<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/NCT03776877</url>
  </required_header>
  <id_info>
    <org_study_id>2017024F</org_study_id>
    <nct_id>NCT03776877</nct_id>
  </id_info>
  <brief_title>Endovascular Treatment in Ischemic Stroke Follow-up Evaluation</brief_title>
  <acronym>ETIS</acronym>
  <official_title>Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study like register with biomarkers samples for patient experiencing acute ischemic stroke,&#xD;
      to assess clinical outcomes and different factors that may affect the clinical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 26, 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>90 Days</target_duration>
  <primary_outcome>
    <measure>Clinical outcome</measure>
    <time_frame>Day 90</time_frame>
    <description>modified Rankin score (mRS), score 0 to 6 with 0 = no symptoms and 6 = death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy on reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)</measure>
    <time_frame>Day 1</time_frame>
    <description>Rate of complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy on revascularization (&gt;= mTICI 2b)</measure>
    <time_frame>Day 1</time_frame>
    <description>Time to achieve TICI 2b or better revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy on clinical outcome (mRS=0-1)</measure>
    <time_frame>Day 90</time_frame>
    <description>Rate of excellent functional outcome defined as a modified Rankin score (mRS) 0-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy on functional independence (mRS 0-2)</measure>
    <time_frame>Day 90</time_frame>
    <description>Rate of functional independence defined as a modified Rankin score 0-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemorrhage evaluated by imagery</measure>
    <time_frame>Day 0</time_frame>
    <description>Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematoma rate</measure>
    <time_frame>Day 1</time_frame>
    <description>Rate of parenchymal hematoma 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>Day 90</time_frame>
    <description>Rate of all-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Day 0</time_frame>
    <description>Rate of periprocedural complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASPECT (Alberta Stroke Program Early CT score)</measure>
    <time_frame>Day O</time_frame>
    <description>Measure by Axial imaging, 10-point quantitative topographic CT scan score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parametric imaging</measure>
    <time_frame>Day 0</time_frame>
    <description>Diffusion, volume clinical-diffusion mismatch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Imaging data</measure>
    <time_frame>Day 1</time_frame>
    <description>Angiographic imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood sampling for research purpose</measure>
    <time_frame>Day 0</time_frame>
    <description>Search of biomarkers of stroke etiology and recovery</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Stroke, Acute</condition>
  <arm_group>
    <arm_group_label>Arterial Ischemic Stroke (AIS)</arm_group_label>
    <description>All patients (prospective and retrospective) included will have to present an Arterial Ischemic Stroke (AIS) from a large cerebral vessel occlusion.&#xD;
The participation in the study will consist in:&#xD;
Plasmatic collection at the time of AIS, for study of plasma biomarkers&#xD;
Additional standardized blinded clinical evaluation at three months after the thrombectomy realized during a phone call, particularly via an assessment of the modified Rankin score.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with stroke treated by thrombectomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and older (i.e., candidates must have had their 18th birthday)&#xD;
&#xD;
          -  Neuroimaging demonstrates acute ischemic stroke with large vessel proximal with the&#xD;
             use of neuro-thrombectomy devices intended to restore blood flow&#xD;
&#xD;
          -  No upper or lower limits of the neurological severity at baseline (NIHSS).&#xD;
&#xD;
          -  With or without intravenous thrombolysis&#xD;
&#xD;
          -  Oral informed consent (patient and/or trustworthy person)&#xD;
&#xD;
        Non-inclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Patient benefiting from a legal protection&#xD;
&#xD;
          -  Non-membership of a national insurance scheme&#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>Bertrand Larpergue, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elisabeth Hulier-Ammar</last_name>
    <phone>+33146251175</phone>
    <email>drci-promotion@hopital-foch.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gaultier Marnat, MD</last_name>
      <email>gaultier.marnat@chu-bordeaux.fr</email>
    </contact>
    <investigator>
      <last_name>Gaultier Marnat, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuel TOUZE, PhD</last_name>
      <email>touze-e@chu-caen.fr</email>
    </contact>
    <investigator>
      <last_name>Emmanuel TOUZE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital le Kremlin-Bicètre - APHP</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent Spelle, MD</last_name>
      <email>laurent.spelle@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Laurent Spelle, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Dupuytren</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charbel MOUNAYER, MD</last_name>
      <email>charbel.mounayer@unilim.fr</email>
