<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/NCT03286400</url>
  </required_header>
  <id_info>
    <org_study_id>TAG 15-03</org_study_id>
    <nct_id>NCT03286400</nct_id>
  </id_info>
  <brief_title>Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL</brief_title>
  <acronym>SURPASS</acronym>
  <official_title>Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>W.L.Gore &amp; Associates</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>W.L.Gore &amp; Associates</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable&#xD;
      Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the&#xD;
      treatment of aortic disease as part of routine clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational, prospective, single-arm, post-market registry designed to collect&#xD;
      real-world clinical and device specific outcomes of the GORE® TAG® Conformable Thoracic Stent&#xD;
      Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of&#xD;
      aortic disease as part of routine clinical practice. A maximum of 20 clinical investigative&#xD;
      sites in Europe will participate and up to 125 patients will be enrolled in this registry.&#xD;
      All consecutive patients meeting protocol selection criteria, consented, with an intention to&#xD;
      be treated with the CTAG Device with ACTIVE CONTROL will be included and followed through one&#xD;
      year per institutional standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2017</start_date>
  <completion_date type="Actual">October 9, 2019</completion_date>
  <primary_completion_date type="Actual">October 9, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Number of Subjects With Procedural Technical Success</measure>
    <time_frame>24 hours</time_frame>
    <description>Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects With Treatment Success at 30 Day Visit</measure>
    <time_frame>One month</time_frame>
    <description>Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Freedom From Major Adverse Events at 30 Days</measure>
    <time_frame>30 Days</time_frame>
    <description>Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Freedom From Major Adverse Events at 12 Months</measure>
    <time_frame>12 Months</time_frame>
    <description>Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Treatment Success at 12 Month Visit</measure>
    <time_frame>One year</time_frame>
    <description>Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events</measure>
    <time_frame>Days 30, 365, and 455</time_frame>
    <description>Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion</measure>
    <time_frame>One year</time_frame>
    <description>One year change from first post-implant CT scan in maximum aortic diameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maximum False Lumen Diameter Among Dissection</measure>
    <time_frame>One year</time_frame>
    <description>One year change from first post-implant CT scan in maximum false lumen diameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Minimum True Lumen Diameter Among Dissection</measure>
    <time_frame>One year</time_frame>
    <description>One year change from first post-implant CT scan in minimum true lumen diameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maximum Aortic Diameter Among Dissection</measure>
    <time_frame>One year</time_frame>
    <description>One year change from first post-implant CT scan in maximum aortic diameter</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>Thoracic Diseases</condition>
  <arm_group>
    <arm_group_label>CTAG Device with ACTIVE CONTROL</arm_group_label>
    <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CTAG Device with ACTIVE CONTROL</intervention_name>
    <description>Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
    <arm_group_label>CTAG Device with ACTIVE CONTROL</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients presenting with an indication for endovascular repair of the&#xD;
        thoracic aorta are eligible for screening for participation in the registry. Only patients&#xD;
        who meet all inclusion and no exclusion criteria, and who consent to participate will be&#xD;
        enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Signed informed consent form&#xD;
&#xD;
          3. Willingness, in the opinion of the investigator, to adhere to standard of care&#xD;
             follow-up requirements&#xD;
&#xD;
          4. Surgical indication for TEVAR based on investigator's best medical judgment&#xD;
&#xD;
          5. Intent to treat with CTAG Device with ACTIVE CONTROL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Paraplegia or paraparesis at initial presentation&#xD;
&#xD;
          2. Participation in concurrent research study or registry which may confound registry&#xD;
             results, unless approved by Sponsor&#xD;
&#xD;
          3. Prior implantation of a thoracic stent graft&#xD;
&#xD;
          4. Pregnant or breast-feeding female at time of informed consent signature&#xD;
&#xD;
          5. Life expectancy &lt; 1 year due to comorbidities&#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>Giovanni Torsello, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Franziskus Hospital GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Köln</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Franziskus Hospital GmbH</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Regensburg</name>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Civili Brescia</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedali dei Colli - Monaldi</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliers San Camilla Forlanni</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Santiago de Compostela</name>
      <address>
        <city>Santiago De Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uppsala University</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orebro University Hospital</name>
      <address>
        <city>Örebro</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds General Infirmary</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Vascular Institute</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Thomas' London / Guy's Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>October 23, 2020</results_first_submitted>
  <results_first_submitted_qc>October 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2020</results_first_posted>
  <last_update_submitted>November 20, 2020</last_update_submitted>
  <last_update_submitted_qc>November 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CTAG</keyword>
  <keyword>TEVAR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03286400/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03286400/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CTAG Device With ACTIVE CONTROL</title>
          <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Scheduling difficulty</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CTAG Device With ACTIVE CONTROL</title>
