<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/NCT02216643</url>
  </required_header>
  <id_info>
    <org_study_id>22042613.6.1001.5327</org_study_id>
    <nct_id>NCT02216643</nct_id>
  </id_info>
  <brief_title>EndoVascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke</brief_title>
  <acronym>RESILIENT</acronym>
  <official_title>Randomization of Endovascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke Due to Large VEssel OcclusioN Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Penumbra Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>iSchemaView, Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brainomix Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a&#xD;
      sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with&#xD;
      stentriever and/or Thromboaspiration versus medical management alone. Randomization will be&#xD;
      done under a minimization process using age, baseline NIHSS, use of IV tpa, vessel occlusion&#xD;
      site and hospital. To evaluate the hypothesis that mechanical thrombectomy is superior to&#xD;
      medical management alone in achieving more favorable outcomes in the distribution of the&#xD;
      modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel&#xD;
      ischemic stroke &lt;8 hours from symptom onset. Subjects are either ineligible for IV alteplase&#xD;
      or have received IV alteplase therapy without recanalization. Sample size is projected to be&#xD;
      690 patients for a difference in treatment effect of 10%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with acute ischemic stroke related to anterior circulation large vessel occlusion&#xD;
      will be randomized up to 8 hours from symptoms onset in both arms (mechanical thrombectomy&#xD;
      versus medical management alone). Subjects are either ineligible for IV alteplase or have&#xD;
      received IV alteplase therapy without recanalization. They will be admitted at acute stroke&#xD;
      units in Brazil (or ICU if needed) and treated following international guidelines.&#xD;
      Concomitant medications and non-pharmacological therapies will be recorded. A maximum of six&#xD;
      attempts to retrieve the thrombus in a single vessel can be made. No additional treatment&#xD;
      will be allowed either with Intrarterial tPA, mechanical devices or angioplasty/stenting.&#xD;
&#xD;
      The primary endpoint will be distribution of the modified Rankin Scale scores at 90 days&#xD;
      (shift analysis) as evaluated by two separate assessors who are blinded to treatment&#xD;
&#xD;
      Interim Analysis The sample size for this Phase III Trial is projected to be 690 subjects.&#xD;
      For interim analyses, the method of Lan and DeMets will be used to allocate alpha via the&#xD;
      power family method with φ (phi) equal to 1 for the assessment of efficacy and futility,&#xD;
      respectively after the first 174, 346 and 518 patients enrolled have completed the 90-day&#xD;
      follow-up. The interval may be more frequent if requested by the Data and Safety Monitoring&#xD;
      Board (DSMB). At interim analysis, in case the stopping boundaries are crossed the DSMB may&#xD;
      recommend stopping the study either for better efficacy of the tested treatment either for&#xD;
      futility. Other factors, such as safety, will be taken into consideration by the DSMB in the&#xD;
      decision to stop the study. When considering stopping the trial for safety reasons, the DSMB&#xD;
      will be instructed to consider both mortality (mRS=6) and severe dependency (mRS=5) at 3&#xD;
      months as one single outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distribution of the modified Rankin Scale scores (shift analysis)</measure>
    <time_frame>90 days</time_frame>
    <description>Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors who are blinded to treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional independence (modified Rankin Score ≤ 2)</measure>
    <time_frame>90 days</time_frame>
    <description>Functional independence measured by modified Rankin Score ≤ 2 in 90 days in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infarct Burden at 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>ASPECTS change from baseline to 24 hours on CT or MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dramatic early favorable response</measure>
    <time_frame>24 hours</time_frame>
    <description>defined as an NIHSS score 0-2 or a NIHSS score decrease of ≥8 from baseline at 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness</measure>
    <time_frame>Life-time horizon perspective</time_frame>
    <description>Cost effectiveness analysis of interventional therapy vs medical therapy alone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life analysis</measure>
    <time_frame>3 months, 6 months, 1 year</time_frame>
    <description>Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and one year, between interventional therapy vs medical therapy alone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vessel recanalization at 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>Vessel recanalization evaluated by CT angiography (CTA) or MR angiography (MRA) at 24 hours in both treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful recanalization at the end of procedure</measure>
    <time_frame>immediatelly after procedure (only thrombectomy arm)</time_frame>
