<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/NCT04416659</url>
  </required_header>
  <id_info>
    <org_study_id>3002</org_study_id>
    <nct_id>NCT04416659</nct_id>
  </id_info>
  <brief_title>Flow Arrest Safety and Technical Success With Balloon Guide Catheters</brief_title>
  <acronym>FAST-BGC</acronym>
  <official_title>Flow Arrest Safety and Technical Success With Balloon Guide Catheters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Neurovascular Clinical Affairs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Neurovascular Clinical Affairs</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this post-market registry is to assess technical efficacy and safety&#xD;
      associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures&#xD;
      while providing temporary arrest of blood flow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, non-randomized observational registry evaluating use of&#xD;
      BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large&#xD;
      intracranial vessel occlusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2021</start_date>
  <completion_date type="Actual">October 27, 2021</completion_date>
  <primary_completion_date type="Actual">October 27, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Week</target_duration>
  <primary_outcome>
    <measure>Safety Evaluation</measure>
    <time_frame>Hospital discharge or 7 days</time_frame>
    <description>Incidence of device-related adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance Evaluation</measure>
    <time_frame>Completion of procedure</time_frame>
    <description>Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment</description>
  </primary_outcome>
  <enrollment type="Actual">52</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuro-vascular access</intervention_name>
    <description>Adjunctive device providing a conduit for retrieval device during thrombectomy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute ischemic stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute ischemic stroke vessel occlusion (ICA, M1 or M2) of the anterior circulation&#xD;
             with associated symptoms&#xD;
&#xD;
          -  Adult patient willing to provide Informed Consent&#xD;
&#xD;
          -  Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Posterior circulation stroke&#xD;
&#xD;
          -  Tandem occlusions&#xD;
&#xD;
          -  Cervical carotid stenosis&#xD;
&#xD;
          -  Participating in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Biraj Patel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carilion Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BNI (St. Joseph's Hospital-Dignity Health)</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish-RIACO</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KUMC</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMass Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ft Sanders Regional Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carilion Clinic</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be available.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04416659
org study id: 3002
nct id: NCT04416659
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this post-market registry is to assess technical efficacy and safety
      associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures
      while providing temporary arrest of blood flow.
This is a prospective, multi-center, non-randomized observational registry evaluating use of
      BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large
      intracranial vessel occlusion.
observational model: Cohort
time perspective: Prospective
measure: Safety Evaluation
time frame: Hospital discharge or 7 days
description: Incidence of device-related adverse events
measure: Performance Evaluation
time frame: Completion of procedure
description: Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment
intervention type: Device
intervention name: Neuro-vascular access
description: Adjunctive device providing a conduit for retrieval device during thrombectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Biraj Patel, MD
role: Principal Investigator
affiliation: Carilion Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ischemic Stroke
sharing ipd: No
ipd description: No IPD will be available.