<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/NCT04430114</url>
  </required_header>
  <id_info>
    <org_study_id>CLEOPATRA study</org_study_id>
    <nct_id>NCT04430114</nct_id>
  </id_info>
  <brief_title>MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms</brief_title>
  <official_title>DediCated MuLtibranchEd DacrOn Graft for OPen RepAir of ThoRacoabdominal Aneurysms - CLEOPATRA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS San Raffaele</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is the evaluation of the technical success and clinical outcomes&#xD;
      of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec &quot;TAAA spinal&#xD;
      loop graft&quot; &quot;custom made &quot;CE equivalent&quot; branched prosthesis, compared with the patient&#xD;
      cohort already treated with standard and / or bench-top prostheses Gelweave ™ Coselli&#xD;
      Thoracoabdominal Grafts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of participants who obtain technical success</measure>
    <time_frame>12 month</time_frame>
    <description>number of surviving participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries</measure>
    <time_frame>12 month</time_frame>
    <description>freedom from thrombosis of the prosthetic branches,visceral arteries and replanted intercostal arteries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of aneurysmal dilatation of visceral and replanted intercostal arteries</measure>
    <time_frame>12 month</time_frame>
    <description>freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Aneurysm Abdominal</condition>
  <condition>Aneurysm Thoracic</condition>
  <arm_group>
    <arm_group_label>TAAA spinal loop graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms</intervention_name>
    <description>Jotec &quot;TAAA spinal loop graft&quot; &quot;custom made CE equivalent&quot; branched prosthesis, compared with the cohort of patients already treated with standard prostheses and / or Gelweave ™ Coselli Thoracoabdominal Grafts.</description>
    <arm_group_label>TAAA spinal loop graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged ≥ 18 years;&#xD;
&#xD;
          -  patients candidates for surgical treatment of thoraco-abdominal aorta of the II and&#xD;
             III type sec. Crawford using &quot;TAAA spinal loop graft&quot; &quot;custom made CE equivalent&quot;&#xD;
             prosthesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • patients aged ≤ 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>San Raffaele Hospital</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS San Raffaele</investigator_affiliation>
    <investigator_full_name>Bertoglio Luca</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
    <mesh_term>Aortic Aneurysm, Thoracic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04430114
org study id: CLEOPATRA study
nct id: NCT04430114
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is the evaluation of the technical success and clinical outcomes
      of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec "TAAA spinal
      loop graft" "custom made "CE equivalent" branched prosthesis, compared with the patient
      cohort already treated with standard and / or bench-top prostheses Gelweave ™ Coselli
      Thoracoabdominal Grafts.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: number of participants who obtain technical success
time frame: 12 month
description: number of surviving participants
measure: incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries
time frame: 12 month
description: freedom from thrombosis of the prosthetic branches,visceral arteries and replanted intercostal arteries
measure: incidence of aneurysmal dilatation of visceral and replanted intercostal arteries
time frame: 12 month
description: freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries
arm group label: TAAA spinal loop graft
arm group type: Experimental
intervention type: Device
intervention name: branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms
description: Jotec "TAAA spinal loop graft" "custom made CE equivalent" branched prosthesis, compared with the cohort of patients already treated with standard prostheses and / or Gelweave ™ Coselli Thoracoabdominal Grafts.
arm group label: TAAA spinal loop graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS San Raffaele
investigator full name: Bertoglio Luca
investigator title: Principal Investigator
mesh term: Aneurysm
mesh term: Aortic Aneurysm, Abdominal
mesh term: Aortic Aneurysm, Thoracic
sharing ipd: Undecided