site Not Available

  • Wroclaw Medical University

    Wrocław,
    Poland

    Site Not Available

  • Silesian Center for Heart Disease

    Zabrze,
    Poland

    Site Not Available

  • Silesian Center for Heart Disease

    Zabrze 3080985,
    Poland

    Site Not Available

  • MSWiA Hospital

    Łódź,
    Poland

    Site Not Available

  • Heart Institute

    Cluj-Napoca,
    Romania

    Site Not Available

  • Heart Institute

    Cluj-Napoca 681290,
    Romania

    Site Not Available

  • Emergency Clinical County Hospital

    Oradea,
    Romania

    Site Not Available

  • Emergency Clinical County Hospital

    Oradea 671768,
    Romania

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid,
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid 3106672,
    Spain

    Site Not Available

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