<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/NCT02190552</url>
  </required_header>
  <id_info>
    <org_study_id>CIP001</org_study_id>
    <nct_id>NCT02190552</nct_id>
  </id_info>
  <brief_title>Analysis of Revascularisation in Ischemic Stroke With EmboTrap</brief_title>
  <acronym>ARISE</acronym>
  <official_title>A.R.I.S.E. Analysis of Revascularisation in Ischemic Stroke With EmboTrap: Post Marketing Observational Study of CE Marked EmboTrap Mechanical Thrombectomy Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neuravi Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neuravi Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A.R.I.S.E. is a post approval observational study using standard care. The purpose of this&#xD;
      study is to collect information about the ability of the EmboTrap device to remove blood&#xD;
      clots from the brain, and the associated performance characteristics and clinical outcomes.&#xD;
      No formal hypothesis testing is needed as no comparisons are planned within the study.&#xD;
      Instead, estimates of each population parameter of interest for all primary and secondary&#xD;
      endpoints will be provided using appropriate confidence intervals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Proportion of Revascularisation Following the Use of the Neuravi Device.</measure>
    <time_frame>Day 1</time_frame>
    <description>Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater.&#xD;
mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:&#xD;
mTICI 0 = No perfusion&#xD;
mTICI 1 = Penetration but not perfusion&#xD;
mTICI 2a = Some perfusion with distal branch filling of &lt;50% of territory visualized&#xD;
mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized&#xD;
mTICI 2c = Near-complete perfusion&#xD;
mTICI 3 = Complete perfusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Revascularization</measure>
    <time_frame>Day 1</time_frame>
    <description>Defined as time from groin puncture to visualization of final angiographic result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality Post Procedure</measure>
    <time_frame>7 and 90(±14) days post procedure</time_frame>
    <description>All procedure related mortality (i.e. directly traceable to a procedure related SAE).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Device Related Effects (SADE)</measure>
    <time_frame>24(-8/+12) hours Post Procedure</time_frame>
    <description>SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic ICH</measure>
    <time_frame>24(-8/+12) hours Post Procedure</time_frame>
    <description>Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale.&#xD;
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Outcome at 90 Days</measure>
    <time_frame>90(±14) days Post Procedure</time_frame>
    <description>A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days.&#xD;
mRS is a scale 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. mRS scores range from 0 to 6:&#xD;
mRS 0 = No symptoms.&#xD;
mRS 1 = No significant disability.&#xD;
mRS 2 = Slight disability.&#xD;
mRS 3 = Moderate disability.&#xD;
mRS 4 = Moderately severe disability.&#xD;
mRS 5 = Severe disability.&#xD;
mRS 6 = Dead.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of New Territory Embolization</measure>
    <time_frame>24(-8/+12) hours Post Procedure</time_frame>
    <description>Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence of Infarction</measure>
    <time_frame>24(-8/+12) hours Post Procedure</time_frame>
    <description>Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>EmboTrap® Revascularization Device</arm_group_label>
    <description>The EmboTrap® Revascularization Device is the investigational device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EmboTrap® Revascularization Device</intervention_name>
    <arm_group_label>EmboTrap® Revascularization Device</arm_group_label>
    <other_name>EmboTrap</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Ischemic stroke patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient or the patient's legally authorized representative has signed and dated an&#xD;
             Informed Consent Form.&#xD;
&#xD;
          -  Aged between 18 years and 80 years (inclusive).&#xD;
&#xD;
          -  A new focal disabling neurologic deficit consistent with acute cerebral ischemia.&#xD;
&#xD;
          -  NIHSS score ≥8 and ≤25.&#xD;
&#xD;
          -  Pre-ictal mRS score of 0 or 1.&#xD;
&#xD;
          -  Angiographic confirmation of an occlusion of an ICA (including T and L occlusions), M1&#xD;
             or M2, MCA, or BA with TICI flow of 0-1.&#xD;
&#xD;
          -  Confirmation by the interventionalist, after screening CT or MRI, that the treatment&#xD;
             site can be accessed with the Neuravi device.&#xD;
&#xD;
          -  The interventionalist estimates that at least one deployment of the Neuravi device can&#xD;
             be completed within 5 hours from the onset of symptoms, or if time of onset of&#xD;
             symptoms is unknown or &gt; 5 hours, patients can be included using imaging with the&#xD;
             following criteria:&#xD;
&#xD;
               1. MRI criterion: ASPECTS 8 to 10, or,volume of diffusion restriction ≤30 mL and&#xD;
                  mismatch between perfusion reduction and diffusion restriction present.&#xD;
&#xD;
               2. CT criterion: ASPECTS 8 to 10 on baseline CT or CTA-source images, or, volume of&#xD;
