<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/NCT02239640</url>
  </required_header>
  <id_info>
    <org_study_id>NV-SFR005</org_study_id>
    <nct_id>NCT02239640</nct_id>
  </id_info>
  <brief_title>Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry</brief_title>
  <official_title>Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Neurovascular Clinical Affairs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Neurovascular Clinical Affairs</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this registry is to assess clinical outcomes, and different factors that may&#xD;
      affect these clinical outcomes such as systems of care, associated with the use of Covidien&#xD;
      market-released neurothrombectomy devices intended to restore blood flow in patients&#xD;
      experiencing acute ischemic stroke due to large intracranial vessel occlusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, non-randomized, observational registry of acute ischemic&#xD;
      stroke patients that have or will undergo treatment with the use of a Covidien&#xD;
      market-released neurothrombectomy device (as the initial device used to remove the thrombus)&#xD;
      within 8 hours of stroke symptom onset, at the discretion of the investigator and independent&#xD;
      of participation in this registry. This registry may enroll up to 1000 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2014</start_date>
  <completion_date type="Actual">October 7, 2016</completion_date>
  <primary_completion_date type="Actual">October 7, 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>90 Days</target_duration>
  <primary_outcome>
    <measure>Number of Participants Assessed for Revascularization With mTICI Grades 2b-3</measure>
    <time_frame>Day 0-At the completion of the thrombectomy procedure</time_frame>
    <description>Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches.&#xD;
Classification:&#xD;
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Neurological Events of Interest</measure>
    <time_frame>up to 90 days post index procedure</time_frame>
    <description>Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>All-cause Mortality</measure>
    <time_frame>up to 90 days post index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Good Functional Outcome (mRS 0-2)</measure>
    <time_frame>90 days post index procedure</time_frame>
    <description>Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke.&#xD;
Clasiffication:&#xD;
0 - No symptoms.&#xD;
- No significant disability. Able to carry out all usual activities, despite some symptoms.&#xD;
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.&#xD;
- Moderate disability. Requires some help, but able to walk unassisted.&#xD;
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.&#xD;
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.&#xD;
- Dead. (lower values represent less disability)</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of Device Related Serious Adverse Events</measure>
    <time_frame>up to 90 days post index procedure</time_frame>
    <description>Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to Revascularization</measure>
    <time_frame>Day 0-At the completion of the thrombectomy procedure</time_frame>
    <description>Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of Procedure Related Serious Adverse Events</measure>
    <time_frame>up to 90 days post index procedure</time_frame>
    <description>Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">984</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Medtronic NV market-released device</arm_group_label>
    <description>Patients experiencing an acute ischemic stroke due to a large vessel occlusion treated with a Medtronic Neurovascular market-released neurothrombectomy device.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Acute Ischemic Stroke Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient or patient's legally authorized representative has given Informed Consent&#xD;
             according to Good Clinical Practices (GCP) and/or IRB and/or local or institutional&#xD;
             policies.&#xD;
&#xD;
          -  Patient has experienced an acute ischemic stroke due to large intracranial vessel&#xD;
             occlusion (with associated symptoms) and has been or will be treated with a Covidien&#xD;
             market-released neurothrombectomy device, as the initial device used to remove the&#xD;
             thrombus.&#xD;
&#xD;
          -  Treatment within 8 hours of stroke onset.&#xD;
&#xD;
          -  Pre-Stroke Modified Rankin Scale (mRS) score ≤ 1 (immediately) prior to stroke onset.&#xD;
&#xD;
          -  Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent participation in a multicenter randomized study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nils Mueller-Kronast, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Advanced Neuroscience Network/Tenet South Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner University Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arizona Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy San Juan Medical Center/ Mercy General</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</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Robles Medical Center</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Neuroscience Network/Tenet South Florida</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Broward Hospital</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Medical Center - Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Hospital of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WellStar Kennestone Regional Medical Center</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presence St. Joseph Medical Center</name>
      <address>
        <city>Joliet</city>
        <state>Illinois</state>
        <zip>60435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health Lexington/Central Baptist</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Hospital</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Hospital Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Healthcare</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John Providence Hospital, Detroit</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Flint</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic, Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Dominic's - Jackson Memorial Hospital</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital of Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnes Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buffalo General Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crouse Hospital</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OhioHealth Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</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>Providence St. Vincent Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University Hospital</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Clinic</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erlanger Medical Center</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Baptist Medical Center</name>
      <address>
        <city>Harlingen</city>
        <state>Texas</state>
        <zip>78550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Texas Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital, Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University/ Ruby Memorial</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Hospital, Milwaukee</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert Hospital</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>November 10, 2017</results_first_submitted>
  <results_first_submitted_qc>March 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 7, 2019</results_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only multi center data will be available</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Non-Randomized</title>
          <description>Observation registry.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="984"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="767"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="217"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="142"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Overall Study</title>
          <description>Subjects enrolled</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="984"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="984"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.8" spread="14.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="984"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="451"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Assessed for Revascularization With mTICI Grades 2b-3</title>
        <description>Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches.&#xD;
Classification:&#xD;
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes)</description>
        <time_frame>Day 0-At the completion of the thrombectomy procedure</time_frame>
        <population>824 participants contributed to this analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Successful Revascularization</title>
            <description>Successful reperfusion (mTICI 2b-3) per imaging core lab</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Assessed for Revascularization With mTICI Grades 2b-3</title>
          <description>Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches.&#xD;
Classification:&#xD;
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes)</description>
          <population>824 participants contributed to this analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="824"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="724"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Neurological Events of Interest</title>
