<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/NCT01716117</url>
  </required_header>
  <id_info>
    <org_study_id>SP-04</org_study_id>
    <nct_id>NCT01716117</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms</brief_title>
  <acronym>SCENT</acronym>
  <official_title>The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stryker Neurovascular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stryker Neurovascular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical research study is designed to determine safety and effectiveness of the Surpass&#xD;
      Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large&#xD;
      or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood&#xD;
      vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left&#xD;
      untreated, the bulge may continue to grow larger and ultimately the vessel may break open&#xD;
      (rupture), resulting in serious bleeding into or around the brain. The information collected&#xD;
      from this study will be used to evaluate how well patients do when treated with the Surpass&#xD;
      System both immediately after treatment of an aneurysm and over a long period of time (5&#xD;
      years).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to determine safety and effectiveness of the Surpass Flow&#xD;
      Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked&#xD;
      intracranial aneurysms in the internal carotid artery up to the terminus. The Surpass Flow&#xD;
      Diverter is an intracranial implant designed to be placed in a parent artery so as to divert&#xD;
      blood flow away from an aneurysm. Use of the Surpass System may be associated with a decrease&#xD;
      in neurological death or ipsilateral stroke in patients with large or giant wide-neck&#xD;
      aneurysms. In a given patient, the Surpass System will be deemed effective if treatment&#xD;
      results in complete occlusion of their aneurysm without clinically significant stenosis of&#xD;
      the parent artery, or requires retreatment of the aneurysm through 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2012</start_date>
  <completion_date type="Actual">July 7, 2022</completion_date>
  <primary_completion_date type="Actual">December 11, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The SCENT Trial is a multi-center, prospective, non-randomized trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit.</measure>
    <time_frame>12 months</time_frame>
    <description>Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up.</measure>
    <time_frame>12 months</time_frame>
    <description>Subjects experiencing neurologic death or major ipsilateral stroke through 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure</measure>
    <time_frame>12 months</time_frame>
    <description>The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration (best); Class II: residual neck; Class III: residual aneurysm (worse).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up</measure>
    <time_frame>12 Months</time_frame>
    <description>Patients with minor strokes through 12 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus &lt; 65 Years in mITT Population</measure>
    <time_frame>12 Months</time_frame>
    <description>Primary effectiveness by age group</description>
  </other_outcome>
  <other_outcome>
    <measure>CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population</measure>
    <time_frame>12 Months</time_frame>
    <description>Primary effectiveness by intracranial aneurysm size</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations</measure>
    <time_frame>12 Months</time_frame>
    <description>Number of devices implanted in subjects by study population</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>Brain Aneurysm</condition>
  <arm_group>
    <arm_group_label>Surpass Flow Diverter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The objective of this study is to determine the safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surpass Flow Diverter</intervention_name>
    <description>Treatment of an intracranial aneurysm involves the placement of a specially designed metallic mesh tube in a vessel in the brain where an aneurysm is located. The device looks like a fishnet sock with both ends open. Each device is delivered through a small catheter (a long, flexible tube). The catheter containing the device is inserted and advanced into a vessel in the brain. The device is then placed in the brain vessel by releasing it from the catheter. Once the device is placed inside the brain vessel, it is intended to reinforce the area of the vessel that is weakened and bulging (the aneurysm), and to cause blood to flow down the vessel and away from the aneurysm while allowing blood in the aneurysm to clot. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels.</description>
    <arm_group_label>Surpass Flow Diverter</arm_group_label>
    <other_name>Flow diverter</other_name>
    <other_name>Endovascular aneurysm treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19 to 80 years&#xD;
&#xD;
          -  Subject or legal representative is willing and able to give informed consent&#xD;
&#xD;
          -  Subject has a single targeted intracranial aneurysm&#xD;
&#xD;
          -  Subject agrees to return to the treating Investigator for all scheduled follow up&#xD;
             visits and is capable of returning to the hospital for follow up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or&#xD;
             general anesthesia&#xD;
&#xD;
          -  Known history of life threatening allergy to contrast dye&#xD;
&#xD;
          -  Known allergy to nickel, chromium cobalt, tungsten or platinum&#xD;
&#xD;
          -  Subject has documented resistance to clopidogrel/Plavix&#xD;
&#xD;
          -  Major surgery within previous 30 days or planned in the next 120 days after enrollment&#xD;
             date&#xD;
&#xD;
          -  Previous intracranial implant associated with the symptomatic distribution within the&#xD;
             past 12 weeks prior to treatment date&#xD;
&#xD;
          -  Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral&#xD;
             artery) or intracranial artery within 30 days prior to treatment date&#xD;
&#xD;
          -  Any previous stenting of parent artery at or proximal to the aneurysm where it would&#xD;
             interfere with the placement and proper apposition of the device&#xD;
&#xD;
          -  Any previous coiling where it would interfere with the placement and proper apposition&#xD;
             of the device&#xD;
&#xD;
          -  Platelet count less than 100,000 cells/mm3 or known platelet dysfunction&#xD;
&#xD;
