<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/NCT03761173</url>
  </required_header>
  <id_info>
    <org_study_id>18-002</org_study_id>
    <nct_id>NCT03761173</nct_id>
  </id_info>
  <brief_title>FlowTriever All-Comer Registry for Patient Safety and Hemodynamics</brief_title>
  <acronym>FLASH</acronym>
  <official_title>FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inari Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inari Medical</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>
      To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of&#xD;
      emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use&#xD;
      of the device will be assessed in a real-world population, with eligibility criteria that&#xD;
      closely approximate its use in clinical practice.&#xD;
&#xD;
      Up to 300 additional patients with anticoagulation treatment as the initial planned primary&#xD;
      treatment strategy for intermediate risk PE will also be evaluated (US only).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>6 Months</target_duration>
  <primary_outcome>
    <measure>Composite Major Adverse Events</measure>
    <time_frame>48-hours</time_frame>
    <description>Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Individual Major Adverse Events</measure>
    <time_frame>48-hours</time_frame>
    <description>Rate of subjects with individual components of composite MAE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>30-days</time_frame>
    <description>Rate of deaths</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device-related serious adverse events</measure>
    <time_frame>30-days</time_frame>
    <description>Rate of device-related SAEs</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1300</enrollment>
  <condition>PE - Pulmonary Embolism</condition>
  <condition>PE - Pulmonary Thromboembolism</condition>
  <arm_group>
    <arm_group_label>FlowTriever</arm_group_label>
    <description>Mechanical thrombectomy for pulmonary embolism</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative Therapy Sub-Study</arm_group_label>
    <description>Anticoagulation medication for pulmonary embolism (as directed by treating physician)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FlowTriever System</intervention_name>
    <description>Thrombectomy</description>
    <arm_group_label>FlowTriever</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anticoagulation Agents</intervention_name>
    <description>Anticoagulation medication</description>
    <arm_group_label>Conservative Therapy Sub-Study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients requiring treatment for pulmonary embolism.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical signs and symptoms consistent with acute PE&#xD;
&#xD;
          -  Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least&#xD;
             one main or lobar pulmonary artery&#xD;
&#xD;
          -  Scheduled for PE treatment with the FlowTriever System per the Investigator's&#xD;
             discretion*&#xD;
&#xD;
               -  US only: Patients enrolled in the Conservative Therapy Sub-study are not required&#xD;
                  to meet this inclusion criteria but must instead be scheduled for primary&#xD;
                  anticoagulation therapy as the primary treatment strategy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to be anticoagulated with heparin or alternative&#xD;
&#xD;
          -  Diagnosis with a minor PE with a less than 0.9 RV/LV ratio&#xD;
&#xD;
          -  Known sensitivity to radiographic contrast agents that, in the Investigator's opinion,&#xD;
             cannot be adequately pre-treated*&#xD;
&#xD;
          -  Imaging evidence or other evidence that suggests, in the Investigator's opinion, the&#xD;
             subject is not appropriate for mechanical thrombectomy intervention*&#xD;
&#xD;
          -  Life expectancy &lt; 30 days, as determined by Investigator&#xD;
&#xD;
          -  Current participation in another investigational drug or device treatment study that,&#xD;
             in the Investigator's opinion, would interfere with participation in this study&#xD;
&#xD;
               -  US Only Patients enrolled in the Conservative Therapy Sub-study are not required&#xD;
                  to meet these exclusion criteria&#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>Catalin Toma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona College of Medicine</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Health Services</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Healthcare</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health Lousville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Providence Hospital</name>
      <address>
        <city>Madison Heights</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Providence Rochester Hospital</name>
      <address>
        <city>Rochester</city>
        <state>Michigan</state>
        <zip>48307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Health</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Mercy</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan Heart and Vascular Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CentraCare Heart &amp; Vascular Center</name>
      <address>
        <city>Saint Cloud</city>
        <state>Minnesota</state>
        <zip>56303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY, The 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>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</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>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexington Medical Center</name>
      <address>
        <city>West Columbia</city>
        <state>South Carolina</state>
        <zip>29169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Healthcare Foundation</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Thomas West</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora St. Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allgemeines Krankenhaus AKH Wien</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Antwerpen</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Besançon</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Cavale Blanche - CHU Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Coeur Poumon - CHU de Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCL Hôpital Louis Pradel - Hôpital Cardiologique</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>European Hospital Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardioangiologisches Centrum Bethanien</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum des Saarlandes</name>
      <address>
        <city>Homburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios Kliniken Schwerin</name>
      <address>
        <city>Schwerin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gregorio Maranon University Hospital</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Sankt Gallen</name>
      <address>
        <city>Saint Gallen</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unispital</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal London Hospital, Bart's Health</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PE</keyword>
  <keyword>pulmonary embolism</keyword>
  <keyword>thromboembolism</keyword>
  <keyword>thrombectomy</keyword>
  <keyword>FlowTriever</keyword>
  <keyword>Anticoagulation Medication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anticoagulants</mesh_term>
  </intervention_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/NCT03761173
org study id: 18-002
nct id: NCT03761173
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of
      emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use
      of the device will be assessed in a real-world population, with eligibility criteria that
      closely approximate its use in clinical practice.

      Up to 300 additional patients with anticoagulation treatment as the initial planned primary
      treatment strategy for intermediate risk PE will also be evaluated (US only).
observational model: Cohort
time perspective: Prospective
measure: Composite Major Adverse Events
time frame: 48-hours
description: Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events
measure: Individual Major Adverse Events
time frame: 48-hours
description: Rate of subjects with individual components of composite MAE
measure: All-cause mortality
time frame: 30-days
description: Rate of deaths
measure: Device-related serious adverse events
time frame: 30-days
description: Rate of device-related SAEs
arm group label: FlowTriever
description: Mechanical thrombectomy for pulmonary embolism
arm group label: Conservative Therapy Sub-Study
description: Anticoagulation medication for pulmonary embolism (as directed by treating physician)
intervention type: Device
intervention name: FlowTriever System
description: Thrombectomy
arm group label: FlowTriever
intervention type: Drug
intervention name: Anticoagulation Agents
description: Anticoagulation medication
arm group label: Conservative Therapy Sub-Study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catalin Toma, MD
role: Principal Investigator
affiliation: University of Pittsburgh
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country: Austria
country: Belgium
country: France
country: Germany
country: Netherlands
country: Spain
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Embolism
mesh term: Thromboembolism
mesh term: Anticoagulants
sharing ipd: Undecided