<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/NCT04489277</url>
  </required_header>
  <id_info>
    <org_study_id>INSERM UMR_S 999</org_study_id>
    <nct_id>NCT04489277</nct_id>
  </id_info>
  <brief_title>Silent Brain Infarction After Endovascular Arch Procedures</brief_title>
  <official_title>Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results From the STEP Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vascular Surgical Research Group, Imperial College, London, UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sanger Heart and Vascular Institute, Charlotte, NC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Loyola University Medical Center, Maywood, IL</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UAB School of Medicine, Birmingham, AL</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heidelberg University Hospital, Heidelberg, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of Freiburg, Freiburg, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor Research Hospital, Dallas, TX</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University Hospital, Atlanta, GA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of Mainz, Mainz, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Diakonie Hospital Jung-Stilling, Siegen, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mayo Clinic, Rochester, MN</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sentara Vascular/Eastern Virginia Medical School, Norfolk, VA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maastricht University Medical Centre, Maastricht, Netherlands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Memorial Care Long Beach Heart &amp; Vascular Institute, Long Beach, CA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</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>
      This is the largest study to evaluate incidence and distribution of silent cerebral&#xD;
      infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is&#xD;
      the first cohort to include total endovascular arch repair and devices flushed with carbon&#xD;
      dioxide (CO2) to prevent gaseous cerebral embolization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction. Poor data exist concerning the rate of silent cerebral ischemic events&#xD;
      following endovascular treatment of the aortic arch. The objective of this work was to&#xD;
      quantify these lesions using the STEP registry.&#xD;
&#xD;
      Methods. This multicentre retrospective cohort study included consecutive patients treated&#xD;
      with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted&#xD;
      magnetic resonance imaging (DW-MRI) within 7 days after the procedure. DW-MRI was performed&#xD;
      to identify the location and number of new silent brain infarctions (SBI), microbleeds ans&#xD;
      general outcome of the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</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>Other</time_perspective>
  </study_design_info>
  <target_duration>17 Months</target_duration>
  <primary_outcome>
    <measure>frequency of silent cerebral infarcts on DW-MRI</measure>
    <time_frame>7 days</time_frame>
    <description>Primary outcomes were the frequency of silent cerebral infarcts on DW-MRI after endovascular arch procedures, and to identify the number, the distribution, and predictors of these lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>perioperative ischemic stroke</measure>
    <time_frame>30 days</time_frame>
    <description>Secondary outcomes were perioperative ischemic stroke defined as a brain infarction of ischemic etiology which occurs during surgery or within 30 days after surgery, TIA, hemorrhagic stroke, 30-day mortality, spinal cord ischemia, length of stay and discharge disposition.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">91</enrollment>
  <condition>Aortic Arch Aneurysm</condition>
  <arm_group>
    <arm_group_label>Patients with Silent Brain Infarction</arm_group_label>
    <description>treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure with silent brain infarction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without Silent Brain Infarction</arm_group_label>
    <description>treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure without silent brain infarction</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endovascular Arch Procedures</intervention_name>
    <description>Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)</description>
    <arm_group_label>Patients with Silent Brain Infarction</arm_group_label>
    <arm_group_label>Patients without Silent Brain Infarction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients, who received routine postoperative DW-MRI within 7 days after&#xD;
        endovascular aortic arch repair between September 2018 and January 2020 at the University&#xD;
        Hospital Hamburg-Eppendorf (Hamburg, Germany) and Marie Lannelongue Hospital (Paris,&#xD;
        France) were identified.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Included patients underwent a proximal endograft deployment in Ishimaru zone 0 to 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Missing preoperative computed tomography angiography (CTA) scan of the chest and any&#xD;
             circumstances that precluded the DW-MRI to be performed in the appropriate time&#xD;
             window, such as a medical condition or an MRI contraindication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marie Lannelongue Hospital (Paris, France)</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Hamburg-Eppendorf (Hamburg, Germany)</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondation Hôpital Saint-Joseph</investigator_affiliation>
    <investigator_full_name>Wolf Eilenberg</investigator_full_name>
    <investigator_title>Professor Stephan Haulon, Proessor Tilo Kölbel</investigator_title>
  </responsible_party>
  <keyword>Thoracic endovascular aortic repair</keyword>
  <keyword>Silent cerebral infarction</keyword>
  <keyword>Stroke</keyword>
  <keyword>Magnetic resonance imaging</keyword>
  <keyword>DW-MRI</keyword>
  <keyword>Aortic arch disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Infarction</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aneurysm, Aortic Arch</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04489277
org study id: INSERM UMR_S 999
nct id: NCT04489277
lead sponsor: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is the largest study to evaluate incidence and distribution of silent cerebral
      infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is
      the first cohort to include total endovascular arch repair and devices flushed with carbon
      dioxide (CO2) to prevent gaseous cerebral embolization.
Introduction. Poor data exist concerning the rate of silent cerebral ischemic events
      following endovascular treatment of the aortic arch. The objective of this work was to
      quantify these lesions using the STEP registry.

      Methods. This multicentre retrospective cohort study included consecutive patients treated
      with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted
      magnetic resonance imaging (DW-MRI) within 7 days after the procedure. DW-MRI was performed
      to identify the location and number of new silent brain infarctions (SBI), microbleeds ans
      general outcome of the patients.
observational model: Cohort
time perspective: Other
measure: frequency of silent cerebral infarcts on DW-MRI
time frame: 7 days
description: Primary outcomes were the frequency of silent cerebral infarcts on DW-MRI after endovascular arch procedures, and to identify the number, the distribution, and predictors of these lesions.
measure: perioperative ischemic stroke
time frame: 30 days
description: Secondary outcomes were perioperative ischemic stroke defined as a brain infarction of ischemic etiology which occurs during surgery or within 30 days after surgery, TIA, hemorrhagic stroke, 30-day mortality, spinal cord ischemia, length of stay and discharge disposition.
arm group label: Patients with Silent Brain Infarction
description: treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure with silent brain infarction
arm group label: Patients without Silent Brain Infarction
description: treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure without silent brain infarction
intervention type: Device
intervention name: Endovascular Arch Procedures
description: Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)
arm group label: Patients with Silent Brain Infarction
arm group label: Patients without Silent Brain Infarction
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
facility: 
country: France
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Fondation Hôpital Saint-Joseph
investigator full name: Wolf Eilenberg
investigator title: Professor Stephan Haulon, Proessor Tilo Kölbel
mesh term: Brain Infarction
mesh term: Aneurysm
mesh term: Aneurysm, Aortic Arch
mesh term: Infarction
sharing ipd: No