<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/NCT03811769</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0173</org_study_id>
    <nct_id>NCT03811769</nct_id>
  </id_info>
  <brief_title>Large Stroke Therapy Evaluation</brief_title>
  <acronym>LASTE</acronym>
  <official_title>Evaluation of Acute Mechanical Revascularisation in Large Stroke (ASPECTS 0-5) With Large Vessel Occlusion Within 7 Hours After Stroke Onset or Last Known Well</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Stroke represents the fourth leading cause of death in industrialized nations, after heart&#xD;
      disease, cancer, and chronic lower respiratory disease. The overall burden of stroke will&#xD;
      rise dramatically in the next 20 years due to an ageing population. Approximately one-quarter&#xD;
      of the patients suffering a stroke die within one year after the initial event and stroke is&#xD;
      a leading cause of serious long-term disability. Acute ischemic stroke (AIS) due to large&#xD;
      vessel occlusion (LVO) is a potentially devastating event, with a poor prognosis in the&#xD;
      absence of timely revascularization. Whether in patients with large anterior circulation&#xD;
      stroke, direct mechanical intervention is equally effective, superior or inferior to bridging&#xD;
      thrombolysis remains a matter of debate.&#xD;
&#xD;
      Thus, this procedure, is now the recommended standard of care for selective patients with LVO&#xD;
      in the anterior circulation. When performed with newer generation devices (mainly stent&#xD;
      retrievers), more stringent imaging selection criteria and more efficient workflow than in&#xD;
      previous trials, significantly reduces disability rates after AIS caused by LVO in the&#xD;
      anterior circulation.&#xD;
&#xD;
      The STAIR (Stroke Treatment Academic Industry Roundtable) meeting aims to advance acute&#xD;
      stroke therapy development through collaboration between academia, industry, and regulatory&#xD;
      institutions. In pursuit of this goal and building on the available level I evidence of&#xD;
      benefit from endovascular therapy (EVT) in large vessel occlusion stroke, STAIR IX consensus&#xD;
      recommendations were developed that outline priorities for future research in EVT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The LASTE hypothesis is that patient harbouring a large ischemic core stroke at presentation,&#xD;
      may still benefit from mechanical thrombectomy, given the very poor natural history of&#xD;
      patient managed by a standalone medical therapy.&#xD;
&#xD;
      The threshold of ASPECTS 5 to set a benefit for treatment was inspired by initial large&#xD;
      medical trials using IV t-PA25-27 (Samurai-CT ALBERTA Score IV cohort). In the paradigm of&#xD;
      acute and complete reperfusion, radiographic infarct stroke volume may be partially&#xD;
      reversible and thus the resulting final infarct may be smaller compared to the one in&#xD;
      non-re-perfused patients who will consequently have poorer clinical outcomes. By now, large&#xD;
      core patients defined as ASPECTS 0-5 were excluded from most randomized clinical trials&#xD;
      resulting in a lack of unequivocal evidence of benefit in this patient population.&#xD;
&#xD;
      Analyses of several prospective cohorts suggest signals of benefit in favor of thrombectomy&#xD;
      in patients with large baseline core. In the prospective cohort ETIS, LAPERGUE et al reported&#xD;
      a rate of good outcome of 34% in the subgroup of patient with ASPECT 4-5. In the prospective&#xD;
      cohort analysis RECOST, a mean mRS score of 34% in a group of patient presenting ASPECT 0-5&#xD;
      treated with mechanical thrombectomy, versus 9% of good outcome in the medical group,&#xD;
      suggesting a benefit to treat LVO harbouring a large core. The strongest argument in favor of&#xD;
      benefit of EVT even in patients with large core is provided by the six completed randomized&#xD;
      endovascular stroke trials. These trials did prove that Combined Approach Mechanical + IV&#xD;
      t-PA, is superior to standalone IV lytics, mRs score ≤ 2 ranging from 33% and up to 72%, but&#xD;
      Large Core Infarction were largely excluded. Nonetheless a pooled analysis of these trials&#xD;
      revealed that a minority of patients with large baseline core were still randomized. In MR&#xD;
      CLEAN study, despite no exclusion criteria defined in the initial protocol, the median ASPECT&#xD;
      score of the cohort was 9 out of 10. In SWIFT-PRIME study, the mean ASPECT score of the&#xD;
      cohort was 7, and in REVASCAT study it was 6.8.&#xD;
&#xD;