          -  More than one intracranial aneurysm (IA) that requires treatment within 12 months&#xD;
&#xD;
          -  Asymptomatic extradural aneurysms requiring treatment&#xD;
&#xD;
          -  Contraindication to CT scan or MRI&#xD;
&#xD;
          -  Severe neurological deficit that renders the subject incapable of living independently&#xD;
&#xD;
          -  Unstable neurological deficit (i.e., worsening of clinical condition in the last 30&#xD;
             days)&#xD;
&#xD;
          -  Evidence of active infection at the time of treatment&#xD;
&#xD;
          -  Dementia or psychiatric problem that prevents the patient from completing required&#xD;
             follow up&#xD;
&#xD;
          -  Co-morbid conditions that may limit survival to less than 24 months&#xD;
&#xD;
          -  Serum creatinine greater or equal to 2.5 mg/dL&#xD;
&#xD;
          -  Female subjects who are pregnant or planning to become pregnant within the study&#xD;
             period&#xD;
&#xD;
          -  Subject with anatomy not appropriate for endovascular treatment due to severe&#xD;
             intracranial vessel tortuosity or stenosis&#xD;
&#xD;
          -  Extra-cranial stenosis or parent vessel with stenosis greater than 50% in the area&#xD;
             proximal to the aneurysm&#xD;
&#xD;
          -  Other known serious concurrent medical conditions&#xD;
&#xD;
          -  History of intracranial vasospasm not responsive to medical therapy&#xD;
&#xD;
          -  Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma or&#xD;
             sarcoma of the head or neck region&#xD;
&#xD;
          -  Subject has a history of bleeding diathesis or coagulopathy, international normalized&#xD;
             ratio (INR) greater than 1.5, or will refuse blood transfusions&#xD;
&#xD;
          -  Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date&#xD;
&#xD;
          -  Subject has a non-treated arteriovenous malformation (AVM) in the territory of the&#xD;
             target aneurysm&#xD;
&#xD;
          -  Inability to understand the study or a history of non-compliance with medical advice&#xD;
&#xD;
          -  Current use of illicit substance&#xD;
&#xD;
          -  Enrollment in another trial involving an investigational product&#xD;
&#xD;
          -  Subject has a need for long-term use of anticoagulants (i.e., Warfarin, Dabigatran)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo A Hanel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lyerly Baptist Medical Center, Jacksonville, Florida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philip M Meyers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Barbara Cottage Hospital</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyerly Neurosurgery/Baptist Health System</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</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>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Minnesota</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University at Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</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>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Sanders Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas - Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC St Radboud</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>May 17, 2019</results_first_submitted>
  <results_first_submitted_qc>July 2, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 23, 2019</results_first_posted>
  <disposition_first_submitted>May 15, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>May 15, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 18, 2018</disposition_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Large aneurysm</keyword>
  <keyword>Giant aneurysm</keyword>
  <keyword>Wide neck aneurysm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium Carbonate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make IPD information available to other researchers. Blinded study data by mITT and Roll-in cohorts may be made available to SCENT researchers post publication of the primary study results.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Surpass Flow Diverter (mITT Population)</title>
          <description>The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.</description>
        </group>
        <group group_id="P2">
          <title>Surpass Flow Diverter (Roll-In Population)</title>
          <description>An additional 45 &quot;Roll-In&quot; subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 &quot;Roll-In&quot; and &quot;Enrolled but Not Treated&quot; subjects. Data from this population were not included in the mITT Primary Endpoint analysis. Neither did they serve as a control population. Results are displayed for informational purposes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="180"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Discharge</title>
              <participants_list>
                <participants group_id="P1" count="177"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>1-Month Visit</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6-Month Visit</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Surpass Flow Diverter (mITT)</title>
          <description>The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.</description>
        </group>
        <group group_id="B2">
          <title>Roll-In</title>
          <description>An additional 45 &quot;Roll-In&quot; subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 &quot;Roll-In&quot; and &quot;Enrolled but Not Treated&quot; subjects. Data from this population were not included in the mITT Primary Endpoint analysis. Neither did they serve as a control population. Results are displayed for informational purposes.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="180"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="213"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.0" spread="9.9"/>
                    <measurement group_id="B2" value="62.4" spread="11.1"/>
                    <measurement group_id="B3" value="61.2" spread="10.1"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Subjects may contribute toward more than one criterion for race. The total count may exceed the number of study subjects in each study cohort.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian/Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="158"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.5" lower_limit="38.0" upper_limit="80.0"/>
                    <measurement group_id="B2" value="65.0" lower_limit="39.0" upper_limit="79.0"/>
                    <measurement group_id="B3" value="62.0" lower_limit="38.0" upper_limit="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>inches (in)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.8" spread="3.2"/>
