<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/NCT02971826</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0571</org_study_id>
    <secondary_id>2016-A01470-51</secondary_id>
    <nct_id>NCT02971826</nct_id>
  </id_info>
  <brief_title>Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke</brief_title>
  <acronym>REVIVE SE</acronym>
  <official_title>Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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 last marketed thrombectomy devices, named stentretriever, permit a better and faster&#xD;
      recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the&#xD;
      brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is&#xD;
      not widely use in Europe and in France. The objective of this study is to assess the interest&#xD;
      of using this device in the standard care of ischemic stroke in the radiology unit of the&#xD;
      hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will be&#xD;
      collected in order to determine whether or not this device is useful for the practice of the&#xD;
      radiology unit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of patients with a TICI score of 2b or 3 just after the thrombectomy</measure>
    <time_frame>up to 2 days</time_frame>
    <description>The TICI score is a grading system which evaluate the degree of reperfusion as seen on arteriography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.)</measure>
    <time_frame>up to 2 days</time_frame>
    <description>Review of the medical report which collected the devices used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc)</measure>
    <time_frame>Day 0</time_frame>
    <description>Review of the medical report which collected the acute treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to obtain the appropriate recanalization (TICI 2b or 3)</measure>
    <time_frame>At the end of the procedure - Day 0</time_frame>
    <description>Time of recanalization reported by the investigator on the medical report</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Thrombectomy using the REVIVETM SE device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thrombectomy using the REVIVETM SE device in patient with an ischemic stroke</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>REVIVETM SE thrombectomy</intervention_name>
    <description>Mechanical thrombectomy using the REVIVETM SE device in patient with an ischemic stroke due to an intracranial arterial occlusion</description>
    <arm_group_label>Thrombectomy using the REVIVETM SE device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with an ischemic stroke detected by Computed Tomography (CT) or Magnetic&#xD;
             Resonance Image (MRI)&#xD;
&#xD;
          -  Large proximal arterial occlusion : M1 segment of the Middle cerebral artery (MCA),&#xD;
             Internal Carotid Artery (ICA) or Basilar Artery (BA)&#xD;
&#xD;
          -  Last known well (without neurological symptoms) ≤ 8 hours of treatment initiation&#xD;
&#xD;
          -  Score NIHSS ≥4&#xD;
&#xD;
          -  Eligibility on an endovascular procedure using REVIVETM SE device&#xD;
&#xD;
          -  No opposition of the patient to participate at the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnostic cerebral imaging impossible&#xD;
&#xD;
          -  Distal occlusion&#xD;
&#xD;
          -  Tortuous vessel or other specificity preventing the access of device&#xD;
&#xD;
          -  Vessel diameter &lt; 1.5 mm&#xD;
&#xD;
          -  Known hypersensibility or allergy to nitinol&#xD;
&#xD;
          -  Subjects not covered by or having the right to social security&#xD;
&#xD;
          -  Deprivation of civil rights (guardianship, safeguard justice)&#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>Françis TURJMAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Françis TURJMAN, MD</last_name>
    <phone>4 7235 74 05</phone>
    <phone_ext>+33</phone_ext>
    <email>francis.turjman@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claire Jossan</last_name>
    <phone>4 27 86 66 90</phone>
    <phone_ext>+33</phone_ext>
    <email>claire.jossan@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospices Civils de Lyon - Neuroradiology unit</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Françis TURJMAN, MD</last_name>
      <phone>4 7235 74 05</phone>
      <phone_ext>+33</phone_ext>
      <email>francis.turjman@chu-lyon.fr</email>
    </contact>
    <contact_backup>
      <last_name>Claire Jossan</last_name>
      <phone>4 27 86 66 90</phone>
      <phone_ext>+33</phone_ext>
      <email>claire.jossan@chu-lyon.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Françis TURJMAN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul-Emile LABEYRIE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roberto RIVA, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Benjamin GORY, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>thrombectomy</keyword>
  <keyword>REVIVETM SE</keyword>
  <keyword>MRI</keyword>
  <keyword>Computed Tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02971826
org study id: 69HCL16_0571
secondary id: 2016-A01470-51
nct id: NCT02971826
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The last marketed thrombectomy devices, named stentretriever, permit a better and faster
      recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the
      brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is
      not widely use in Europe and in France. The objective of this study is to assess the interest
      of using this device in the standard care of ischemic stroke in the radiology unit of the
      hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will be
      collected in order to determine whether or not this device is useful for the practice of the
      radiology unit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: number of patients with a TICI score of 2b or 3 just after the thrombectomy
time frame: up to 2 days
description: The TICI score is a grading system which evaluate the degree of reperfusion as seen on arteriography
measure: Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.)
time frame: up to 2 days
description: Review of the medical report which collected the devices used
measure: Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc)
time frame: Day 0
description: Review of the medical report which collected the acute treatments
measure: Time to obtain the appropriate recanalization (TICI 2b or 3)
time frame: At the end of the procedure - Day 0
description: Time of recanalization reported by the investigator on the medical report
arm group label: Thrombectomy using the REVIVETM SE device
arm group type: Experimental
description: Thrombectomy using the REVIVETM SE device in patient with an ischemic stroke
intervention type: Device
intervention name: REVIVETM SE thrombectomy
description: Mechanical thrombectomy using the REVIVETM SE device in patient with an ischemic stroke due to an intracranial arterial occlusion
arm group label: Thrombectomy using the REVIVETM SE device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Françis TURJMAN
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: Françis TURJMAN, MD
phone: 4 7235 74 05
phone ext: +33
email: francis.turjman@chu-lyon.fr
last name: Claire Jossan
phone: 4 27 86 66 90
phone ext: +33
email: claire.jossan@chu-lyon.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No