      The LASTE protocol &quot;Large Stroke Therapy Evaluation&quot; aims to study the efficacy and safety of&#xD;
      mechanical thrombectomy in the acute phase of cerebral infarction less than 7 hours for&#xD;
      patients with a large volume of necrosis defined by a score ASPECT from 0 to 5. The patients&#xD;
      will be followed 6 months after the stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 7, 2019</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of functional outcome</measure>
    <time_frame>3 months</time_frame>
    <description>Shift on the Modified Rankin Scale (mRS) at 90 days in experimental group vs the control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of all-cause mortality at 90 days</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation of mortality at 90 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of symptomatic intracerebral hemorrhage</measure>
    <time_frame>1 day</time_frame>
    <description>Incidence of symptomatic intracerebral hemorrhage according to HEIDELBERG at imaging at 24 (-6/+12) hours post randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deterioration of patient's condition</measure>
    <time_frame>6 months</time_frame>
    <description>National Institutes of Health Stroke Scale (NIHSS) ≥ 10 points during hospitalization. This scale is construed by 15 items and the minimum score is 1 and the maximum score is 20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of procedure/device-related adverse events</measure>
    <time_frame>1 day</time_frame>
    <description>Incidence of procedure/device-related adverse events (in patients treated by mechanical treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the degree of disability</measure>
    <time_frame>6 months</time_frame>
    <description>The degree of disability at 180 days (shift on the mRS combining scores of 5 and 6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of functional outcome (mRS 0-2)</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Rate of patients with a good functional outcome at 90 days and 180 days, defined as mRS 0-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of functional outcome (mRS 0-3)</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Rate of patients with a favorable outcome at 90 and 180 days, defined as Modified Rankin Scale (mRS) 0-3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of utility weighted Modified Rankin Scale (mRS)</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Distribution of utility weighted mRS (UW mRS) at 90 and 180 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of the patient</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Quality of life at 90 and 180 days assessed by EuroQol 5D-5L (5-level EQ-5-Dimension) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with secondary decompressive craniectomy</measure>
    <time_frame>6 months</time_frame>
    <description>Rate of patients with secondary decompressive craniectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of patient's condition</measure>
    <time_frame>7 days</time_frame>
    <description>Rate of patients with &quot;early good response&quot; at Day 5-7/Discharge (whichever is earlier), defined as a NIHSS drop of ≥ 8 points from baseline or NIHSS score 0 or 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medico-economic study</measure>
    <time_frame>6 months</time_frame>
    <description>Cost-effectiveness analysis (number of patients functionally independent : mRS =&lt; 2), cost of devices and drugs, staff hourly cost, operating room cost</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">335</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Best Medical Therapy (BMT)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Best treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mechanical Thrombectomy (MT)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Endovascular treatment (thrombectomy) associated with the best medical treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Medical Therapy</intervention_name>
    <description>The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to local standards of care but may NOT include any intra-arterial therapies.</description>
    <arm_group_label>Best Medical Therapy (BMT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mechanical Thrombectomy</intervention_name>
    <description>MT in the Experimental Arm can be performed with any thrombectomy (CE labeled) device usually used at study site. For the subjects randomized to the MT plus BMT arm start of treatment is defined as the date and time of groin puncture (arterial access).</description>