                    <measurement group_id="B2" value="64.3" spread="3.6"/>
                    <measurement group_id="B3" value="64.7" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>inches (in)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.0" lower_limit="52.0" upper_limit="75.0"/>
                    <measurement group_id="B2" value="64.2" lower_limit="59.1" upper_limit="72.0"/>
                    <measurement group_id="B3" value="65.0" lower_limit="52.0" upper_limit="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds (lbs)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="166.0" spread="40.2"/>
                    <measurement group_id="B2" value="154.5" spread="31.6"/>
                    <measurement group_id="B3" value="164.2" spread="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds (lbs)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="158.4" lower_limit="83.6" upper_limit="281.6"/>
                    <measurement group_id="B2" value="149.6" lower_limit="95.0" upper_limit="215.6"/>
                    <measurement group_id="B3" value="158.4" lower_limit="83.6" upper_limit="281.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>lbs/in^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.8" spread="6.1"/>
                    <measurement group_id="B2" value="26.3" spread="4.5"/>
                    <measurement group_id="B3" value="27.5" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>lbs/in^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.0" lower_limit="16.0" upper_limit="49.0"/>
                    <measurement group_id="B2" value="26.0" lower_limit="18.0" upper_limit="35.0"/>
                    <measurement group_id="B3" value="27.0" lower_limit="16.0" upper_limit="49.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status/Alcohol Use</title>
          <description>Subjects may contribute toward more than one criterion for smoking status.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Current Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Past Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current Consumer of Alcohol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit.</title>
        <description>Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.</description>
        <time_frame>12 months</time_frame>
        <population>The mITT primary endpoint analysis population (n = 180) is based on subjects in the mITT arm and does not include the results of subjects treated in the Roll-in population (n = 33).</population>
        <group_list>
          <group group_id="O1">
            <title>Surpass Flow Diverter (mITT Population)</title>
            <description>The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.</description>
          </group>
        </group_list>
        <measure>
          <title>mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit.</title>
          <description>Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.</description>
          <population>The mITT primary endpoint analysis population (n = 180) is based on subjects in the mITT arm and does not include the results of subjects treated in the Roll-in population (n = 33).</population>
          <units>Percent of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Primary Effectiveness Endpoint Composite Success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.8" lower_limit="55.3" upper_limit="69.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent Artery Stenosis &gt; 50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="1.2" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retreatment of Target Intracranial Aneurysm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.0" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up.</title>
        <description>Subjects experiencing neurologic death or major ipsilateral stroke through 12 months.</description>
        <time_frame>12 months</time_frame>
        <population>The mITT primary endpoint analysis population (n = 180) is based on subjects in the mITT arm and does not include the results of subjects treated in the Roll-in arm (n = 33).</population>
        <group_list>
          <group group_id="O1">
            <title>Surpass Flow Diverter (mITT)</title>
            <description>The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.</description>
          </group>
        </group_list>
        <measure>
          <title>mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up.</title>
          <description>Subjects experiencing neurologic death or major ipsilateral stroke through 12 months.</description>
          <population>The mITT primary endpoint analysis population (n = 180) is based on subjects in the mITT arm and does not include the results of subjects treated in the Roll-in arm (n = 33).</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="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Major Ipsilateral Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurological Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Primary Safety Endpoint Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure</title>
        <description>The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration (best); Class II: residual neck; Class III: residual aneurysm (worse).</description>
        <time_frame>12 months</time_frame>
        <population>mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Device Not Fully Apposed to Vessel Wall at 12 Months</title>
            <description>Subgroups of patients who did not have full apposition of the device to the vessel wall.</description>
          </group>
          <group group_id="O2">
            <title>Device Fully Apposed to Vessel Wall at 12 Months</title>
            <description>Subgroups of patients who had full apposition of the device to the vessel wall.</description>
          </group>
        </group_list>
        <measure>
          <title>Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure</title>
          <description>The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration (best); Class II: residual neck; Class III: residual aneurysm (worse).</description>
          <population>mITT population</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="34"/>
                <count group_id="O2" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Raymond-Roy I</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Raymond-Roy II</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Raymond-Roy III</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up</title>
        <description>Patients with minor strokes through 12 months</description>