                  significantly lowered CBV ≤30 mL and mismatch between perfusion reduction and low&#xD;
                  CBV present.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy of less than 6 months.&#xD;
&#xD;
          -  Females who are pregnant or lactating.&#xD;
&#xD;
          -  History of severe allergy to contrast medium.&#xD;
&#xD;
          -  Has suffered a stroke in the past three months.&#xD;
&#xD;
          -  The patient presents with an NIHSS score &lt;8 or &gt;25 or is physician assessed as being&#xD;
             in a clinically relevant uninterrupted coma.&#xD;
&#xD;
          -  Use of warfarin anticoagulation with International Normalized Ratio (INR) &gt; 3.0.&#xD;
&#xD;
          -  Platelet count &lt; 50,000.&#xD;
&#xD;
          -  Glucose &lt; 50 mg/dL.&#xD;
&#xD;
          -  Heparin use in previous 24 hours with PTT or ACT &gt; 2X normal.&#xD;
&#xD;
          -  Any known hemorrhagic or coagulation deficiency.&#xD;
&#xD;
          -  Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh&#xD;
             hemorrhage on presentation.&#xD;
&#xD;
          -  For basilar artery occlusion, extended early ischemic changes as confirmed by&#xD;
             pc-ASPECTS ≤ 7 on baseline CT or CTA-source images, or extensive DWI lesions in the&#xD;
             midbrain or pons regions on pre-treatment MRI.&#xD;
&#xD;
          -  Baseline CT or MRI showing mass effect or intracranial tumor (except small&#xD;
             meningioma).&#xD;
&#xD;
          -  Excessive arterial tortuosity that precludes the study device from reaching the target&#xD;
             vessel.&#xD;
&#xD;
          -  A proximal stenosis or complete occlusion that cannot, as judged by the responsible&#xD;
             interventionalist, be treated safely or which prevents access to the occluded vessel&#xD;
             with the Neuravi device.&#xD;
&#xD;
          -  Evidence of active infection.&#xD;
&#xD;
          -  Known cancer with metastases&#xD;
&#xD;
          -  Current use of cocaine or other vasoactive substance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Tommy Andersson</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Prof. Dr. Heinrich Mattle</last_name>
    <role>Principal Investigator</role>
    <affiliation>Insel Gruppe AG, University Hospital Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Kiel</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Institutet</name>
      <address>
        <city>Solna</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Spain</country>
    <country>Sweden</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Switzerland</country>
  </removed_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>April 17, 2018</results_first_submitted>
  <results_first_submitted_qc>November 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 11, 2019</results_first_posted>
  <last_update_submitted>November 16, 2018</last_update_submitted>
  <last_update_submitted_qc>November 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain</keyword>
  <keyword>Brain Clot</keyword>
  <keyword>Brain Diseases</keyword>
  <keyword>Brain Infarction</keyword>
  <keyword>Cerebral Ischemia</keyword>
  <keyword>Cerebrovascular Disorders</keyword>
  <keyword>EmboTrap® Revascularization Device</keyword>
  <keyword>EmboTrap</keyword>
  <keyword>Ischemia</keyword>
  <keyword>Ischemic</keyword>
  <keyword>Ischemic Stroke</keyword>
  <keyword>Mechanical Thrombectomy</keyword>
  <keyword>Neurovascular Intervention</keyword>
  <keyword>Revascularization</keyword>
  <keyword>Stent Retriever</keyword>
  <keyword>Stroke</keyword>
  <keyword>Vascular Diseases</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>EmboTrap® Revascularization Device</title>
          <description>The EmboTrap® Revascularization Device is the investigational device&#xD;
EmboTrap® Revascularization Device</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>EmboTrap® Revascularization Device</title>
          <description>The EmboTrap® Revascularization Device is the investigational device&#xD;
EmboTrap® Revascularization Device</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </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="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" spread="14"/>
                  </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="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Sweden</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ireland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>National Institutes of Health Stroke Scale (NIHSS) Score</title>
          <description>The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.</description>
          <units>units on a scale</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="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</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="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Revascularisation Following the Use of the Neuravi Device.</title>
        <description>Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater.&#xD;
mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:&#xD;
mTICI 0 = No perfusion&#xD;
mTICI 1 = Penetration but not perfusion&#xD;
mTICI 2a = Some perfusion with distal branch filling of &lt;50% of territory visualized&#xD;
mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized&#xD;
mTICI 2c = Near-complete perfusion&#xD;