    <description>defined as a grade of 2b or 3 (indicating reperfusion of &gt;50% of the affected territory) on the modified Thrombolysis in Cerebral Infarction (mTICI) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days</time_frame>
    <description>Mortality at 90 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic Intracranial hemorrhage</measure>
    <time_frame>24 hours</time_frame>
    <description>Clinically significant Intracranial hemorrhage (ICH) rates at 24 (-2/+12) hours. All intracerebral hemorrhages will be classified by a central core-lab using the ECASS criteria for CT evaluation. Symptomatic ICH will be defined as per the SITS-MOST definition: deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans. The incidence of any asymptomatic hemorrhage measured at 24 (-2/+12) hours will also be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure related complications</measure>
    <time_frame>During the procedure</time_frame>
    <description>Complications occurring during the procedure will be evaluated: distal embolization in a new territory, arterial dissection, arterial perfuration, groin hematoma</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">221</enrollment>
  <condition>Stroke</condition>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>thrombectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mechanical thrombectomy with stentriever Solitaire FR® and/or thromboaspiration with Penumbra System® in patients with large vessel occlusion in cerebral anterior circulation vessels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>best medical treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>best medical treatment in patients with acute ischemic stroke with anterior circulation large vessel occlusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thrombectomy</intervention_name>
    <description>Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever Solitaire FR® and/or thromboaspiration with Penumbra System® versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting.</description>
    <arm_group_label>thrombectomy</arm_group_label>
    <other_name>Endovascular treatment</other_name>
    <other_name>Intrarterial treatment</other_name>
    <other_name>Endovascular revascularization</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stentriever Solitaire FR® or Penumbra System®</intervention_name>
    <description>Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting.</description>
    <arm_group_label>thrombectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the&#xD;
             treatment is contraindicated (e.g., subject presents beyond recommended time from&#xD;
             symptom onset), or where patient has received IV thrombolytic therapy without clinical&#xD;
             improvement.&#xD;
&#xD;
          2. No significant pre-stroke functional disability (mRS ≤ 1)&#xD;
&#xD;
          3. Baseline NIHSS score obtained prior to randomization must be equal or higher than 8&#xD;
             points&#xD;
&#xD;
          4. Age ≥18 years&#xD;
&#xD;
          5. Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions) and/or&#xD;
             MCA-M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA or&#xD;
             angiogram, with or without concomitant cervical carotid occlusion or stenosis.&#xD;
&#xD;
          6. Patient treatable within eight hours of symptom onset. Symptoms onset is defined as&#xD;
             point in time the patient was last seen well (at baseline). Treatment start is defined&#xD;
             as groin puncture.&#xD;
&#xD;
          7. Informed consent obtained from patient or acceptable patient surrogate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant&#xD;
             therapy with INR &gt; 3.0&#xD;
&#xD;
          2. Baseline platelet count &lt; 30.000/µL&#xD;
&#xD;
          3. Baseline blood glucose of &lt; 50mg/dL or &gt; 400mg/dl&#xD;
&#xD;
          4. Severe, sustained hypertension (SBP &gt; 185 mm Hg or DBP &gt; 110 mm Hg) NOTE: If the blood&#xD;
             pressure can be successfully reduced and maintained at the acceptable level using AHA&#xD;
             guidelines recommended medication (including iv antihypertensive drips), the patient&#xD;
             can be enrolled.&#xD;
&#xD;
          5. Patients in coma (NIHSS item of consciousness &gt;1) (Intubated patients for transfer&#xD;
             could be randomized only in case an NIHSS is obtained by a neurologist prior&#xD;
             transportation).&#xD;
&#xD;
          6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS&#xD;
&#xD;
          7. Serious, advanced, or terminal illness with anticipated life expectancy of less than&#xD;
             one year.&#xD;
&#xD;
          8. History of life threatening allergy (more than rash) to contrast medium&#xD;
&#xD;
          9. Subjects who has received IV t-PA treatment beyond 4,5 hours from the beginning of the&#xD;
             symptoms&#xD;
&#xD;
         10. Woman of childbearing potential who is known to be pregnant or lactating or who has a&#xD;
             positive pregnancy test on admission.&#xD;
&#xD;
         11. Subject participating in a study involving an investigational drug or device that&#xD;
             would impact this study.&#xD;
&#xD;
         12. Cerebral vasculitis&#xD;
&#xD;
         13. Patients with a pre-existing neurological or psychiatric disease that would confound&#xD;
             the neurological or functional evaluations, mRS score at baseline must be ≤1. This&#xD;