    <arm_group_label>Mechanical Thrombectomy (MT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is ≥ 18 years old at inclusion (no upper age limit)&#xD;
&#xD;
          2. Clinical signs consistent with acute ischemic stroke with symptoms onset or time last&#xD;
             known well (TLKW) ≤ 6.5 h from randomization (With the goal of remaining within 7&#xD;
             hours from TLKW till treatment), or with negative FLAIR on MRI, if TLKW is unknown&#xD;
&#xD;
          3. Proven Large Ischemic Core defined as: ASPECT Score 0 to 5 on non-contrast CT or&#xD;
             Diffusion Weighted Imaging (DWI)-MRI. In patients ≥ 80 years : ASPECT score 4 or 5.&#xD;
&#xD;
             (ASPECTS on MRI will be calculated in the following way: an ASPECTS region will&#xD;
             considered to be affected if &gt; 30% of its area demonstrates restricted diffusion)&#xD;
&#xD;
          4. Proved anterior circulation intracranial large vessel occlusion on CTA or MRA&#xD;
             (intracranial ICA, M1, M1-M2)&#xD;
&#xD;
          5. Patient or patient's representative has received information about the study and has&#xD;
             signed and dated the appropriate Informed Consent Form, or fulfilling the criteria for&#xD;
             emergent consent&#xD;
&#xD;
          6. Selection imaging performed maximum 3 hours from randomization&#xD;
&#xD;
          7. Anticipated possibility to start the procedure (arterial access) within 30 minutes&#xD;
             after randomization&#xD;
&#xD;
          8. Pre stroke mRS ≤ 1&#xD;
&#xD;
          9. Subjects receiving antiaggregant and/or anticoagulant agents (at any mode of&#xD;
             administration) within the last 24 hours from screening are eligible for participation&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          1. Anticipated impossibility to start the procedure (arterial access) within 30 minutes&#xD;
             after randomization.&#xD;
&#xD;
          2. Known absence of vascular access.&#xD;
&#xD;
          3. Known contrast or endovascular product life-threatening allergy.&#xD;
&#xD;
          4. Female who is known to be pregnant or lactating at time of admission&#xD;
&#xD;
          5. Patient presents severe or fatal co-morbidities or life expectancy under 6 months that&#xD;
             will likely interfere with the improvement or follow-up or that will render the&#xD;
             procedure unlikely to benefit the patient.&#xD;
&#xD;
          6. Patient unable to present or be available for follow-up.&#xD;
&#xD;
          7. Pre-existing neurological or psychiatric disease that would confound the neurological&#xD;
             or functional evaluations.&#xD;
&#xD;
          8. Evidence of vessel recanalization prior to randomization.&#xD;
&#xD;
          9. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes&#xD;
             obtaining an accurate baseline NIHSS assessment.&#xD;
&#xD;
         10. Current participation in another investigational drug study.&#xD;
&#xD;
         11. Suspicion of aortic dissection based on medical history, clinical evaluation or/and&#xD;
             imaging.&#xD;
&#xD;
         12. Major patients under guardianship.&#xD;
&#xD;
        Imaging Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of intracranial haemorrhage on CT/MRI&#xD;
&#xD;
          2. Excessive tortuosity of cervical vessels on CTA/MRA that would likely result in&#xD;
             unstable access platform&#xD;
&#xD;
          3. High Suspicion of underlying intracranial stenosis on CTA/MRA/digital subtraction&#xD;
             angiography (DSA)&#xD;
&#xD;
          4. Suspected cerebral vascular disease (e.g. vasculitis) based on medical history and&#xD;
             CTA/MRA/DSA&#xD;
&#xD;
          5. Presumed calcified Embolus or Intracranial Stenosis decompensation&#xD;
&#xD;
          6. Intracranial stent implanted in the same vascular territory that would preclude the&#xD;
             safe deployment/removal of the stentriever device&#xD;
&#xD;
          7. Occlusions in multiple vascular territories (e.g.: bilateral anterior circulation, or&#xD;
             anterior circulation/vertebrobasilar system) confirmed on CTA/MRA/DSA.&#xD;
&#xD;
          8. Significant mass effect with midline shift as confirmed on CT/MRI&#xD;
&#xD;
          9. Any cervical ICA lesion (Tandem), that requires stent placement&#xD;
&#xD;