        <description>Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)</description>
        <time_frame>up to 90 days post index procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Neurological Deterioration</title>
            <description>Neurological Deterioration up to 90 days (any event causing neurological deterioration; defined as ≥ 4 points worsening from baseline on the NIHSS scale).</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Neurological Events of Interest</title>
          <description>Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="984"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>All-cause Mortality</title>
        <time_frame>up to 90 days post index procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All-cause Mortality</title>
            <description>All cause mortality up to 90 days post index stroke procedure</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="984"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Good Functional Outcome (mRS 0-2)</title>
        <description>Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke.&#xD;
Clasiffication:&#xD;
0 - No symptoms.&#xD;
- No significant disability. Able to carry out all usual activities, despite some symptoms.&#xD;
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.&#xD;
- Moderate disability. Requires some help, but able to walk unassisted.&#xD;
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.&#xD;
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.&#xD;
- Dead. (lower values represent less disability)</description>
        <time_frame>90 days post index procedure</time_frame>
        <population>906 participants contributed to this analysis</population>
        <group_list>
          <group group_id="O1">
            <title>mRS at 90 Days</title>
            <description>mRS (0-2) at 90 Days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Good Functional Outcome (mRS 0-2)</title>
          <description>Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke.&#xD;
Clasiffication:&#xD;
0 - No symptoms.&#xD;
- No significant disability. Able to carry out all usual activities, despite some symptoms.&#xD;
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.&#xD;
- Moderate disability. Requires some help, but able to walk unassisted.&#xD;
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.&#xD;
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.&#xD;
- Dead. (lower values represent less disability)</description>
          <population>906 participants contributed to this analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="906"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence of Device Related Serious Adverse Events</title>
        <description>Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.</description>
        <time_frame>up to 90 days post index procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Device-related SAEs (Site Reported)</title>
            <description>Incidence of study device-related SAEs &lt;= 90 days post procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Device Related Serious Adverse Events</title>
          <description>Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="984"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time to Revascularization</title>
        <description>Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa.</description>
        <time_frame>Day 0-At the completion of the thrombectomy procedure</time_frame>
        <population>939 patients were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Time to Revascularization</title>
            <description>Puncture to TICI 2b-3 or completion</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Revascularization</title>
          <description>Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa.</description>
          <population>939 patients were analyzed</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="939"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.6" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence of Procedure Related Serious Adverse Events</title>
        <description>Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.</description>
        <time_frame>up to 90 days post index procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Procedure-related SAEs (Site Reported)</title>
            <description>Incidence of procedure-related SAEs &lt;= 90 days post procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Procedure Related Serious Adverse Events</title>
          <description>Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="984"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 90 days post index stroke procedure</time_frame>
      <desc>Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>Adverse Events</title>
          <description>Serious adverse events reported per protocol during the study</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="142" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="984"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cartotid Artery Dissection</sub_title>
                <description>Study device-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <description>Study device-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Carotid artery dissection</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Neurological decompensation</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Stroke in evolution</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Unresponsive to stimuli</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Femoral artery dissection</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Vasospasm</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
              <event>
                <sub_title>Vessel perforation</sub_title>
                <description>Index procedure-related SAE</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="984"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Researchers may Publish their individual site experience, but Sponsor reserves the exclusive right to Publish (or coordinate the Publication of) the complete accumulated results of the Registry, and to establish authorship criteria for such Publications for the Registry group based on Registry conduct and compliance, contribution to the Registry's design, management or enrollment and willingness to accept the rights and responsibilities of an author.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Oscar Bolanos</name_or_title>
      <organization>Medtronic</organization>
      <phone>949-527-0822</phone>
      <email>Oscar.bolanos@medtronic.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02239640
org study id: NV-SFR005
nct id: NCT02239640
lead sponsor: 
has dmc: No
The purpose of this registry is to assess clinical outcomes, and different factors that may
      affect these clinical outcomes such as systems of care, associated with the use of Covidien
      market-released neurothrombectomy devices intended to restore blood flow in patients
      experiencing acute ischemic stroke due to large intracranial vessel occlusion.
This is a prospective, multi-center, non-randomized, observational registry of acute ischemic
      stroke patients that have or will undergo treatment with the use of a Covidien
      market-released neurothrombectomy device (as the initial device used to remove the thrombus)
      within 8 hours of stroke symptom onset, at the discretion of the investigator and independent
      of participation in this registry. This registry may enroll up to 1000 patients.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants Assessed for Revascularization With mTICI Grades 2b-3
time frame: Day 0-At the completion of the thrombectomy procedure
description: Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches.
Classification:
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes)
measure: Incidence of Neurological Events of Interest
time frame: up to 90 days post index procedure
description: Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)
measure: All-cause Mortality
time frame: up to 90 days post index procedure
measure: Number of Participants With Good Functional Outcome (mRS 0-2)
time frame: 90 days post index procedure
description: Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke.
Clasiffication:
0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead. (lower values represent less disability)
measure: Incidence of Device Related Serious Adverse Events
time frame: up to 90 days post index procedure
description: Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.
measure: Time to Revascularization
time frame: Day 0-At the completion of the thrombectomy procedure
description: Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa.
measure: Incidence of Procedure Related Serious Adverse Events
time frame: up to 90 days post index procedure
description: Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.
arm group label: Medtronic NV market-released device
description: Patients experiencing an acute ischemic stroke due to a large vessel occlusion treated with a Medtronic Neurovascular market-released neurothrombectomy device.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nils Mueller-Kronast, M.D.
role: Principal Investigator
affiliation: Advanced Neuroscience Network/Tenet South Florida
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country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
sharing ipd: No
ipd description: Only multi center data will be available
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