        <time_frame>12 Months</time_frame>
        <population>Secondary endpoint analysis of the mITT population (n = 180) are presented herein for comparison to results of subjects in the Roll-in population (n = 33).</population>
        <group_list>
          <group group_id="O1">
            <title>Surpass Flow Diverter (mITT Population)</title>
            <description>The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.</description>
          </group>
          <group group_id="O2">
            <title>Surpass Flow Diverter (Roll-In Population)</title>
            <description>An additional 45 &quot;Roll-In&quot; subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 &quot;Roll-In&quot; and &quot;Enrolled but Not Treated&quot; subjects. Data from this population were not included in the mITT Primary Endpoint analysis. Neither did they serve as a control population. Results are displayed for informational purposes.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up</title>
          <description>Patients with minor strokes through 12 months</description>
          <population>Secondary endpoint analysis of the mITT population (n = 180) are presented herein for comparison to results of subjects in the Roll-in population (n = 33).</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="180"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus &lt; 65 Years in mITT Population</title>
        <description>Primary effectiveness by age group</description>
        <time_frame>12 Months</time_frame>
        <population>mITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Under Age 65</title>
            <description>Subjects below 65 years of age</description>
          </group>
          <group group_id="O2">
            <title>Age 65 and Older</title>
            <description>Subjects of at least 65 years of age</description>
          </group>
        </group_list>
        <measure>
          <title>Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus &lt; 65 Years in mITT Population</title>
          <description>Primary effectiveness by age group</description>
          <population>mITT population</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="114"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population</title>
        <description>Primary effectiveness by intracranial aneurysm size</description>
        <time_frame>12 Months</time_frame>
        <population>mITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>All Intracranial Aneurysm Sizes Except Giant</title>
            <description>Intracranial aneurysms not considered giant</description>
          </group>
          <group group_id="O2">
            <title>Giant Intracranial Aneurysms</title>
            <description>Intracranial aneurysms considered giant</description>
          </group>
        </group_list>
        <measure>
          <title>CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population</title>
          <description>Primary effectiveness by intracranial aneurysm size</description>
          <population>mITT Population</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="167"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations</title>
        <description>Number of devices implanted in subjects by study population</description>
        <time_frame>12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Surpass Flow Diverter (mITT)</title>
            <description>The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.</description>
          </group>
          <group group_id="O2">
            <title>Roll-In</title>
            <description>An additional 45 &quot;Roll-In&quot; subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 &quot;Roll-In&quot; and &quot;Enrolled but Not Treated&quot; subjects.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations</title>
          <description>Number of devices implanted in subjects by study population</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="180"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>One</title>
                  <measurement_list>
                    <measurement group_id="O1" value="156"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Two</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Post-Hoc Primary Safety Endpoint of Disabling Stroke or Neurologic Death Through 12 Month Follow-Up</title>
        <description>Subjects experiencing neurologic death or disabling stroke through 12 months.</description>
        <time_frame>12 Months</time_frame>
        <population>mITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Surpass Flow Diverter (mITT)</title>
            <description>The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-Hoc Primary Safety Endpoint of Disabling Stroke or Neurologic Death Through 12 Month Follow-Up</title>
          <description>Subjects experiencing neurologic death or disabling stroke through 12 months.</description>
          <population>mITT Population</population>
          <units>Percent of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Disabling Stroke or Neurologic Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" lower_limit="3.1" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurologic Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="0.9" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disabling Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" lower_limit="3.1" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through 12 Months Post Procedure</time_frame>
      <desc>The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.</desc>
      <group_list>
        <group group_id="E1">
          <title>Surpass Flow Diverter (mITT Population)</title>
          <description>The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.</description>
        </group>
        <group group_id="E2">
          <title>Surpass Flow Diverter (Roll-in Population)</title>