             excludes patients who are severely demented, require constant assistance in a nursing&#xD;
             home type setting or who live at home but are not fully independent in activities of&#xD;
             daily living (toileting, dressing, eating, cooking and preparing meals, etc.)&#xD;
&#xD;
         14. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor&#xD;
             from overseas).&#xD;
&#xD;
         15. Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of &lt;6 on NCCT,&#xD;
             or &lt;5 on DWI MRI. The use of CTP or MRI perfusion is optional.&#xD;
&#xD;
         16. Collaterals with malignant profile on CTA (without colateral circulation on CTA)&#xD;
&#xD;
         17. CT or MR evidence of hemorrhage (the presence of GRE microbleeds is allowed).&#xD;
&#xD;
         18. Significant mass effect with midline shift.&#xD;
&#xD;
         19. Evidence of ipsilateral carotid occlusion, high grade stenosis or arterial dissection&#xD;
             in the extracranial or petrous segment of the internal carotid artery that cannot be&#xD;
             treated or will prevent access to the intracranial clot or excessive tortuosity of&#xD;
             cervical vessels precluding device delivery/deployment&#xD;
&#xD;
         20. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior&#xD;
             circulation, or anterior/posterior circulation)&#xD;
&#xD;
         21. Evidence of intracranial tumor (except small meningioma).&#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>Raul Nogueira, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sheila CO Martins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Geral Roberto Santos</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Geral de Fortaleza/SUS</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceará</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Base do Distrito Federal</name>
      <address>
        <city>Brasília</city>
        <state>DF</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Estadual Central</name>
      <address>
        <city>Vitória</city>
        <state>Espírito Santo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas da Universidade Federal do Paraná</name>
      <address>
        <city>Curitiba</city>
        <state>Paraná</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São José do Avaí</name>
      <address>
        <city>Itaperuna</city>
        <state>Rio De Janeiro</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNIÃO BRASILEIRA DE EDUCAÇÃO E ASSISTENCIA, Hospital São Lucas PUCRS</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Neurologica e Neurocirurgica de Joinville S/S Ltda</name>
      <address>
        <city>Joinville</city>
        <state>Santa Catarina</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Governador Celso Ramos</name>
      <address>
        <city>Florianópolis</city>
        <state>SC</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irmandade da Santa Casa de Misericórdia</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas da Faculdade de Medicina de Botucatu</name>
      <address>
        <city>Botucatu</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas - UNICAMP</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Ribeirão Preto</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de São Paulo - UNIFESP/EPM</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2020</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>February 16, 2020</last_update_submitted>
  <last_update_submitted_qc>February 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Clinicas de Porto Alegre</investigator_affiliation>
    <investigator_full_name>SHEILA CRISTINA OURIQUES MARTINS</investigator_full_name>
    <investigator_title>MD, PHD, Stroke Neurologist</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Ischemic Stroke</keyword>
  <keyword>Thrombectomy</keyword>
  <keyword>Reperfusion Therapy</keyword>
  <keyword>Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</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/NCT02216643
org study id: 22042613.6.1001.5327
nct id: NCT02216643
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a
      sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with
      stentriever and/or Thromboaspiration versus medical management alone. Randomization will be
      done under a minimization process using age, baseline NIHSS, use of IV tpa, vessel occlusion
      site and hospital. To evaluate the hypothesis that mechanical thrombectomy is superior to
      medical management alone in achieving more favorable outcomes in the distribution of the
      modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel
      ischemic stroke <8 hours from symptom onset. Subjects are either ineligible for IV alteplase
      or have received IV alteplase therapy without recanalization. Sample size is projected to be
      690 patients for a difference in treatment effect of 10%.
Patients with acute ischemic stroke related to anterior circulation large vessel occlusion
      will be randomized up to 8 hours from symptoms onset in both arms (mechanical thrombectomy
      versus medical management alone). Subjects are either ineligible for IV alteplase or have
      received IV alteplase therapy without recanalization. They will be admitted at acute stroke
      units in Brazil (or ICU if needed) and treated following international guidelines.