          <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="127"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.1" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <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="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Netherlands</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Procedural Technical Success</title>
        <description>Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CTAG Device With ACTIVE CONTROL</title>
            <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Procedural Technical Success</title>
          <description>Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion</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="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Treatment Success at 30 Day Visit</title>
        <description>Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration</description>
        <time_frame>One month</time_frame>
        <population>Includes all subjects with treatment failure within 30 days as well as subjects with at least 15 days of follow-up. Subjects without a treatment failure within 30 days and with less than 15 days of follow-up were not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>CTAG Device With ACTIVE CONTROL</title>
            <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Treatment Success at 30 Day Visit</title>
          <description>Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration</description>
          <population>Includes all subjects with treatment failure within 30 days as well as subjects with at least 15 days of follow-up. Subjects without a treatment failure within 30 days and with less than 15 days of follow-up were not included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Freedom From Major Adverse Events at 30 Days</title>
        <description>Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss</description>
        <time_frame>30 Days</time_frame>
        <population>Includes all subjects with a Major Adverse Event within 30 days as well as subjects with at least 15 days of follow-up. Subjects without a Major Adverse Event within 30 days and with less than 15 days of follow-up were not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>CTAG Device With ACTIVE CONTROL</title>
            <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Freedom From Major Adverse Events at 30 Days</title>
          <description>Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss</description>
          <population>Includes all subjects with a Major Adverse Event within 30 days as well as subjects with at least 15 days of follow-up. Subjects without a Major Adverse Event within 30 days and with less than 15 days of follow-up were not included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Freedom From Major Adverse Events at 12 Months</title>
        <description>Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss</description>
        <time_frame>12 Months</time_frame>
        <population>Includes all subjects with a Major Adverse Event within 12 months as well as subjects with at least 275 days of follow-up. Subjects without a Major Adverse Event within 12 months and with less than 275 days of follow-up were not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>CTAG Device With ACTIVE CONTROL</title>
            <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Freedom From Major Adverse Events at 12 Months</title>
          <description>Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss</description>
          <population>Includes all subjects with a Major Adverse Event within 12 months as well as subjects with at least 275 days of follow-up. Subjects without a Major Adverse Event within 12 months and with less than 275 days of follow-up were not included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Treatment Success at 12 Month Visit</title>
        <description>Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration</description>
        <time_frame>One year</time_frame>
        <population>Includes all subjects with treatment failure within 12 months as well as subjects with at least 275 days of follow-up. Subjects without a treatment failure within 12 months and with less than 275 days of follow-up were not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>CTAG Device With ACTIVE CONTROL</title>
            <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Treatment Success at 12 Month Visit</title>
          <description>Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration</description>
          <population>Includes all subjects with treatment failure within 12 months as well as subjects with at least 275 days of follow-up. Subjects without a treatment failure within 12 months and with less than 275 days of follow-up were not included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events</title>
        <description>Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.</description>
        <time_frame>Days 30, 365, and 455</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CTAG Device With ACTIVE CONTROL</title>
            <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events</title>
          <description>Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.</description>
          <units>Probability</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.826" lower_limit="0.748" upper_limit="0.882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>365 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.699" lower_limit="0.609" upper_limit="0.772"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>455 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.628" lower_limit="0.487" upper_limit="0.740"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion</title>
        <description>One year change from first post-implant CT scan in maximum aortic diameter</description>
        <time_frame>One year</time_frame>
        <population>Includes all non-dissection subjects who have both post-procedure and 12-month measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>CTAG Device With ACTIVE CONTROL</title>
            <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion</title>
          <description>One year change from first post-implant CT scan in maximum aortic diameter</description>
          <population>Includes all non-dissection subjects who have both post-procedure and 12-month measurements.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&gt;= 5mm Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;= 5mm Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maximum False Lumen Diameter Among Dissection</title>
        <description>One year change from first post-implant CT scan in maximum false lumen diameter</description>
        <time_frame>One year</time_frame>
        <population>Includes all dissection subjects who have both post-procedure and 12-month measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>CTAG Device With ACTIVE CONTROL</title>
            <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maximum False Lumen Diameter Among Dissection</title>
          <description>One year change from first post-implant CT scan in maximum false lumen diameter</description>