          <description>The Roll-in population was defined in the clinical protocol as all subjects who were enrolled as training cases and not considered part of the mITT population, and in whom the Surpass™ Flow Diverter entered the body regardless of whether or not the device was successfully implanted.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <default_assessment>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="5" subjects_at_risk="180"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="180"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Anginia Pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo Positional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Retinal Artery Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Retinal Infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Visual Impairment</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Optic Ischaemic Neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Papilloedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Visual Acuity Reduced</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Blindness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Hemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Retroperitoneal Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Thrombosis in Device</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Infusion Site Extravasation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Pseudocyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Device Occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Vascular Pseudo-Aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Optic Nerve Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Wrist Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Mental Status Changes Postoperative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Post Procedural Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Cerebral Salt-Wasting Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Carotid Artery Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Embolic Stroke</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hemorrhagic Stroke</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Ischemic Stroke</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="180"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Subarachnoid Hemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Transient Ischemic Attack</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Haemorrhage Intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>VIth Nerve Paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Thrombotic Stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Catatonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Renal Mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Pulmonary Mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Intra-Cerebral Aneurysm Operation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Aneurysm Repair</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Aortic Aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Arterial Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1.0</frequency_threshold>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="129" subjects_at_risk="180"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual Impairment</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="180"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Dry Eye</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Eye Pruritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Retinal Artery Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Retinal Hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Vitreous Floaters</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Pupils Unequal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="180"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="180"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Mouth Hemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Rectal Hemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Retroperitoneal Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Thrombosis in Device</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Catheter Site Hemorrhage</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Gait Disturbance</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Implant Site Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="180"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Traumatic Hematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Vascular Injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Vascular Pseudo-Aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neurological Examination Abnormal</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Carotid Bruit</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Groin Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Plantar Fasciitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Reversible Ischemic Neurological Deficit</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hypoesthesia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Transient Ischemic Attack</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Embolic Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Memory Impairment</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Carotid Artery Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Third Nerve Paralysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Restless Leg Syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="52" subjects_affected="52" subjects_at_risk="180"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Sleep Apnea Syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hemoptysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="180"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Vasospasm</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="180"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="180"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Orithostatic Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="180"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </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>Research parties agree not to make any publication of study results, including without limitation the study data, until completion of the study and publication of the multi-center results in a peer-reviewed journal. Thereafter, the research parties may publish their individual site experience.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Scott Courts, Clinical Program Manager</name_or_title>
      <organization>Stryker Neurovascular</organization>
      <phone>5104132170</phone>
      <email>scott.courts@stryker.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/NCT01716117
org study id: SP-04
nct id: NCT01716117
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This clinical research study is designed to determine safety and effectiveness of the Surpass
      Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large
      or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood
      vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left
      untreated, the bulge may continue to grow larger and ultimately the vessel may break open
      (rupture), resulting in serious bleeding into or around the brain. The information collected
      from this study will be used to evaluate how well patients do when treated with the Surpass
      System both immediately after treatment of an aneurysm and over a long period of time (5
      years).