      Concomitant medications and non-pharmacological therapies will be recorded. A maximum of six
      attempts to retrieve the thrombus in a single vessel can be made. No additional treatment
      will be allowed either with Intrarterial tPA, mechanical devices or angioplasty/stenting.

      The primary endpoint will be distribution of the modified Rankin Scale scores at 90 days
      (shift analysis) as evaluated by two separate assessors who are blinded to treatment

      Interim Analysis The sample size for this Phase III Trial is projected to be 690 subjects.
      For interim analyses, the method of Lan and DeMets will be used to allocate alpha via the
      power family method with φ (phi) equal to 1 for the assessment of efficacy and futility,
      respectively after the first 174, 346 and 518 patients enrolled have completed the 90-day
      follow-up. The interval may be more frequent if requested by the Data and Safety Monitoring
      Board (DSMB). At interim analysis, in case the stopping boundaries are crossed the DSMB may
      recommend stopping the study either for better efficacy of the tested treatment either for
      futility. Other factors, such as safety, will be taken into consideration by the DSMB in the
      decision to stop the study. When considering stopping the trial for safety reasons, the DSMB
      will be instructed to consider both mortality (mRS=6) and severe dependency (mRS=5) at 3
      months as one single outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Distribution of the modified Rankin Scale scores (shift analysis)
time frame: 90 days
description: Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors who are blinded to treatment
measure: Functional independence (modified Rankin Score ≤ 2)
time frame: 90 days
description: Functional independence measured by modified Rankin Score ≤ 2 in 90 days in both groups
measure: Infarct Burden at 24 hours
time frame: 24 hours
description: ASPECTS change from baseline to 24 hours on CT or MRI
measure: Dramatic early favorable response
time frame: 24 hours
description: defined as an NIHSS score 0-2 or a NIHSS score decrease of ≥8 from baseline at 24 hours
measure: Cost effectiveness
time frame: Life-time horizon perspective
description: Cost effectiveness analysis of interventional therapy vs medical therapy alone
measure: Quality of life analysis
time frame: 3 months, 6 months, 1 year
description: Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and one year, between interventional therapy vs medical therapy alone
measure: Vessel recanalization at 24 hours
time frame: 24 hours
description: Vessel recanalization evaluated by CT angiography (CTA) or MR angiography (MRA) at 24 hours in both treatment groups
measure: Successful recanalization at the end of procedure
time frame: immediatelly after procedure (only thrombectomy arm)
description: defined as a grade of 2b or 3 (indicating reperfusion of >50% of the affected territory) on the modified Thrombolysis in Cerebral Infarction (mTICI) scale
measure: Mortality
time frame: 90 days
description: Mortality at 90 days
measure: Symptomatic Intracranial hemorrhage
time frame: 24 hours
description: Clinically significant Intracranial hemorrhage (ICH) rates at 24 (-2/+12) hours. All intracerebral hemorrhages will be classified by a central core-lab using the ECASS criteria for CT evaluation. Symptomatic ICH will be defined as per the SITS-MOST definition: deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans. The incidence of any asymptomatic hemorrhage measured at 24 (-2/+12) hours will also be compared
measure: Procedure related complications
time frame: During the procedure
description: Complications occurring during the procedure will be evaluated: distal embolization in a new territory, arterial dissection, arterial perfuration, groin hematoma
arm group label: thrombectomy
arm group type: Experimental
description: mechanical thrombectomy with stentriever Solitaire FR® and/or thromboaspiration with Penumbra System® in patients with large vessel occlusion in cerebral anterior circulation vessels
arm group label: best medical treatment
arm group type: No Intervention
description: best medical treatment in patients with acute ischemic stroke with anterior circulation large vessel occlusion
intervention type: Procedure
intervention name: Thrombectomy
description: Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever Solitaire FR® and/or thromboaspiration with Penumbra System® versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting.
arm group label: thrombectomy
other name: Endovascular treatment
other name: Intrarterial treatment
other name: Endovascular revascularization
intervention type: Device
intervention name: Stentriever Solitaire FR® or Penumbra System®
description: Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting.
arm group label: thrombectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raul Nogueira, MD
role: Principal Investigator
affiliation: Emory University
last name: Sheila CO Martins, MD
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
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country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital de Clinicas de Porto Alegre
investigator full name: SHEILA CRISTINA OURIQUES MARTINS
investigator title: MD, PHD, Stroke Neurologist
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
sharing ipd: No