<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/NCT03805308</url>
  </required_header>
  <id_info>
    <org_study_id>2018-49</org_study_id>
    <nct_id>NCT03805308</nct_id>
  </id_info>
  <brief_title>The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke</brief_title>
  <acronym>TESLA</acronym>
  <official_title>The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mercy Health Ohio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mercy Health Ohio</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>
      The primary objective of the trial is to establish the effectiveness of IAT (versus medical&#xD;
      management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with&#xD;
      adaptive enrichment to better define the upper limit of infarct volume for treatment&#xD;
      eligibility. Furthermore, the investigators aim to determine whether certain subgroups of&#xD;
      patients with large baseline infarcts will have a greater treatment benefit. Finally, the&#xD;
      investigators will assess the agreement of ASPECTS scores between site investigators, the&#xD;
      core imaging lab, and automated software.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, randomized, open-label, blinded endpoint study. Patients presenting with&#xD;
      symptoms of AIS who have evidence of a moderate-large infarct volume (Non-contrast CT Alberta&#xD;
      Stroke Program Early CT score [NCCT ASPECTS] 2-5 in the anterior circulation will be assigned&#xD;
      to either best medical management alone (including IV rtPA) or intra-arterial treatment (IAT)&#xD;
      with mechanical thrombectomy added to best medical management. Each treated patient will be&#xD;
      followed and assessed for 3 months after randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 16, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 16, 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>
    <intervention_model_description>TESLA is a pragmatic, phase III, prospective, randomized, open-label, blinded endpoint, multicenter trial. Patients with moderate-large infarcts will be assigned to either best medical management alone (including intravenous recombinant tissue-type plasminogen activator (IV rtPA)) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the instructions for use (IFU). Patients will be enrolled at up to 25 centers over an anticipated three-year period, with an additional year for trial closeout.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The patient and the treating physician will be aware of the treatment assignment. Assessment of outcome on NIHSS and mRS will be performed by a certified rater blinded to the treatment allocation. Each site must designate one or more individual(s) to perform these blinded assessments at 24 (16-36) hours, 6 ± 1 days or discharge (whichever is earlier), 30 days ± 7 days, and 90 days ± 30 days from randomization.&#xD;
Neuroimaging core lab evaluation will also be assessed in a blinded manner, except for angiographic revascularization grading which will only be performed for the intra-arterial treatment arm.&#xD;
Information on treatment allocation will be stored separately from the main study database. An unblinded independent statistician will combine treatment allocation data with the clinical data in order to report to the DSMB. A second blinded statistician will be part of the steering committee.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Utility-weighted 90-day Modified Rankin Score</measure>
    <time_frame>90 days post randomization</time_frame>
    <description>Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death.&#xD;
0 = No symptoms at all.&#xD;
= No significant disability despite symptoms; able to carry out all usual duties and activities.&#xD;
= Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance.&#xD;
= Moderate disability requiring some help, but able to walk without assistance.&#xD;
= Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.&#xD;
= Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.&#xD;
= Death</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Medical Management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intra-arterial Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For patients randomized to the intra-arterial therapy arm, sites will use local protocols for femoral access, sedation, heparin infusion, monitoring, etc. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the IFU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intra-arterial Therapy</intervention_name>
    <description>Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.</description>
    <arm_group_label>Intra-arterial Therapy</arm_group_label>
    <other_name>Thrombectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 to 85 years of age&#xD;
&#xD;
          2. Presenting with symptoms consistent with an acute ischemic stroke&#xD;
&#xD;
          3. Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery&#xD;
             (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment&#xD;
&#xD;
          4. NIHSS score &gt;6 at the time of randomization&#xD;
&#xD;
          5. Ability to randomize within 24 hours of stroke onset&#xD;
&#xD;
          6. Pre-stroke mRS score 0-1&#xD;
&#xD;
          7. Ability to obtain signed informed consent&#xD;
&#xD;
        Imaging evidence of moderate-large infarct defined as:&#xD;
&#xD;
        1. NCCT ASPECTS 2-5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant, or those of child-bearing potential with positive urine or&#xD;
             serum beta Human Chorionic Gonadotropin (HCG) test&#xD;
&#xD;
          2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications&#xD;
&#xD;
          3. Refractory hypertension (defined as persistent systolic blood pressure &gt;185 mmHg or&#xD;
             diastolic blood pressure &gt;110 mmHg)&#xD;
&#xD;
          4. CT evidence of the following conditions:&#xD;
&#xD;
               -  Midline shift or herniation&#xD;
&#xD;
               -  Evidence of intracranial hemorrhage&#xD;
&#xD;
               -  Mass effect with effacement of the ventricles&#xD;
&#xD;
          5. Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular&#xD;
             access per the treating interventionalist&#xD;
&#xD;
          6. Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or&#xD;
             dissection)&#xD;
&#xD;
          7. Rapidly improving neurological status prior to randomization to NIHSS &lt;6&#xD;
&#xD;
          8. Bilateral strokes or multiple intracranial occlusions&#xD;
&#xD;
          9. Intracranial tumors&#xD;
&#xD;
         10. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant&#xD;
             therapy with an International Normalized Ratio (INR) of &gt;3.0 or Partial Thromboplastin&#xD;
             Time (PTT) &gt;3 times of normal&#xD;
&#xD;
         11. Baseline platelet count &lt;30,000 per microliter (µl)&#xD;
&#xD;
         12. Life expectancy less than 90 days prior to stroke onset&#xD;
&#xD;
         13. Participation in another randomized clinical trial that could confound the evaluation&#xD;
             of the study&#xD;
&#xD;
         14. Any other condition (in the opinion of the site investigator) that precludes an&#xD;
             endovascular procedure or poses a significant hazard to the patient if an endovascular&#xD;
             procedure was performed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Albert J Yoo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Stroke Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Osama O Zaidat, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mercy Health St. Vincent Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baptist Health Center for Clinical Research</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pomona Valley Hospital Medical Center</name>
      <address>