mTICI 3 = Complete perfusion</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EmboTrap® Revascularization Device</title>
            <description>The EmboTrap® Revascularization Device is the investigational device</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Revascularisation Following the Use of the Neuravi Device.</title>
          <description>Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater.&#xD;
mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:&#xD;
mTICI 0 = No perfusion&#xD;
mTICI 1 = Penetration but not perfusion&#xD;
mTICI 2a = Some perfusion with distal branch filling of &lt;50% of territory visualized&#xD;
mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized&#xD;
mTICI 2c = Near-complete perfusion&#xD;
mTICI 3 = Complete perfusion</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Revascularization</title>
        <description>Defined as time from groin puncture to visualization of final angiographic result.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EmboTrap® Revascularization Device</title>
            <description>The EmboTrap® Revascularization Device is the investigational device&#xD;
EmboTrap® Revascularization Device</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Revascularization</title>
          <description>Defined as time from groin puncture to visualization of final angiographic result.</description>
          <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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" spread="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality Post Procedure</title>
        <description>All procedure related mortality (i.e. directly traceable to a procedure related SAE).</description>
        <time_frame>7 and 90(±14) days post procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EmboTrap® Revascularization Device</title>
            <description>The EmboTrap® Revascularization Device is the investigational device&#xD;
EmboTrap® Revascularization Device</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality Post Procedure</title>
          <description>All procedure related mortality (i.e. directly traceable to a procedure related SAE).</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="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Procedure-related Mortality at Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All cause Mortality at Day 90</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serious Adverse Device Related Effects (SADE)</title>
        <description>SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.</description>
        <time_frame>24(-8/+12) hours Post Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EmboTrap® Revascularization Device</title>
            <description>The EmboTrap® Revascularization Device is the investigational device&#xD;
EmboTrap® Revascularization Device</description>
          </group>
        </group_list>
        <measure>
          <title>Serious Adverse Device Related Effects (SADE)</title>
          <description>SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.</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="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptomatic ICH</title>
        <description>Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale.&#xD;
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.</description>
        <time_frame>24(-8/+12) hours Post Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>EmboTrap® Revascularization Device</title>
            <description>The EmboTrap® Revascularization Device is the investigational device&#xD;
EmboTrap® Revascularization Device</description>
          </group>
        </group_list>
        <measure>
          <title>Symptomatic ICH</title>
          <description>Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale.&#xD;
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.</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="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Outcome at 90 Days</title>
        <description>A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days.&#xD;
mRS is a scale 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. mRS scores range from 0 to 6:&#xD;
mRS 0 = No symptoms.&#xD;
mRS 1 = No significant disability.&#xD;
mRS 2 = Slight disability.&#xD;
mRS 3 = Moderate disability.&#xD;
mRS 4 = Moderately severe disability.&#xD;
mRS 5 = Severe disability.&#xD;
mRS 6 = Dead.</description>
        <time_frame>90(±14) days Post Procedure</time_frame>
        <population>Data was not collected for all participants.</population>
        <group_list>
          <group group_id="O1">
            <title>EmboTrap® Revascularization Device</title>
            <description>The EmboTrap® Revascularization Device is the investigational device&#xD;
EmboTrap® Revascularization Device</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Outcome at 90 Days</title>
          <description>A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days.&#xD;
mRS is a scale 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. mRS scores range from 0 to 6:&#xD;
mRS 0 = No symptoms.&#xD;
mRS 1 = No significant disability.&#xD;
mRS 2 = Slight disability.&#xD;
mRS 3 = Moderate disability.&#xD;
mRS 4 = Moderately severe disability.&#xD;
mRS 5 = Severe disability.&#xD;
mRS 6 = Dead.</description>
          <population>Data was not collected for all participants.</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="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of New Territory Embolization</title>
