xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05977842</url>
    </required_header>
    <id_info>
      <org_study_id>CTO-DENOVO</org_study_id>
      <nct_id>NCT05977842</nct_id>
    </id_info>
    <brief_title>Drug-coated Balloon in de Novo Chronic Total Occlusions</brief_title>
    <acronym>CTO-DENOVO</acronym>
    <official_title>Drug-coated Balloon in de Novo Chronic Total Occlusions (CTO-DENOVO Registry)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute of Cardiology, Warsaw, Poland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Institute of Cardiology, Warsaw, Poland</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The CTO-DENOVO study is a multicenter registry of consecutive patients with de novo CTO&#xD;
        undergoing successful CTO recanalization with the use of DCB-only strategy. The primary&#xD;
        endpoint is target lesion failure at 6 months. The secondary endpoints are: 1) late lumen&#xD;
        loss on follow-up angiography, and 2) minimal lumen area on follow-up intravascular&#xD;
        ultrasound.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 31, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Target lesion failure</measure>
      <time_frame>6 months</time_frame>
      <description>Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Late lumen loss</measure>
      <time_frame>3 months</time_frame>
      <description>In-segment late lumen loss on follow-up angiography (in-segment equals DCB plus the proximal and distal 5-mm margins)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimal lumen area</measure>
      <time_frame>3 months</time_frame>
      <description>In-segment minimal lumen area on follow-up IVUS (in-segment equals DCB plus the proximal and distal 5-mm margins)</description>
    </secondary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Total Occlusion of Coronary Artery</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CTO PCI using DCB-only strategy</intervention_name>
      <description>Successful CTO recanalization treated with DCB at the occlusion site</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Consecutive patients with de novo CTO undergoing successful PCI with the use of DCB-only&#xD;
          strategy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  de novo coronary CTO undergoing successful recanalization with the use of DCB-only&#xD;
               strategy at the occlusion site&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  de novo coronary CTO undergoing successful recanalization with the use of DES at the&#xD;
               occlusion site&#xD;
  &#xD;
            -  in-stent CTO&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maksymilian Opolski, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Institute of Cardiology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maksymilian Opolski, MD</last_name>
      <phone>+48501444303</phone>
      <email>mopolski@ikard.pl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Županijska bolnica Čakovec</name>
        <address>
          <city>Čakovec</city>
          <country>Croatia</country>
        </address>
      </facility>
      <contact>
        <last_name>Mihajlo Kovacic</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Kardiologické Centrum AGEL</name>
        <address>
          <city>Pardubice</city>
          <country>Czechia</country>
        </address>
      </facility>
      <contact>
        <last_name>Vojtech Novotny</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lille University Hospital</name>
        <address>
          <city>Lille</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Sina Porouchani</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital zum Heiligen Geist</name>
        <address>
          <city>Kempen</city>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Rostislav Prog</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Santissima Annunziata Hospital</name>
        <address>
          <city>Savigliano</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Umberto Barbero</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>American Heart of Poland</name>
        <address>
          <city>Bielsko-Biała</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Krzysztof Milewski</last_name>
      </contact>
      <contact_backup>
        <last_name>Filip Palarczyk</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Jagiellonian University Medical College</name>
        <address>
          <city>Kraków</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Leszek Bryniarski</last_name>
      </contact>
      <contact_backup>
        <last_name>Stanisław Bartuś</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>John Paul II Hospital</name>
        <address>
          <city>Kraków</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Jacek Legutko</last_name>
      </contact>
      <contact_backup>
        <last_name>Daniel Rzeźnik</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>1st Military Hospital</name>
        <address>
          <city>Lublin</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Grzegorz Sobieszek</last_name>
      </contact>
      <contact_backup>
        <last_name>Bartosz Zięba</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>SP ZOZ Hospital</name>
        <address>
          <city>Puławy</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Marek Jankiewicz</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>MSWiA Hospital</name>
        <address>
          <city>Rzeszów</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Wojciech Stecko</last_name>
      </contact>
      <contact_backup>
        <last_name>Piotr Wańczura</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Bielanski Hospital</name>
        <address>
          <city>Warsaw</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Wacław Kochman</last_name>
      </contact>
      <contact_backup>
        <last_name>Szymon Głodała</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>National Institute of Cardiology</name>
        <address>
          <city>Warsaw</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Maksymilian Opolski</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dr Alfred Sokolowski Specialist Hospital</name>
        <address>
          <city>Wałbrzych</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Michał Kryjak</last_name>
      </contact>
      <contact_backup>
        <last_name>Jacek Bezubka</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Silesian Center for Heart Disease</name>
        <address>
          <city>Zabrze</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Mateusz Tajstra</last_name>
      </contact>
      <contact_backup>
        <last_name>Łukasz Pyka</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>MSWiA Hospital</name>
        <address>
          <city>Łódź</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Marcin Makowski</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Heart Institute</name>
        <address>
          <city>Cluj-Napoca</city>
          <country>Romania</country>
        </address>
      </facility>
      <contact>
        <last_name>Mihai Cocoi</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Emergency Clinical County Hospital</name>
        <address>
          <city>Oradea</city>
          <country>Romania</country>
        </address>
      </facility>
      <contact>
        <last_name>Nichita Mihnea</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Croatia</country>
      <country>Czechia</country>
      <country>France</country>
      <country>Germany</country>
      <country>Italy</country>
      <country>Poland</country>
      <country>Romania</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>chronic total occlusion</keyword>
    <keyword>percutaneous coronary intervention</keyword>
    <keyword>drug-coated balloon</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05977842
  org study id: CTO-DENOVO
  nct id: NCT05977842
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Cohort
  time perspective: Retrospective
  measure: Target lesion failure
  time frame: 6 months
  description: Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization
  measure: Late lumen loss
  time frame: 3 months
  description: In-segment late lumen loss on follow-up angiography (in-segment equals DCB plus the proximal and distal 5-mm margins)
  measure: Minimal lumen area
  time frame: 3 months
  description: In-segment minimal lumen area on follow-up IVUS (in-segment equals DCB plus the proximal and distal 5-mm margins)
  intervention type: Device
  intervention name: CTO PCI using DCB-only strategy
  description: Successful CTO recanalization treated with DCB at the occlusion site
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Maksymilian Opolski, MD
  role: Principal Investigator
  affiliation: National Institute of Cardiology
  last name: Maksymilian Opolski, MD
  phone: +48501444303
  email: mopolski@ikard.pl
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  country: Croatia
  country: Czechia
  country: France
  country: Germany
  country: Italy
  country: Poland
  country: Romania
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease