<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/NCT04451525</url>
  </required_header>
  <id_info>
    <org_study_id>CL11012</org_study_id>
    <nct_id>NCT04451525</nct_id>
  </id_info>
  <brief_title>REal-World Analyses of Stroke - Thrombus Occlusion REtrieval</brief_title>
  <acronym>&quot;RESTORE&quot;</acronym>
  <official_title>REal-World Analyses of Stroke - Thrombus Occlusion REtrieval</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Microvention-Terumo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Microvention-Terumo, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To collect real-world evidence allowing assessment of functional, imaging, and safety&#xD;
      outcomes of MicroVention market-released acute ischemic stroke devices when used at the&#xD;
      direction of the treating physician.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, single arm, observational, Real World Evidence (RWE)&#xD;
      post-market study with two cohorts.&#xD;
&#xD;
      The primary objective of Cohort I of the RESTORE study is to determine the proportion of&#xD;
      subjects achieving successful revascularization (mTICI ≥ 2b) with the SOFIA® Flow Plus 6F&#xD;
      Aspiration Catheter when used in conjunction with the direct aspiration as first line&#xD;
      treatment technique for patients with acute ischemic stroke in the anterior circulation based&#xD;
      on collection of real-world evidence data. Secondary objectives include the evaluation of&#xD;
      good functional outcome (defined as mRS ≤ 2 at day 90), revascularization time, and procedure&#xD;
      related major neurological complications, all based on real-world evidence data collected.&#xD;
&#xD;
      The objective of Cohort II of the study is to evaluate standard outcomes such as successful&#xD;
      revascularization (mTICI ≥ 2b), good functional outcome (defined as mRS ≤ 2 at day 90),&#xD;
      revascularization time, and procedure related major neurological complications based on&#xD;
      real-world evidence data. Additional outcomes may be defined and research questions generated&#xD;
      based on review of the collected data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cohort I: Proportion of subjects achieving mTICI ≥ 2b revascularization based on independent core lab assessment</measure>
    <time_frame>During the procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with good functional outcome defined as mRS ≤ 2</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of procedure related serious adverse events</measure>
    <time_frame>During the procedure through study completion at 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of sICH within 24 hours</measure>
    <time_frame>24 hours post-operative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of embolization to new territories (ENT)</measure>
    <time_frame>During the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of vasospasm involving the accessed vascular tree</measure>
    <time_frame>During the procedure through 24 hours post-operative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality at day 90</measure>
    <time_frame>90 days post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects achieving mTICI ≥ 2b revascularization after first line aspiration treatment</measure>
    <time_frame>During the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of passes to achieve mTICI ≥ 2b revascularization with first line aspiration treatment</measure>
    <time_frame>During the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects achieving mTICI ≥ 2b revascularization after first aspiration pass</measure>
    <time_frame>During the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from groin puncture to initial contact of clot with aspiration catheter</measure>
    <time_frame>During the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from groin puncture to achieve mTICI ≥ 2b using first line aspiration treatment</measure>
    <time_frame>During the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success using the MicroVention BOBBY Balloon Guide Catheter based on successful placement at the target location and successful balloon inflation</measure>
    <time_frame>During the procedure</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <condition>Vessel Occlusion</condition>
  <condition>Stroke</condition>
  <condition>Ischemic</condition>
  <arm_group>
    <arm_group_label>Cohort I</arm_group_label>
    <description>Cohort I will focus on data collection on the SOFIA® Flow Plus 6F Aspiration Catheter used with the direct aspiration as first line treatment technique with the intent to evaluate per prespecified endpoints.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort II</arm_group_label>
    <description>Cohort II will focus on data collection on MicroVention devices used for acute ischemic stroke treatment with the intent to evaluate standard outcomes while also generating additional research questions for analysis based on data collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MicroVention Mechanical Thrombectomy Devices as first-line treatment</intervention_name>
    <description>Patient will be treated with mechanical thrombectomy at the direction of the treating physician</description>
    <arm_group_label>Cohort I</arm_group_label>
    <arm_group_label>Cohort II</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with acute ischemic stroke in the cerebral circulation who will be treated with&#xD;