        <description>Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.</description>
        <time_frame>24(-8/+12) hours Post Procedure</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>EmboTrap® Revascularization Device</title>
            <description>The EmboTrap® Revascularization Device is the investigational device</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of New Territory Embolization</title>
          <description>Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evidence of Infarction</title>
        <description>Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.</description>
        <time_frame>24(-8/+12) hours Post Procedure</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>EmboTrap® Revascularization Device</title>
            <description>The EmboTrap® Revascularization Device is the investigational device</description>
          </group>
        </group_list>
        <measure>
          <title>Evidence of Infarction</title>
          <description>Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>EmboTrap® Revascularization Device</title>
          <description>The EmboTrap® Revascularization Device is the investigational device&#xD;
EmboTrap® Revascularization Device</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke in evolution</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Neurological Deterioration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Vessel perforation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</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="24" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Other Cardiac disorders</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Haemorrhagic transformation stroke</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Other Respiratory disorders</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mairsil Claffey</name_or_title>
      <organization>Neuravi Limited</organization>
      <phone>0035391394123</phone>
      <email>mclaffey@neuravi.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/NCT02190552
org study id: CIP001
nct id: NCT02190552
lead sponsor: 
has dmc: Yes
A.R.I.S.E. is a post approval observational study using standard care. The purpose of this
      study is to collect information about the ability of the EmboTrap device to remove blood
      clots from the brain, and the associated performance characteristics and clinical outcomes.
      No formal hypothesis testing is needed as no comparisons are planned within the study.
      Instead, estimates of each population parameter of interest for all primary and secondary
      endpoints will be provided using appropriate confidence intervals.
observational model: Cohort
time perspective: Prospective
measure: Proportion of Revascularisation Following the Use of the Neuravi Device.
time frame: Day 1
description: Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater.
mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:
mTICI 0 = No perfusion
mTICI 1 = Penetration but not perfusion
mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized
mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized
mTICI 2c = Near-complete perfusion
mTICI 3 = Complete perfusion
measure: Time to Revascularization
time frame: Day 1
description: Defined as time from groin puncture to visualization of final angiographic result.
measure: Mortality Post Procedure
time frame: 7 and 90(±14) days post procedure
description: All procedure related mortality (i.e. directly traceable to a procedure related SAE).
measure: Serious Adverse Device Related Effects (SADE)
time frame: 24(-8/+12) hours Post Procedure
description: SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.
measure: Symptomatic ICH
time frame: 24(-8/+12) hours Post Procedure
description: Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale.
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.
measure: Clinical Outcome at 90 Days
time frame: 90(±14) days Post Procedure
description: A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days.
mRS is a scale 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. mRS scores range from 0 to 6:
mRS 0 = No symptoms.
mRS 1 = No significant disability.
mRS 2 = Slight disability.
mRS 3 = Moderate disability.
mRS 4 = Moderately severe disability.
mRS 5 = Severe disability.
mRS 6 = Dead.
measure: Rate of New Territory Embolization
time frame: 24(-8/+12) hours Post Procedure
description: Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.
measure: Evidence of Infarction
time frame: 24(-8/+12) hours Post Procedure
description: Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.
arm group label: EmboTrap® Revascularization Device
description: The EmboTrap® Revascularization Device is the investigational device
intervention type: Device
intervention name: EmboTrap® Revascularization Device
arm group label: EmboTrap® Revascularization Device
other name: EmboTrap
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dr. Tommy Andersson
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Prof. Dr. Heinrich Mattle
role: Principal Investigator
affiliation: Insel Gruppe AG, University Hospital Bern
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Germany
country: Ireland
country: Spain
country: Sweden
country: France
country: Switzerland
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 