<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/NCT04409717</url>
  </required_header>
  <id_info>
    <org_study_id>CCVT - type 2 endoleaks</org_study_id>
    <nct_id>NCT04409717</nct_id>
  </id_info>
  <brief_title>Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks</brief_title>
  <official_title>Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but&#xD;
      exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has&#xD;
      proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The&#xD;
      investigators described the different techniques of type 2 endovascular repair, and their&#xD;
      efficacy at short and long term..&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">May 26, 2020</completion_date>
  <primary_completion_date type="Actual">May 26, 2020</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>Recurrence rate of type II endoleaks treated with endovascular intervention</measure>
    <time_frame>12 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of type II endoleaks treatment</measure>
    <time_frame>12 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">19</enrollment>
  <condition>Abdominal Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>Patients treated for type II endoleaks</arm_group_label>
    <description>Patients treated for type II endoleaks between the 01 January 2008 and the 31 March 2018 in the Cardiovascular and Thoracic Surgery Unit of Dijon Burgundy University Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Type II endoleak treatment</intervention_name>
    <description>Type II endoleak endovascular treatment</description>
    <arm_group_label>Patients treated for type II endoleaks</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated for type II endoleaks by endovascular therapy between the 01 January&#xD;
        2008 and the 31 December 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients treated for type II endoleaks by endovascular therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric STEINMETZ, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiovascular and Thoracic Surgery Unit - Dijon Univeristy Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiovascular and thoracic surgery unit, CHU Dijon</name>
      <address>
        <city>Dijon Cedex</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Dijon</investigator_affiliation>
    <investigator_full_name>Eric STEINMETZ</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
    <mesh_term>Endoleak</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes.&#xD;
Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.</ipd_description>
  </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/NCT04409717
org study id: CCVT - type 2 endoleaks
nct id: NCT04409717
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but
      exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has
      proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The
      investigators described the different techniques of type 2 endovascular repair, and their
      efficacy at short and long term..
observational model: Cohort
time perspective: Retrospective
measure: Recurrence rate of type II endoleaks treated with endovascular intervention
time frame: 12 years
measure: Type of type II endoleaks treatment
time frame: 12 years
arm group label: Patients treated for type II endoleaks
description: Patients treated for type II endoleaks between the 01 January 2008 and the 31 March 2018 in the Cardiovascular and Thoracic Surgery Unit of Dijon Burgundy University Hospital
intervention type: Procedure
intervention name: Type II endoleak treatment
description: Type II endoleak endovascular treatment
arm group label: Patients treated for type II endoleaks
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Eric STEINMETZ, MD
role: Principal Investigator
affiliation: Cardiovascular and Thoracic Surgery Unit - Dijon Univeristy Hospital
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Dijon
investigator full name: Eric STEINMETZ
investigator title: Professor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
mesh term: Endoleak
sharing ipd: No
ipd description: All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes.
Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.