<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/NCT02186223</url>
  </required_header>
  <id_info>
    <org_study_id>QD-230</org_study_id>
    <nct_id>NCT02186223</nct_id>
  </id_info>
  <brief_title>The Angel® Catheter Pivotal Clinical Trial</brief_title>
  <official_title>The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BiO2 Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CardioMed Device Consultants, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Intrinsic Imaging, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novella Clinical</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>BiO2 Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this multicenter, prospective, single arm clinical trial is to&#xD;
      evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE,&#xD;
      and with recognized contraindications to standard pharmacological therapy (anticoagulation).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom From Clinically Significant PE or Fatal PE During Treatment Period</measure>
    <time_frame>Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)</time_frame>
    <description>Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE.&#xD;
Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Acute Proximal Deep Vein Thrombosis</measure>
    <time_frame>Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Catheter Related Thrombosis</measure>
    <time_frame>Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Catheter Related Blood Stream Infections</measure>
    <time_frame>Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Major Bleeding Event</measure>
    <time_frame>Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of PEs Averted</measure>
    <time_frame>During the pre-removal cavogram (An average of 6.8 days after device insertion)</time_frame>
    <description>During the pre-removal cavogram, the presence of significant clot (&gt;25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>Pulmonary Embolism</condition>
  <condition>Deep Vein Thrombosis</condition>
  <condition>Venous Thromboembolism</condition>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>The Angel® Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All eligible subjects will receive an Angel® Catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Angel® Catheter</intervention_name>
    <description>The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.</description>
    <arm_group_label>The Angel® Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject or legally authorized representative is willing and able to provide written&#xD;
             informed consent,&#xD;
&#xD;
          2. Subject is 18 years or older,&#xD;
&#xD;
          3. Subject is expected to remain in a critical care setting for at least 72 hours,&#xD;
&#xD;
             AND at least one of the following inclusion criteria (4,5, and/or 6)&#xD;
&#xD;
          4. Subject has recognized contraindications to standard pharmacological&#xD;
             thromboprophylaxis including:&#xD;
&#xD;
               -  Active bleeding or at high risk for bleeding OR&#xD;
&#xD;
               -  Hypersensitivity to pharmacological thromboprophylaxis OR&#xD;
&#xD;
               -  History of severe heparin induced thrombocytopenia OR&#xD;
&#xD;
               -  Severe thrombocytopenia&#xD;
&#xD;
          5. Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE&#xD;
             with recognized contraindication to anticoagulation&#xD;
&#xD;
          6. Subject requires a temporary interruption (&gt;24 hours) of pharmacological&#xD;
             thromboprophylaxis for a surgical or medical procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is pregnant&#xD;
&#xD;
          2. Subject is in treatment with an investigational drug or device within 30 days prior to&#xD;
             enrollment&#xD;
&#xD;
          3. Subject has a pre-existing IVC filter in place&#xD;
&#xD;
          4. BMI = &gt; 45&#xD;
&#xD;
          5. Subject has functioning pelvic renal allograft on the only side available for device&#xD;
             insertion&#xD;
&#xD;
          6. Subject has undergone a surgical procedure involving the femoral vein or pelvic veins&#xD;
             through which the device must be inserted&#xD;
&#xD;
          7. Anatomic inability to place the Angel® Catheter&#xD;
&#xD;
          8. Subject has known hypersensitivity to any of the components of the Angel® Catheter,&#xD;
             specifically Nitinol (nickel and/or titanium)&#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>Victor Tapson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of the Rockies</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delray Medical Center</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33483</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broward Health Medical Center</name>
      <address>
        <city>Ft. Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Shands Cancer Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Memorial Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Medical Center</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital St. Louis</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper University Hospital</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Health</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's University Health Network</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</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>Regional One Health</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</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>John Peter Smith Health Network</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ben Taub Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>December 14, 2016</results_first_submitted>
  <results_first_submitted_qc>February 17, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 4, 2017</results_first_posted>
  <last_update_submitted>February 17, 2017</last_update_submitted>
  <last_update_submitted_qc>February 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary Embolism</keyword>
  <keyword>PE</keyword>
  <keyword>DVT</keyword>
  <keyword>Deep Vein Thrombosis</keyword>
  <keyword>VTE</keyword>
  <keyword>Venous Thromboembolism</keyword>
  <keyword>prophylaxis</keyword>
  <keyword>thromboprophylaxis</keyword>
  <keyword>contraindications to thromboprophylaxis</keyword>
  <keyword>prophylactic</keyword>
  <keyword>prevention</keyword>
  <keyword>Inferior vena cava filter</keyword>
  <keyword>IVC filter</keyword>
  <keyword>filter</keyword>
  <keyword>prevention of pulmonary embolism</keyword>
  <keyword>trauma</keyword>
  <keyword>critically-ill</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>The Angel® Catheter</title>
          <description>All eligible subjects will receive an Angel® Catheter.&#xD;
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Device Placed</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="151"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not eligible for device placement</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to obtain femoral access</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Device in place less than 48 hours</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Population includes all subjects that had the Angel® Catheter placed.</population>
      <group_list>
        <group group_id="B1">
          <title>The Angel® Catheter</title>
          <description>All eligible subjects received an Angel® Catheter.&#xD;
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="163"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.07" spread="18.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43" lower_limit="18" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from admission to the hospital to admission to ICU</title>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.49" spread="27.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from admission to the hospital to admission to ICU</title>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.07" lower_limit="0" upper_limit="292.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary ICU Admission Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Trauma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surgical</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medical</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurological</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of trauma (for trauma subjects)</title>
          <population>Number analyzed includes all trauma subjects that had an Angel® Catheter placed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Head/Spinal Trauma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chest</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lower Extremity Trauma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one area affected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head Bleed (Subcategory of Head/Spinal Trauma)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Injury Severity Score (for trauma subjects)</title>