    </contact>
    <investigator>
      <last_name>Charbel MOUNAYER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Omer Eker, MD</last_name>
      <email>Omer.eker@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>Omer Eker, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cyril Dargazanli, MD</last_name>
      <email>cyril.dargazanli@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Cyril Darganzanli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Gory, MD</last_name>
      <email>b.gory@chu-nancy.fr</email>
    </contact>
    <investigator>
      <last_name>Benjamin Gory, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romain Bourcier, MD</last_name>
      <email>Romain.bourcier@chu-nantes.fr</email>
    </contact>
    <investigator>
      <last_name>Romain Bourcier, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frédéric CLARENCON, MD</last_name>
      <email>frederic.clarencon@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Frédéric CLARENCON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital SAINTE ANNE</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier NAGARRA, MD</last_name>
      <email>O.NAGGARA@ch-sainte-anne.fr</email>
    </contact>
    <investigator>
      <last_name>Olivier NAGARRA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondation Ophtalmique de Rotschild</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raphael Blanc, MD</last_name>
      <email>rblanc@fo-rothschild.fr</email>
    </contact>
    <investigator>
      <last_name>Raphael Blanc, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Christophe Ferre, MD</last_name>
      <email>Jean-christophe.FERRE@chu-rennes.fr</email>
    </contact>
    <investigator>
      <last_name>JC Ferre, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olzem OZKUL-WERMESTER, MD</last_name>
      <email>Ozlem.OzkulWermester@chu-rouen.fr</email>
    </contact>
    <investigator>
      <last_name>Olzem OZKUL-WERMESTER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bertrand Lapergue, MD</last_name>
      <phone>+33(0)1 46 25 73 43</phone>
      <email>b.lapergue@hopital-foch.org</email>
    </contact>
    <investigator>
      <last_name>Bertrand Lapergue, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain VIGUIER, MD</last_name>
      <email>viguier.a@chu-toulouse.fr</email>
    </contact>
    <investigator>
      <last_name>Alain VIGUIER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Bretagne Atlantique</name>
      <address>
        <city>Vannes</city>
        <zip>56017</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic 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/NCT03776877
org study id: 2017024F
nct id: NCT03776877
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Study like register with biomarkers samples for patient experiencing acute ischemic stroke,
      to assess clinical outcomes and different factors that may affect the clinical outcomes.
observational model: Cohort
time perspective: Other
measure: Clinical outcome
time frame: Day 90
description: modified Rankin score (mRS), score 0 to 6 with 0 = no symptoms and 6 = death.
measure: Efficacy on reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)
time frame: Day 1
description: Rate of complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)
measure: Efficacy on revascularization (>= mTICI 2b)
time frame: Day 1
description: Time to achieve TICI 2b or better revascularization
measure: Efficacy on clinical outcome (mRS=0-1)
time frame: Day 90
description: Rate of excellent functional outcome defined as a modified Rankin score (mRS) 0-1
measure: Efficacy on functional independence (mRS 0-2)
time frame: Day 90
description: Rate of functional independence defined as a modified Rankin score 0-2
measure: Hemorrhage evaluated by imagery
time frame: Day 0
description: Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan
measure: Hematoma rate
time frame: Day 1
description: Rate of parenchymal hematoma 2
measure: Mortality rate
time frame: Day 90
description: Rate of all-cause mortality
measure: Complication rate
time frame: Day 0
description: Rate of periprocedural complications
measure: ASPECT (Alberta Stroke Program Early CT score)
time frame: Day O
description: Measure by Axial imaging, 10-point quantitative topographic CT scan score
measure: Parametric imaging
time frame: Day 0
description: Diffusion, volume clinical-diffusion mismatch
measure: Imaging data
time frame: Day 1
description: Angiographic imaging
measure: Blood sampling for research purpose
time frame: Day 0
description: Search of biomarkers of stroke etiology and recovery
arm group label: Arterial Ischemic Stroke (AIS)
description: All patients (prospective and retrospective) included will have to present an Arterial Ischemic Stroke (AIS) from a large cerebral vessel occlusion.
The participation in the study will consist in:
Plasmatic collection at the time of AIS, for study of plasma biomarkers
Additional standardized blinded clinical evaluation at three months after the thrombectomy realized during a phone call, particularly via an assessment of the modified Rankin score.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bertrand Larpergue, MD
role: Principal Investigator
affiliation: Hopital Foch
last name: Elisabeth Hulier-Ammar
phone: +33146251175
email: drci-promotion@hopital-foch.com
facility: 
status: Recruiting
contact: 
investigator: 
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Active, not recruiting
country: France
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: No