         10. Isolated proximal cervical ICA occlusions&#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>Vincent COSTALAT, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Gui de Chauliac</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Caroline ARQUIZAN, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Gui de Chauliac</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bertrand LAPERGUE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Foch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tudor JOVIN, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cooper Neurological Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Gui De Chauliac</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>June 5, 2023</last_update_submitted>
  <last_update_submitted_qc>June 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mechanical thrombectomy</keyword>
  <keyword>Stroke</keyword>
  <keyword>Proximal intracranial arterial occlusions</keyword>
  <keyword>Large vessel occlusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT03811769
org study id: RECHMPL18_0173
nct id: NCT03811769
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke represents the fourth leading cause of death in industrialized nations, after heart
      disease, cancer, and chronic lower respiratory disease. The overall burden of stroke will
      rise dramatically in the next 20 years due to an ageing population. Approximately one-quarter
      of the patients suffering a stroke die within one year after the initial event and stroke is
      a leading cause of serious long-term disability. Acute ischemic stroke (AIS) due to large
      vessel occlusion (LVO) is a potentially devastating event, with a poor prognosis in the
      absence of timely revascularization. Whether in patients with large anterior circulation
      stroke, direct mechanical intervention is equally effective, superior or inferior to bridging
      thrombolysis remains a matter of debate.

      Thus, this procedure, is now the recommended standard of care for selective patients with LVO
      in the anterior circulation. When performed with newer generation devices (mainly stent
      retrievers), more stringent imaging selection criteria and more efficient workflow than in
      previous trials, significantly reduces disability rates after AIS caused by LVO in the
      anterior circulation.

      The STAIR (Stroke Treatment Academic Industry Roundtable) meeting aims to advance acute
      stroke therapy development through collaboration between academia, industry, and regulatory
      institutions. In pursuit of this goal and building on the available level I evidence of
      benefit from endovascular therapy (EVT) in large vessel occlusion stroke, STAIR IX consensus
      recommendations were developed that outline priorities for future research in EVT.
The LASTE hypothesis is that patient harbouring a large ischemic core stroke at presentation,
      may still benefit from mechanical thrombectomy, given the very poor natural history of
      patient managed by a standalone medical therapy.

      The threshold of ASPECTS 5 to set a benefit for treatment was inspired by initial large
      medical trials using IV t-PA25-27 (Samurai-CT ALBERTA Score IV cohort). In the paradigm of
      acute and complete reperfusion, radiographic infarct stroke volume may be partially
      reversible and thus the resulting final infarct may be smaller compared to the one in
      non-re-perfused patients who will consequently have poorer clinical outcomes. By now, large
      core patients defined as ASPECTS 0-5 were excluded from most randomized clinical trials
      resulting in a lack of unequivocal evidence of benefit in this patient population.

      Analyses of several prospective cohorts suggest signals of benefit in favor of thrombectomy
      in patients with large baseline core. In the prospective cohort ETIS, LAPERGUE et al reported
      a rate of good outcome of 34% in the subgroup of patient with ASPECT 4-5. In the prospective
      cohort analysis RECOST, a mean mRS score of 34% in a group of patient presenting ASPECT 0-5
      treated with mechanical thrombectomy, versus 9% of good outcome in the medical group,
      suggesting a benefit to treat LVO harbouring a large core. The strongest argument in favor of
      benefit of EVT even in patients with large core is provided by the six completed randomized
      endovascular stroke trials. These trials did prove that Combined Approach Mechanical + IV
      t-PA, is superior to standalone IV lytics, mRs score ≤ 2 ranging from 33% and up to 72%, but
      Large Core Infarction were largely excluded. Nonetheless a pooled analysis of these trials
      revealed that a minority of patients with large baseline core were still randomized. In MR
      CLEAN study, despite no exclusion criteria defined in the initial protocol, the median ASPECT
      score of the cohort was 9 out of 10. In SWIFT-PRIME study, the mean ASPECT score of the
      cohort was 7, and in REVASCAT study it was 6.8.