The objective of this study is to determine safety and effectiveness of the Surpass Flow
      Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked
      intracranial aneurysms in the internal carotid artery up to the terminus. The Surpass Flow
      Diverter is an intracranial implant designed to be placed in a parent artery so as to divert
      blood flow away from an aneurysm. Use of the Surpass System may be associated with a decrease
      in neurological death or ipsilateral stroke in patients with large or giant wide-neck
      aneurysms. In a given patient, the Surpass System will be deemed effective if treatment
      results in complete occlusion of their aneurysm without clinically significant stenosis of
      the parent artery, or requires retreatment of the aneurysm through 12 months.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The SCENT Trial is a multi-center, prospective, non-randomized trial.
primary purpose: Treatment
masking: None (Open Label)
measure: mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit.
time frame: 12 months
description: Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.
measure: mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up.
time frame: 12 months
description: Subjects experiencing neurologic death or major ipsilateral stroke through 12 months.
measure: Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure
time frame: 12 months
description: The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration (best); Class II: residual neck; Class III: residual aneurysm (worse).
measure: Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up
time frame: 12 Months
description: Patients with minor strokes through 12 months
measure: Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population
time frame: 12 Months
description: Primary effectiveness by age group
measure: CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population
time frame: 12 Months
description: Primary effectiveness by intracranial aneurysm size
measure: Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations
time frame: 12 Months
description: Number of devices implanted in subjects by study population
arm group label: Surpass Flow Diverter
arm group type: Experimental
description: The objective of this study is to determine the safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus.
intervention type: Device
intervention name: Surpass Flow Diverter
description: Treatment of an intracranial aneurysm involves the placement of a specially designed metallic mesh tube in a vessel in the brain where an aneurysm is located. The device looks like a fishnet sock with both ends open. Each device is delivered through a small catheter (a long, flexible tube). The catheter containing the device is inserted and advanced into a vessel in the brain. The device is then placed in the brain vessel by releasing it from the catheter. Once the device is placed inside the brain vessel, it is intended to reinforce the area of the vessel that is weakened and bulging (the aneurysm), and to cause blood to flow down the vessel and away from the aneurysm while allowing blood in the aneurysm to clot. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels.
arm group label: Surpass Flow Diverter
other name: Flow diverter
other name: Endovascular aneurysm treatment
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ricardo A Hanel, MD, PhD
role: Principal Investigator
affiliation: Lyerly Baptist Medical Center, Jacksonville, Florida
last name: Philip M Meyers, MD
role: Principal Investigator
affiliation: Columbia University
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country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
mesh term: Calcium Carbonate
sharing ipd: No
ipd description: There is no plan to make IPD information available to other researchers. Blinded study data by mITT and Roll-in cohorts may be made available to SCENT researchers post publication of the primary study results.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 