          <description>Injury Severity Score (ISS) Scale: Minimal (1-9); Moderate (10-15); Severe (16-24); Critical (25+); Trauma subjects categorized by their ISS, with higher scores representing more serious/life-threating injuries. This anatomical scoring system providing an overall score for patients with multiple injuries. Each injury is assigned an Abbreviated Injury Scale (AIS) score and allocated to 1/6 body regions (Head, Face, Chest, Abdomen, Extremities &amp; Pelvis, External). Highest score in each body region is used. 3 most severely injured regions have score squared and added to produce the ISS score.</description>
          <population>Measure Analysis is specific only to trauma subjects.</population>
          <units>Injury Severity Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.68" spread="11.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Injury Severity Score (for trauma subjects)</title>
          <population>Number analyzed includes all trauma subjects that had an Angel® Catheter placed</population>
          <units>Injury Severity Score</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26" lower_limit="5" upper_limit="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Injury Classification</title>
          <description>Trauma subjects were categorized based on their Injury Severity Score (ISS), with higher scores representing more serious or life-threating injuries. The ISS is an anatomical scoring system that provides an overall score for patients with multiple injuries. Each injury is assigned an Abbreviated Injury Scale (AIS) score and allocated to one of six body regions (Head, Face, Chest, Abdomen, Extremities (including Pelvis), External). The highest AIS score in each body region is used. The 3 most severely injured body regions have their score squared and added together to produce the ISS score.</description>
          <population>Number analyzed includes all trauma subjects that had the Angel® Catheter placed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Minimal (1-9)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate (10-15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe (16-24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Critical (25+)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Bleeding Risk</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Active bleeding</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>History of bleeding</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At high risk for bleeding</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Severity of Active Bleeding</title>
          <population>Number analyzed includes all subjects with active bleeding at enrollment and subsequently had an Angel® Catheter placed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Minor bleeding</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Major bleeding</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical History &amp; Concomitant Conditions</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Blood and lymphatic system disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endocrine disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear and labyrinth disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eye disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General disorders and administration site conditio</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatobiliary disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immune system disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infections and infestations</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injury, poisoning, and procedural complications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Investigations</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolism and nutrition disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Musculoskeletal and connective tissue disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neoplasms benign, malignant, and unspecified</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nervous system disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychiatric disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal and urinary disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reproductive system and breast disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory, thoracic and mediastinal disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin and subcutaneous tissue disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social circumstances</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surgical and medical procedures</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vascular disorders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Subjects with Baseline Venous Thromboembolic (VTE) Disease per Site-reported Medical History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Pulmonary Embolism (PE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deep Vein Thrombosis (DVT)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PE and DVT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Use of mechanical DVT preventive devices</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>At least 1 type of preventive device used</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Compressive stockings</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pneumatic compression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Supplemental Oxygen at Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of supplemental oxygen</title>
          <population>Number analyzed includes all patient receiving supplemental oxygen at enrollment that subsequently had an Angel® Catheter placed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Mechanical ventilation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CPAP-BiPAP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal cannula/face mask</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Need for vasopressors before Angel® Catheter insertion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Other Central Venous Catheter (CVC) in place prior to Angel® Catheter insertion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Short term CVC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Long term CVC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Indications for the Angel® Catheter Placement</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Recognized contraindications to anticoagulation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute LE DVT or PE &amp; contraindicated to anticoagul</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temporary interruption of anticoagulation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prophylactic Use of Indications for the Angel® Cat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Contraindications to anticoagulation</title>
          <population>Number analyzed includes all subjects that had recognized contraindications to standard pharmacological thromboprophylaxis reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Active or high risk for bleeding</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypersensitivity to anticoagulation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>History of severe heparin induced thrombocytopenia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe thrombocytopenia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Freedom From Clinically Significant PE or Fatal PE During Treatment Period</title>
        <description>Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE.&#xD;
Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.</description>
        <time_frame>Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>The Angel® Catheter</title>
            <description>All eligible subjects received an Angel® Catheter.&#xD;
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.</description>
          </group>
        </group_list>
        <measure>
          <title>Freedom From Clinically Significant PE or Fatal PE During Treatment Period</title>
          <description>Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE.&#xD;
Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.</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="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Acute Proximal Deep Vein Thrombosis</title>
        <time_frame>Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>The Angel® Catheter</title>
            <description>All eligible subjects received an Angel® Catheter.&#xD;