        mechanical thrombectomy at the direction of the treating physician.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Cohort I:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is ≥ 21 and ≤ 85 years of age.&#xD;
&#xD;
          2. Patient has a pre-morbid mRS ≤ 1.&#xD;
&#xD;
          3. Neuroimaging (CT/CTA and/or MR/MRA collected at no more than 90 minutes prior to groin&#xD;
             puncture) demonstrates large vessel proximal occlusion (distal ICA through MCA&#xD;
             bifurcation).&#xD;
&#xD;
          4. Patient has an NIHSS score ≥ 5 at time of intervention.&#xD;
&#xD;
          5. Symptom onset is within 8 hours of when groin puncture can be achieved.&#xD;
&#xD;
          6. Patient will undergo treatment via femoral access and the decision to use femoral&#xD;
             access has been made by the treating physician outside the context of the RESTORE&#xD;
             study and prior to study enrollment.&#xD;
&#xD;
          7. Patient will be treated using the direct aspiration as first line treatment technique&#xD;
             and the decision to use this technique and the study device has been made by the&#xD;
             treating physician outside the context of the RESTORE study and prior to study&#xD;
             enrollment.&#xD;
&#xD;
          8. Patient or patient's legally authorized representative (LAR) has provided written&#xD;
             informed consent.&#xD;
&#xD;
          9. Patient is considered by the treating physician to be available for and able to&#xD;
             complete all follow-up visits with a trained site investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to obtain written informed consent.&#xD;
&#xD;
          2. Patient is &lt; 21 or &gt; 85 years of age.&#xD;
&#xD;
          3. Patient has a pre-morbid mRS ≥ 2.&#xD;
&#xD;
          4. More than 8 hours have passed since symptom onset.&#xD;
&#xD;
          5. Severe unilateral or bilateral carotid artery stenosis or dissection requiring stent&#xD;
             treatment.&#xD;
&#xD;
          6. Presence of a pre-existing large territory infarction.&#xD;
&#xD;
          7. Absent femoral pulses or other condition preventing femoral access.&#xD;
&#xD;
          8. Patient has vascular anatomy/tortuosity or other vascular disease preventing access to&#xD;
             the target occlusion or that will likely result in unstable access.&#xD;
&#xD;
          9. Patient is pregnant.&#xD;
&#xD;
         10. Known or suspected pre-existing/chronic large vessel occlusion in the symptomatic&#xD;
             territory.&#xD;
&#xD;
         11. Patient has known, untreatable hypersensitivity to contrast dye, iodine or any&#xD;
             component of the treatment device that cannot be medically controlled.&#xD;
&#xD;
         12. The intracranial occlusion is suspected to be chronic based on past imaging, clinical&#xD;
             history, or clinical judgment.&#xD;
&#xD;
         13. Patient has a severe or life-threatening comorbidity that could confound study&#xD;
             results, or that will render the procedure unlikely to benefit the patient.&#xD;
&#xD;
         14. Patient is unable to complete scheduled follow-up assessments due to comorbidities,&#xD;
             geographical limitations, or a life expectancy of less than 3 months.&#xD;
&#xD;
         15. Patient is enrolled in another device or drug study in which participation could&#xD;
             confound study results.&#xD;
&#xD;
         16. Imaging (CT or MR) exclusion criteria:&#xD;
&#xD;
               -  Presence of intracerebral hemorrhage as evidenced on initial imaging&#xD;
&#xD;
               -  Ischemic changes in the posterior circulation territories (including the&#xD;
                  vertebra-basilar and posterior cerebral arteries)&#xD;
&#xD;
               -  Significant mass effect with midline shift&#xD;
&#xD;
               -  Evidence of intracranial tumor&#xD;
&#xD;
               -  Baseline ischemic core lesion &gt;50 cc&#xD;
&#xD;
               -  Involvement of &gt; 1/3 of the middle cerebral artery territory&#xD;
&#xD;
               -  ASPECTS &lt;6 (hemispheric sulcal effacement and/or loss of grey-white&#xD;
                  differentiation alone are not contraindications for treatment)&#xD;
&#xD;
        Cohort II:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Neuroimaging (CT/CTA and/or MR/MRA) demonstrates intracranial vessel occlusion.&#xD;
&#xD;
          2. Symptom onset is within 24 hours of when arterial access puncture can be achieved.&#xD;
&#xD;
          3. Patient will be treated using an FDA-cleared/approved and market-released MicroVention&#xD;
             mechanical thrombectomy device as the initial, primary treatment device and the&#xD;
             decision to use this device has been made by the treating physician outside the&#xD;
             context of the RESTORE study and prior to study enrollment.&#xD;
&#xD;
             Note: For the purposes of this protocol, ancillary/accessory devices such as balloon&#xD;
             guide catheters and other access devices are not considered primary treatment devices.&#xD;
             Further, devices used for rescue following attempt of a different primary treatment&#xD;
             device are not considered initial primary treatment devices.&#xD;
&#xD;
          4. Patient or patient's legally authorized representative (LAR) has provided written&#xD;
