<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/NCT03295682</url>
  </required_header>
  <id_info>
    <org_study_id>CONNECT</org_study_id>
    <nct_id>NCT03295682</nct_id>
  </id_info>
  <brief_title>Registry in Patients With Thoracoabdominal Aneurysms</brief_title>
  <acronym>CONNECT</acronym>
  <official_title>Registry in Patients With Thoracoabdominal Aneurysms Treated With Multi-branch Stent Grafts Tailored to Their Individual Anatomies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JOTEC GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>JOTEC GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study patients will be observed, who receive a multi-branch stent graft tailored to&#xD;
      the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm&#xD;
      Crawford type I, II, III, IV or V.&#xD;
&#xD;
      The objective of this study is to evaluate clinical and technical success as well as safety&#xD;
      and feasibility of the multi-branch stent graft Systems used in endovascular treatment of&#xD;
      thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices.&#xD;
      Primary endpoint of this study is the rate of patients with stable or decreasing aneurysm&#xD;
      size at 12 months follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study patients will be observed, who receive a multi-branch stent graft tailored to&#xD;
      the patient´s anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm&#xD;
      Crawford type I, II, III, IV or V. Participating physicians will be asked to provide their&#xD;
      observations collected during routine care for patients he/she had decided to treat with a&#xD;
      multi-branch stent graft produced by JOTEC GmbH. Informed consent of the patients to allow&#xD;
      the use of their clinical records for the purpose of this observational study will be&#xD;
      obtained before data are being collected.&#xD;
&#xD;
      The period of data collection will be 36 months from the intervention for each patient. A&#xD;
      risk based source data verification will be performed. CT angiograms will be evaluated by a&#xD;
      CoreLab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>36 Months</target_duration>
  <primary_outcome>
    <measure>Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Decreasing size: &gt;/= 5mm Increasing size: &lt;/= 5mm compared to first post-operative CT angiogram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of all cause mortality</measure>
    <time_frame>intra-op, post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with aneurysm rupture</measure>
    <time_frame>post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related)</measure>
    <time_frame>post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of interventions in peri-operative periods (all related interventions until index procedure)</measure>
    <time_frame>intra-op</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of reinterventions</measure>
    <time_frame>post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with endoleaks type Ia, Ib, II, III, IV, V and of unknown origin</measure>
    <time_frame>post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with multi-branch stent graft migration</measure>
    <time_frame>post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with loss of device integrity</measure>
    <time_frame>post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with primary / secondary patency of branch vessels</measure>
    <time_frame>post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with stent graft infection</measure>
    <time_frame>post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with primary / secondary technical success</measure>
    <time_frame>post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with primary / secondary clinical success</measure>
    <time_frame>post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with removal or failure to implant the multi-branch stent graft</measure>
    <time_frame>intra-op, post-op until 36 months follow-up</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">47</enrollment>
  <condition>Thoracoabdominal Aneurysm</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endovascular thoracoabdominal aneurysm repair</intervention_name>
    <description>Endovascular treatment of patients with thoracoabdominal aneurysm using a multibranch stent graft tailored to the patient´s anatomy in combination with peripheral covered stents to bridge the visceral arteries</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total number of 40 male and female patients with asymptomatic thoracoabdominal aortic&#xD;
        aneurysm, treated with a multi-branch stent graft system.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Patients must have a thoracoabdominal aneurysm type Crawford type I, II, III, IV, or V&#xD;
&#xD;
          -  Patients must have a suitable proximal landing area&#xD;
&#xD;
          -  Patients must have a suitable distal landing area in the abdominal aorta or the iliac&#xD;
             arteries&#xD;
&#xD;
          -  Patients must have suitable access vessels&#xD;
&#xD;
          -  Patients must be available for the appropriate follow-up times for the duration of the&#xD;
             study&#xD;
&#xD;