      The LASTE protocol "Large Stroke Therapy Evaluation" aims to study the efficacy and safety of
      mechanical thrombectomy in the acute phase of cerebral infarction less than 7 hours for
      patients with a large volume of necrosis defined by a score ASPECT from 0 to 5. The patients
      will be followed 6 months after the stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Evaluation of functional outcome
time frame: 3 months
description: Shift on the Modified Rankin Scale (mRS) at 90 days in experimental group vs the control group
measure: Incidence of all-cause mortality at 90 days
time frame: 3 months
description: Evaluation of mortality at 90 days
measure: Incidence of symptomatic intracerebral hemorrhage
time frame: 1 day
description: Incidence of symptomatic intracerebral hemorrhage according to HEIDELBERG at imaging at 24 (-6/+12) hours post randomization
measure: Deterioration of patient's condition
time frame: 6 months
description: National Institutes of Health Stroke Scale (NIHSS) ≥ 10 points during hospitalization. This scale is construed by 15 items and the minimum score is 1 and the maximum score is 20.
measure: Incidence of procedure/device-related adverse events
time frame: 1 day
description: Incidence of procedure/device-related adverse events (in patients treated by mechanical treatment)
measure: Evaluation of the degree of disability
time frame: 6 months
description: The degree of disability at 180 days (shift on the mRS combining scores of 5 and 6)
measure: Evaluation of functional outcome (mRS 0-2)
time frame: 3 and 6 months
description: Rate of patients with a good functional outcome at 90 days and 180 days, defined as mRS 0-2
measure: Evaluation of functional outcome (mRS 0-3)
time frame: 3 and 6 months
description: Rate of patients with a favorable outcome at 90 and 180 days, defined as Modified Rankin Scale (mRS) 0-3
measure: Distribution of utility weighted Modified Rankin Scale (mRS)
time frame: 3 and 6 months
description: Distribution of utility weighted mRS (UW mRS) at 90 and 180 days
measure: Quality of life of the patient
time frame: 3 and 6 months
description: Quality of life at 90 and 180 days assessed by EuroQol 5D-5L (5-level EQ-5-Dimension) scale
measure: Rate of patients with secondary decompressive craniectomy
time frame: 6 months
description: Rate of patients with secondary decompressive craniectomy
measure: Improvement of patient's condition
time frame: 7 days
description: Rate of patients with "early good response" at Day 5-7/Discharge (whichever is earlier), defined as a NIHSS drop of ≥ 8 points from baseline or NIHSS score 0 or 1
measure: Medico-economic study
time frame: 6 months
description: Cost-effectiveness analysis (number of patients functionally independent : mRS =< 2), cost of devices and drugs, staff hourly cost, operating room cost
arm group label: Best Medical Therapy (BMT)
arm group type: Other
description: Best treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration
arm group label: Mechanical Thrombectomy (MT)
arm group type: Other
description: Endovascular treatment (thrombectomy) associated with the best medical treatment
intervention type: Other
intervention name: Best Medical Therapy
description: The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to local standards of care but may NOT include any intra-arterial therapies.
arm group label: Best Medical Therapy (BMT)
intervention type: Procedure
intervention name: Mechanical Thrombectomy
description: MT in the Experimental Arm can be performed with any thrombectomy (CE labeled) device usually used at study site. For the subjects randomized to the MT plus BMT arm start of treatment is defined as the date and time of groin puncture (arterial access).
arm group label: Mechanical Thrombectomy (MT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vincent COSTALAT, PU-PH
role: Principal Investigator
affiliation: Hôpital Gui de Chauliac
last name: Caroline ARQUIZAN, PH
role: Principal Investigator
affiliation: Hôpital Gui de Chauliac
last name: Bertrand LAPERGUE
role: Principal Investigator
affiliation: Hôpital Foch
last name: Tudor JOVIN, PU-PH
role: Principal Investigator
affiliation: Cooper Neurological Institute
facility: 
country: France
responsible party type: Sponsor
mesh term: Stroke