             informed consent within 48 hours of procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to obtain written informed consent within 48 hours of procedure.&#xD;
&#xD;
          2. Patient is enrolled in another device or drug study in which participation could&#xD;
             confound study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dheeraj Gandhi, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, Baltimore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mary Schmitz, Sr. Project Manager</last_name>
    <phone>949-867-0798</phone>
    <email>mary.schmitz@microvention.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ophelia Selam</last_name>
    <email>ophelia.selam@microvention.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mercy San Juan - Dignity Health Research Institute</name>
      <address>
        <city>Carmichael</city>
        <state>California</state>
        <zip>95608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Danielle Hornbuckle</last_name>
    </contact>
    <investigator>
      <last_name>Lucian Maidan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCHealth Memorial</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelsey Hartle</last_name>
    </contact>
    <investigator>
      <last_name>Ricky Medel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Healthcare System</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pamela Shaw</last_name>
    </contact>
    <investigator>
      <last_name>Norman Ajiboye, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patty Ray</last_name>
    </contact>
    <investigator>
      <last_name>Scott Rahimi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Goodman Campbell Brain and Spine</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Vance</last_name>
    </contact>
    <investigator>
      <last_name>Daniel Sahlein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charlesa Plummer</last_name>
    </contact>
    <investigator>
      <last_name>Timothy Miller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anni Jiaying Schwab Bell</last_name>
    </contact>
    <investigator>
      <last_name>Mohammad A Aziz-Sultan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ascension Borgess</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kali Barrow</last_name>
    </contact>
    <investigator>
      <last_name>Kenneth Kreitel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>SSM Health</name>
      <address>
        <city>Bridgeton</city>
        <state>Missouri</state>
        <zip>63044</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Makenzie Woodford</last_name>
    </contact>
    <investigator>
      <last_name>Amer Alshekhlee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Randolph</last_name>
    </contact>
    <investigator>
      <last_name>Farhan Siddiq, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Reed</last_name>
    </contact>
    <investigator>
      <last_name>Rano Chatterjee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northshore University Hospital - Northwell</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Kozikowski</last_name>
    </contact>
    <investigator>
      <last_name>Henry Woo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stony Brook Medicine</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dawn Madigan</last_name>
    </contact>
    <investigator>
      <last_name>David Fiorella, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Sayles</last_name>
    </contact>
    <investigator>
      <last_name>Charles Prestigiacomo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lauren Todd</last_name>
    </contact>
    <investigator>
      <last_name>Gabor Toth, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ProMedica Toledo</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stacy Parlette</last_name>
    </contact>
    <investigator>
      <last_name>Syed Zaidi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Geisinger</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chelsie Derr</last_name>
    </contact>
    <investigator>
      <last_name>Clemens Schirmer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Upstate</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sean Mcdermott</last_name>
    </contact>
    <investigator>
      <last_name>Imran Chaudry, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford Medical Center</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karla Reilly</last_name>
    </contact>
    <investigator>
      <last_name>Divyajot Sandhu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>INOVA</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karlie Smith</last_name>
    </contact>
    <investigator>
      <last_name>Manuel Fortes, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Swedish Health Services</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janae Rahiman</last_name>
    </contact>
    <investigator>
      <last_name>Yince Loh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mechanical Thrombectomy, Aspiration, SOFIA®, Direct Aspiration, ERIC®</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451525
org study id: CL11012
nct id: NCT04451525
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To collect real-world evidence allowing assessment of functional, imaging, and safety
      outcomes of MicroVention market-released acute ischemic stroke devices when used at the
      direction of the treating physician.