          <population>Includes all dissection subjects who have both post-procedure and 12-month measurements.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&gt;= 5mm Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;= 5mm Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Minimum True Lumen Diameter Among Dissection</title>
        <description>One year change from first post-implant CT scan in minimum true lumen diameter</description>
        <time_frame>One year</time_frame>
        <population>Includes all dissection subjects who have both post-procedure and 12-month measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>CTAG Device With ACTIVE CONTROL</title>
            <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Minimum True Lumen Diameter Among Dissection</title>
          <description>One year change from first post-implant CT scan in minimum true lumen diameter</description>
          <population>Includes all dissection subjects who have both post-procedure and 12-month measurements.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&gt;= 5mm Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;= 5mm Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Maximum Aortic Diameter Among Dissection</title>
        <description>One year change from first post-implant CT scan in maximum aortic diameter</description>
        <time_frame>One year</time_frame>
        <population>Includes all dissection subjects who have both post-procedure and 12-month measurements.</population>
        <group_list>
          <group group_id="O1">
            <title>CTAG Device With ACTIVE CONTROL</title>
            <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maximum Aortic Diameter Among Dissection</title>
          <description>One year change from first post-implant CT scan in maximum aortic diameter</description>
          <population>Includes all dissection subjects who have both post-procedure and 12-month measurements.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&gt;= 5mm Decrease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;= 5mm Increase</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>455 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CTAG Device With ACTIVE CONTROL</title>
          <description>All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.&#xD;
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aorto-oesophageal fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Stent-graft endoleak</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Vascular stent occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infective aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anastomotic stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Incision site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Vascular access site pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Vascular graft haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Vascular procedure complication</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Pancreatogenous diabetes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hepatic cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Paraplegia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Spinal cord ischaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diaphragmatic disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Diaphragmatic paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Pulmonary air leakage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Aortic rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Iliac artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="127"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Eric Novak</name_or_title>
      <organization>W. L. Gore &amp; Associates</organization>
      <phone>314-440-2119</phone>
      <email>enovak@wlgore.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/NCT03286400
org study id: TAG 15-03
nct id: NCT03286400
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable
      Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the
      treatment of aortic disease as part of routine clinical practice.
This is an observational, prospective, single-arm, post-market registry designed to collect
      real-world clinical and device specific outcomes of the GORE® TAG® Conformable Thoracic Stent
      Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of
      aortic disease as part of routine clinical practice. A maximum of 20 clinical investigative
      sites in Europe will participate and up to 125 patients will be enrolled in this registry.
      All consecutive patients meeting protocol selection criteria, consented, with an intention to
      be treated with the CTAG Device with ACTIVE CONTROL will be included and followed through one
      year per institutional standard of care.
observational model: Cohort
time perspective: Prospective
measure: Number of Subjects With Procedural Technical Success
time frame: 24 hours
description: Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion
measure: Number of Subjects With Treatment Success at 30 Day Visit
time frame: One month
description: Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration
measure: Number of Subjects With Freedom From Major Adverse Events at 30 Days
time frame: 30 Days
description: Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss
measure: Number of Subjects With Freedom From Major Adverse Events at 12 Months
time frame: 12 Months
description: Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss
measure: Number of Subjects With Treatment Success at 12 Month Visit
time frame: One year
description: Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration
measure: Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events
time frame: Days 30, 365, and 455
description: Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.
measure: Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion
time frame: One year
description: One year change from first post-implant CT scan in maximum aortic diameter
measure: Change in Maximum False Lumen Diameter Among Dissection
time frame: One year
description: One year change from first post-implant CT scan in maximum false lumen diameter
measure: Change in Minimum True Lumen Diameter Among Dissection
time frame: One year
description: One year change from first post-implant CT scan in minimum true lumen diameter
measure: Change in Maximum Aortic Diameter Among Dissection
time frame: One year
description: One year change from first post-implant CT scan in maximum aortic diameter
arm group label: CTAG Device with ACTIVE CONTROL
description: All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
intervention type: Device
intervention name: CTAG Device with ACTIVE CONTROL
description: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
arm group label: CTAG Device with ACTIVE CONTROL
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giovanni Torsello, MD, PhD
role: Principal Investigator
affiliation: St Franziskus Hospital GmbH
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country: France
country: Germany
country: Italy
country: Netherlands
country: Spain
country: Sweden
country: United Kingdom
responsible party type: Sponsor
mesh term: Thoracic Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 