          -  Patients have signed the informed consent before intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with infectious aneurysm&#xD;
&#xD;
          -  Patients with inflammatory aneurysm&#xD;
&#xD;
          -  Patients with ruptured or symptomatic aneurysm&#xD;
&#xD;
          -  Patients with traumatic aneurysm&#xD;
&#xD;
          -  Patients with aortic dissection&#xD;
&#xD;
          -  Patients who have a congenital degenerative collagen disease or connective tissue&#xD;
             disorder&#xD;
&#xD;
          -  Patients with thrombocytopenia&#xD;
&#xD;
          -  Patients with an eGFR &lt; 45ml/min/1.73m2 before the intervention&#xD;
&#xD;
          -  Patients with untreated hyperthyroidism&#xD;
&#xD;
          -  Patients with malignancy needing chemotherapy or radiation&#xD;
&#xD;
          -  Patients that will be treated or are treated with iliac branch devices&#xD;
&#xD;
          -  Patients pre-treated with Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard&#xD;
             Medical) stent grafts&#xD;
&#xD;
          -  Patients who are enrolled in another clinical study&#xD;
&#xD;
          -  Patients with life expectancy of less than 36 months&#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>Hubert Schelzig, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Uniklinikum Düsseldorf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uniklinikum Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <state>NRW</state>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>January 9, 2023</last_update_submitted>
  <last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03295682
org study id: CONNECT
nct id: NCT03295682
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study patients will be observed, who receive a multi-branch stent graft tailored to
      the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm
      Crawford type I, II, III, IV or V.

      The objective of this study is to evaluate clinical and technical success as well as safety
      and feasibility of the multi-branch stent graft Systems used in endovascular treatment of
      thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices.
      Primary endpoint of this study is the rate of patients with stable or decreasing aneurysm
      size at 12 months follow-up.
In this study patients will be observed, who receive a multi-branch stent graft tailored to
      the patient´s anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm
      Crawford type I, II, III, IV or V. Participating physicians will be asked to provide their
      observations collected during routine care for patients he/she had decided to treat with a
      multi-branch stent graft produced by JOTEC GmbH. Informed consent of the patients to allow
      the use of their clinical records for the purpose of this observational study will be
      obtained before data are being collected.

      The period of data collection will be 36 months from the intervention for each patient. A
      risk based source data verification will be performed. CT angiograms will be evaluated by a
      CoreLab.
observational model: Other
time perspective: Prospective
measure: Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)
time frame: 12 months follow-up
description: Decreasing size: >/= 5mm Increasing size: </= 5mm compared to first post-operative CT angiogram
measure: Rate of all cause mortality
time frame: intra-op, post-op until 36 months follow-up
measure: Rate of patients with aneurysm rupture
time frame: post-op until 36 months follow-up
measure: Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related)
time frame: post-op until 36 months follow-up
measure: Rate of interventions in peri-operative periods (all related interventions until index procedure)
time frame: intra-op
measure: Rate of reinterventions
time frame: post-op until 36 months follow-up
measure: Rate of patients with endoleaks type Ia, Ib, II, III, IV, V and of unknown origin
time frame: post-op until 36 months follow-up
measure: Rate of patients with multi-branch stent graft migration
time frame: post-op until 36 months follow-up
measure: Rate of patients with loss of device integrity
time frame: post-op until 36 months follow-up
measure: Rate of patients with primary / secondary patency of branch vessels
time frame: post-op until 36 months follow-up
measure: Rate of patients with stent graft infection
time frame: post-op until 36 months follow-up
measure: Rate of patients with primary / secondary technical success
time frame: post-op until 36 months follow-up
measure: Rate of patients with primary / secondary clinical success
time frame: post-op until 36 months follow-up
measure: Rate of patients with removal or failure to implant the multi-branch stent graft
time frame: intra-op, post-op until 36 months follow-up
intervention type: Device
intervention name: Endovascular thoracoabdominal aneurysm repair
description: Endovascular treatment of patients with thoracoabdominal aneurysm using a multibranch stent graft tailored to the patient´s anatomy in combination with peripheral covered stents to bridge the visceral arteries
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hubert Schelzig, Professor
role: Study Director
affiliation: Uniklinikum Düsseldorf
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Aneurysm