This is a prospective, multi-center, single arm, observational, Real World Evidence (RWE)
      post-market study with two cohorts.

      The primary objective of Cohort I of the RESTORE study is to determine the proportion of
      subjects achieving successful revascularization (mTICI ≥ 2b) with the SOFIA® Flow Plus 6F
      Aspiration Catheter when used in conjunction with the direct aspiration as first line
      treatment technique for patients with acute ischemic stroke in the anterior circulation based
      on collection of real-world evidence data. Secondary objectives include the evaluation of
      good functional outcome (defined as mRS ≤ 2 at day 90), revascularization time, and procedure
      related major neurological complications, all based on real-world evidence data collected.

      The objective of Cohort II of the study is to evaluate standard outcomes such as successful
      revascularization (mTICI ≥ 2b), good functional outcome (defined as mRS ≤ 2 at day 90),
      revascularization time, and procedure related major neurological complications based on
      real-world evidence data. Additional outcomes may be defined and research questions generated
      based on review of the collected data.
observational model: Cohort
time perspective: Prospective
measure: Cohort I: Proportion of subjects achieving mTICI ≥ 2b revascularization based on independent core lab assessment
time frame: During the procedure
measure: Proportion of subjects with good functional outcome defined as mRS ≤ 2
time frame: 90 days
measure: Occurrence of procedure related serious adverse events
time frame: During the procedure through study completion at 90 days
measure: Occurrence of sICH within 24 hours
time frame: 24 hours post-operative
measure: Occurrence of embolization to new territories (ENT)
time frame: During the procedure
measure: Presence of vasospasm involving the accessed vascular tree
time frame: During the procedure through 24 hours post-operative
measure: Mortality at day 90
time frame: 90 days post-procedure
measure: Proportion of subjects achieving mTICI ≥ 2b revascularization after first line aspiration treatment
time frame: During the procedure
measure: Number of passes to achieve mTICI ≥ 2b revascularization with first line aspiration treatment
time frame: During the procedure
measure: Proportion of subjects achieving mTICI ≥ 2b revascularization after first aspiration pass
time frame: During the procedure
measure: Time from groin puncture to initial contact of clot with aspiration catheter
time frame: During the procedure
measure: Time from groin puncture to achieve mTICI ≥ 2b using first line aspiration treatment
time frame: During the procedure
measure: Technical success using the MicroVention BOBBY Balloon Guide Catheter based on successful placement at the target location and successful balloon inflation
time frame: During the procedure
arm group label: Cohort I
description: Cohort I will focus on data collection on the SOFIA® Flow Plus 6F Aspiration Catheter used with the direct aspiration as first line treatment technique with the intent to evaluate per prespecified endpoints.
arm group label: Cohort II
description: Cohort II will focus on data collection on MicroVention devices used for acute ischemic stroke treatment with the intent to evaluate standard outcomes while also generating additional research questions for analysis based on data collected.
intervention type: Device
intervention name: MicroVention Mechanical Thrombectomy Devices as first-line treatment
description: Patient will be treated with mechanical thrombectomy at the direction of the treating physician
arm group label: Cohort I
arm group label: Cohort II
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dheeraj Gandhi, MBBS, MD
role: Principal Investigator
affiliation: University of Maryland, Baltimore
last name: Mary Schmitz, Sr. Project Manager
phone: 949-867-0798
email: mary.schmitz@microvention.com
last name: Ophelia Selam
email: ophelia.selam@microvention.com
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country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Ischemia
sharing ipd: Undecided