<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/NCT04415216</url>
  </required_header>
  <id_info>
    <org_study_id>02</org_study_id>
    <nct_id>NCT04415216</nct_id>
  </id_info>
  <brief_title>DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)</brief_title>
  <acronym>DEB-DRAGON</acronym>
  <official_title>Long-term Outcomes Following Drug Eluting Balloon Versus Thin Struts Drug Eluting Stents for Treating In-stent Restenosis: Propensity Score-matched Analysis(DEB-Dragon Registry).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Silesia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wojciech Wojakowski</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Silesia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting&#xD;
      balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis&#xD;
      (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy&#xD;
      and safety profile of DEB and thin-DES in DES-ISR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>TLR</measure>
    <time_frame>3 years</time_frame>
    <description>target lesion revascularisation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DOCE</measure>
    <time_frame>3 years</time_frame>
    <description>composite of cardiac death, TLR, and target vessel MI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TVR</measure>
    <time_frame>3 years</time_frame>
    <description>target vessel revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TV-MI</measure>
    <time_frame>3 years</time_frame>
    <description>target vessel myocardial infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac death</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1369</enrollment>
  <condition>In Stent Restenosis</condition>
  <arm_group>
    <arm_group_label>ISR PCI with thin-DES</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ISR PCI with DEB</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>percutaneous coronary intervention</intervention_name>
    <description>Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)</description>
    <arm_group_label>ISR PCI with DEB</arm_group_label>
    <arm_group_label>ISR PCI with thin-DES</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or&#xD;
        thin-DES.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PCI with DES struts thickness &gt;100μm&#xD;
&#xD;
          -  PCI with DEB and thin-DES in the same procedure&#xD;
&#xD;
          -  PCI of other vascular territories during the same procedure&#xD;
&#xD;
          -  PCI in saphenous vain graft or internal mammary artery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Department of Invasive Cardiology, Medical University of Bialystok</name>
      <address>
        <city>Białystok</city>
        <zip>15-089</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Institute, Nicolaus Copernicus University, Bydgoszcz, Poland</name>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland</name>
      <address>
        <city>Gdańsk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland</name>
      <address>
        <city>Katowice</city>
        <zip>40-635</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Third Department of Cardiology, Medical University of Katowice</name>
      <address>
        <city>Zabrze</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>September 18, 2021</last_update_submitted>
  <last_update_submitted_qc>September 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Silesia</investigator_affiliation>
    <investigator_full_name>Wojciech Wańha</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04415216
org study id: 02
nct id: NCT04415216
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting
      balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis
      (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy
      and safety profile of DEB and thin-DES in DES-ISR.
observational model: Cohort
time perspective: Cross-Sectional
measure: TLR
time frame: 3 years
description: target lesion revascularisation
measure: DOCE
time frame: 3 years
description: composite of cardiac death, TLR, and target vessel MI
measure: TVR
time frame: 3 years
description: target vessel revascularization
measure: TV-MI
time frame: 3 years
description: target vessel myocardial infarction
measure: cardiac death
time frame: 3 years
measure: myocardial infarction
time frame: 3 years
arm group label: ISR PCI with thin-DES
arm group label: ISR PCI with DEB
intervention type: Device
intervention name: percutaneous coronary intervention
description: Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)
arm group label: ISR PCI with DEB
arm group label: ISR PCI with thin-DES
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Silesia
investigator full name: Wojciech Wańha
investigator title: MD, PhD
sharing ipd: Undecided