        <city>Pomona</city>
        <state>California</state>
        <zip>91767</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Institute for Medical Research</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center &amp; Mills Peninsula Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Robles Hospital and Medical Center</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Saint John's Health Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boca Raton Regional Hospital Inc.</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health Inc.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellstar Health System, Inc.</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center</name>
      <address>
        <city>Lisle</city>
        <state>Illinois</state>
        <zip>60532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital</name>
      <address>
        <city>Winfield</city>
        <state>Illinois</state>
        <zip>60190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lutheran Medical Group</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Munster Medical Research Foundation</name>
      <address>
        <city>Munster</city>
        <state>Indiana</state>
        <zip>46321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Healthcare System Inc. d/b/a Baptist Health Lexington</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSU Health Sciences Center at Shreveport</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Health Care Corporation</name>
      <address>
        <city>Grand Blanc</city>
        <state>Michigan</state>
        <zip>48439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sparrow Clinical Research Institute</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SSM Health DePaul Hospital</name>
      <address>
        <city>Bridgeton</city>
        <state>Missouri</state>
        <zip>63044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Community Hospital Group Inc. t/a JFK Medical Center</name>
      <address>
        <city>Edison</city>
        <state>New Jersey</state>
        <zip>08820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers The State University</name>
      <address>
        <city>Piscataway</city>
        <state>New Jersey</state>
        <zip>08854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Feinstein Institute for Medical Research, Northwell</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProMedica Toledo Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health St. Vincent Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Tech University of Health Sciences</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Stroke Institute</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Medical Center</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Research Institute</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mercy Health Ohio</investigator_affiliation>
    <investigator_full_name>Dr. Osama O. Zaidat</investigator_full_name>
    <investigator_title>Neuroscience and Stroke Medical Director</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Ischemic Stroke</keyword>
  <keyword>Thrombectomy</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>
    <ipd_description>All shared data will be aggregate.</ipd_description>
  </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/NCT03805308
org study id: 2018-49
nct id: NCT03805308
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of the trial is to establish the effectiveness of IAT (versus medical
      management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with
      adaptive enrichment to better define the upper limit of infarct volume for treatment
      eligibility. Furthermore, the investigators aim to determine whether certain subgroups of
      patients with large baseline infarcts will have a greater treatment benefit. Finally, the
      investigators will assess the agreement of ASPECTS scores between site investigators, the
      core imaging lab, and automated software.
Prospective, randomized, open-label, blinded endpoint study. Patients presenting with
      symptoms of AIS who have evidence of a moderate-large infarct volume (Non-contrast CT Alberta
      Stroke Program Early CT score [NCCT ASPECTS] 2-5 in the anterior circulation will be assigned
      to either best medical management alone (including IV rtPA) or intra-arterial treatment (IAT)
      with mechanical thrombectomy added to best medical management. Each treated patient will be
      followed and assessed for 3 months after randomization.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: TESLA is a pragmatic, phase III, prospective, randomized, open-label, blinded endpoint, multicenter trial. Patients with moderate-large infarcts will be assigned to either best medical management alone (including intravenous recombinant tissue-type plasminogen activator (IV rtPA)) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the instructions for use (IFU). Patients will be enrolled at up to 25 centers over an anticipated three-year period, with an additional year for trial closeout.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The patient and the treating physician will be aware of the treatment assignment. Assessment of outcome on NIHSS and mRS will be performed by a certified rater blinded to the treatment allocation. Each site must designate one or more individual(s) to perform these blinded assessments at 24 (16-36) hours, 6 ± 1 days or discharge (whichever is earlier), 30 days ± 7 days, and 90 days ± 30 days from randomization.
Neuroimaging core lab evaluation will also be assessed in a blinded manner, except for angiographic revascularization grading which will only be performed for the intra-arterial treatment arm.
Information on treatment allocation will be stored separately from the main study database. An unblinded independent statistician will combine treatment allocation data with the clinical data in order to report to the DSMB. A second blinded statistician will be part of the steering committee.
measure: Utility-weighted 90-day Modified Rankin Score
time frame: 90 days post randomization
description: Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death.
0 = No symptoms at all.
= No significant disability despite symptoms; able to carry out all usual duties and activities.
= Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance.
= Moderate disability requiring some help, but able to walk without assistance.
= Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
= Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.
= Death
arm group label: Medical Management
arm group type: No Intervention
description: Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.
arm group label: Intra-arterial Therapy
arm group type: Experimental
description: For patients randomized to the intra-arterial therapy arm, sites will use local protocols for femoral access, sedation, heparin infusion, monitoring, etc. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the IFU.
intervention type: Procedure
intervention name: Intra-arterial Therapy
description: Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.
arm group label: Intra-arterial Therapy
other name: Thrombectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Albert J Yoo, MD, PhD
role: Principal Investigator
affiliation: Texas Stroke Institute
last name: Osama O Zaidat, MD, MS
role: Principal Investigator
affiliation: Mercy Health St. Vincent Medical Center
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country: United States
responsible party type: Principal Investigator
investigator affiliation: Mercy Health Ohio
investigator full name: Dr. Osama O. Zaidat
investigator title: Neuroscience and Stroke Medical Director
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
sharing ipd: No
ipd description: All shared data will be aggregate.