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Acute Proximal Deep Vein Thrombosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Catheter Related Thrombosis</title>
        <time_frame>Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>The Angel® Catheter</title>
            <description>All eligible subjects received an Angel® Catheter.&#xD;
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Catheter Related Thrombosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Catheter Related Blood Stream Infections</title>
        <time_frame>Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>The Angel® Catheter</title>
            <description>All eligible subjects received an Angel® Catheter.&#xD;
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Catheter Related Blood Stream Infections</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Major Bleeding Event</title>
        <time_frame>Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>The Angel® Catheter</title>
            <description>All eligible subjects received an Angel® Catheter.&#xD;
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Major Bleeding Event</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of PEs Averted</title>
        <description>During the pre-removal cavogram, the presence of significant clot (&gt;25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.</description>
        <time_frame>During the pre-removal cavogram (An average of 6.8 days after device insertion)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Angel® Catheter Pre-Removal Cavogram</title>
            <description>Number analyzed includes all subjects that had an Angel® Catheter placed, and a cavogram was performed prior to removal.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of PEs Averted</title>
          <description>During the pre-removal cavogram, the presence of significant clot (&gt;25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.</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="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>The Angel® Catheter</title>
          <description>All eligible subjects received an Angel® Catheter.&#xD;
The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Supraventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Brain Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Multi-Organ Failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic Hepatic Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Lobar Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Craniocerebral Injury</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Post Procedural Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Subdural Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Brain Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Haemorrhage Intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Intracranial Pressure Increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="163"/>
              </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="163"/>
              </event>
              <event>
                <sub_title>Renal Failure Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Distress Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Haemodynamic Instability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pelvic Venous Thrombosis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Vena Cava Thrombosis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="114" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cyanosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes insipidus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Scleral oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Gastric hypomotility</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Gastrointestinal sounds abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Device damage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Device deployment issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Unintentional medical device removal</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acinetobacter infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Central nervous system infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Gastrointestinal bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Lobar pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Meningitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonia klebsiella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonia psudomonal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Wound infection pseudomonas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Wound sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anastomotic leak</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Diffuse axonal injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Clostridium test positive</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Culture urine positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Klebsiella test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pulse absent</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Glucose tolerance impaired</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Compartment syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Muscle haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Muscle necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Autonomic nervous system imbalance</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cerebral hypoperfusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Intracranial pressure increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Mental impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Neurological symptom</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Myoglobinuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Bronchial secretion retention</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hyercapnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Accelerated hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Axillary vein thrombosis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Femoral artery occlusion</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Pelvic venous thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Platelet count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Secondary hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Subclavian vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="163"/>
              </event>
              <event>
                <sub_title>Vena cava thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="163"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Bio2 Medical, Inc.</organization>
      <phone>720-833-5675</phone>
      <email>langel@bio2medical.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/NCT02186223
org study id: QD-230
nct id: NCT02186223
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The primary objective of this multicenter, prospective, single arm clinical trial is to
      evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE,
      and with recognized contraindications to standard pharmacological therapy (anticoagulation).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Freedom From Clinically Significant PE or Fatal PE During Treatment Period
time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)
description: Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE.
Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death.
measure: Incidence of Acute Proximal Deep Vein Thrombosis
time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
measure: Incidence of Catheter Related Thrombosis
time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
measure: Incidence of Catheter Related Blood Stream Infections
time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
measure: Incidence of Major Bleeding Event
time frame: Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)
measure: Incidence of PEs Averted
time frame: During the pre-removal cavogram (An average of 6.8 days after device insertion)
description: During the pre-removal cavogram, the presence of significant clot (>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.
arm group label: The Angel® Catheter
arm group type: Experimental
description: All eligible subjects will receive an Angel® Catheter.
intervention type: Device
intervention name: The Angel® Catheter
description: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
arm group label: The Angel® Catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Victor Tapson, MD
role: Principal Investigator
affiliation: Cedars Sinai
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Thrombosis
mesh term: Embolism
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Venous Thrombosis
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 