<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/NCT02216565</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00519-38</org_study_id>
    <nct_id>NCT02216565</nct_id>
  </id_info>
  <brief_title>Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase</brief_title>
  <acronym>EASY</acronym>
  <official_title>Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial aims at comparing two strategies currently used to address acute ischemic stroke&#xD;
      of the middle cerebral artery : medical treatment without endovascular treatment on the one&#xD;
      hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of&#xD;
      the strategies will be assessed in terms of early neurological clinical recovery.&#xD;
&#xD;
      The study will focus on three particular situations : (1) tandem internal carotid and middle&#xD;
      cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis&#xD;
      because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended&#xD;
      because of a delay superior to 4.5 hours.&#xD;
&#xD;
      The hypothesis to be tested is that medical approach plus endovascular treatment is superior&#xD;
      to medical treatment alone&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    After results of other studies published : EASY study became lapsed&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2014</start_date>
  <completion_date type="Actual">August 24, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in NIHSS score after 24h</measure>
    <time_frame>24 hours</time_frame>
    <description>Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and h24 (t1) calculated as follow :&#xD;
[NIHSS(t0) - NIHSS(t1)] / NIHSS(t0)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in NIHSS score after 7 days</measure>
    <time_frame>7 days</time_frame>
    <description>Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and day7 (t2) calculated as follow :&#xD;
[NIHSS(t0) - NIHSS(t2)] / NIHSS(t0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional recovery after 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>modified Rankin Score (mRS) after 3 months (&quot;positive recovery&quot; if mRS &lt;=2, &quot;excellent recovery&quot; if mRS&lt;=1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatality within 7 days</measure>
    <time_frame>7 days</time_frame>
    <description>Proportion of patients deceased within seven days after stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatality within 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of patients deceased within 3 months after stroke</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Stroke, Acute</condition>
  <arm_group>
    <arm_group_label>Medical treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Conventional medical non-interventional treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endovascular treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Conventional medical treatment plus endovascular treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hospitalization in specialized neuro-vascular unit</intervention_name>
    <arm_group_label>Endovascular treatment</arm_group_label>
    <arm_group_label>Medical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alteplase if patient is eligible</intervention_name>
    <description>Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)</description>
    <arm_group_label>Endovascular treatment</arm_group_label>
    <arm_group_label>Medical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supportive care</intervention_name>
    <description>Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition</description>
    <arm_group_label>Endovascular treatment</arm_group_label>
    <arm_group_label>Medical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endovascular treatment</intervention_name>
    <description>Recanalization treatment (thrombectomy / intraarterial thrombolysis)</description>
    <arm_group_label>Endovascular treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Radiologically proven acute proximal occlusion of middle cerebral artery&#xD;
&#xD;
        AND one of the three following :&#xD;
&#xD;
          1. tandem internal carotid / middle cerebral artery occlusion&#xD;
&#xD;
          2. intravenous thrombolysis contraindicated because of high risk of haemorrhage&#xD;
&#xD;
          3. intravenous thrombolysis not possible because of delay &gt; 4.5 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impossibility to perform endovascular recanalization within 6h&#xD;
&#xD;
          -  Clinically minor stroke (NIHSS score below 5 at baseline)&#xD;
&#xD;
          -  Extended cerebral infarction&#xD;
&#xD;
          -  Severe comorbidity&#xD;
&#xD;
          -  Life expectancy below 3 months before stroke&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  modified Rankin Score superior to 2 before stroke&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>82 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc-Antoine Labeyrie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Lariboisiere, Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michel Piotin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Ophtalmologique Adolphe de Rothschild, Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Henri Mondor</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondation Ophtalmologique Adolphe de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>December 4, 2017</last_update_submitted>
  <last_update_submitted_qc>December 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Endovascular treatment</keyword>
  <keyword>Tandem carotid occlusions</keyword>
  <keyword>Fibrinolysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Plasminogen Activator</mesh_term>
  </intervention_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/NCT02216565
org study id: 2014-A00519-38
nct id: NCT02216565
lead sponsor: 
has dmc: Yes
This trial aims at comparing two strategies currently used to address acute ischemic stroke
      of the middle cerebral artery : medical treatment without endovascular treatment on the one
      hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of
      the strategies will be assessed in terms of early neurological clinical recovery.

      The study will focus on three particular situations : (1) tandem internal carotid and middle
      cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis
      because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended
      because of a delay superior to 4.5 hours.

      The hypothesis to be tested is that medical approach plus endovascular treatment is superior
      to medical treatment alone
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in NIHSS score after 24h
time frame: 24 hours
description: Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and h24 (t1) calculated as follow :
[NIHSS(t0) - NIHSS(t1)] / NIHSS(t0)
measure: Improvement in NIHSS score after 7 days
time frame: 7 days
description: Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and day7 (t2) calculated as follow :
[NIHSS(t0) - NIHSS(t2)] / NIHSS(t0)
measure: Functional recovery after 3 months
time frame: 3 months
description: modified Rankin Score (mRS) after 3 months ("positive recovery" if mRS <=2, "excellent recovery" if mRS<=1)
measure: Fatality within 7 days
time frame: 7 days
description: Proportion of patients deceased within seven days after stroke
measure: Fatality within 3 months
time frame: 3 months
description: Proportion of patients deceased within 3 months after stroke
arm group label: Medical treatment
arm group type: Other
description: Conventional medical non-interventional treatment
arm group label: Endovascular treatment
arm group type: Other
description: Conventional medical treatment plus endovascular treatment
intervention type: Other
intervention name: Hospitalization in specialized neuro-vascular unit
arm group label: Endovascular treatment
arm group label: Medical treatment
intervention type: Drug
intervention name: Alteplase if patient is eligible
description: Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)
arm group label: Endovascular treatment
arm group label: Medical treatment
intervention type: Other
intervention name: Supportive care
description: Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition
arm group label: Endovascular treatment
arm group label: Medical treatment
intervention type: Procedure
intervention name: Endovascular treatment
description: Recanalization treatment (thrombectomy / intraarterial thrombolysis)
arm group label: Endovascular treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 82 Years
healthy volunteers: No
last name: Marc-Antoine Labeyrie, MD
role: Principal Investigator
affiliation: Hopital Lariboisiere, Paris
last name: Michel Piotin, MD
role: Principal Investigator
affiliation: Fondation Ophtalmologique Adolphe de Rothschild, Paris
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Stroke
mesh term: Thrombosis
mesh term: Tissue Plasminogen Activator