xml: <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/NCT05969782</url>
    </required_header>
    <id_info>
      <org_study_id>32380920.5.0000.5463</org_study_id>
      <nct_id>NCT05969782</nct_id>
    </id_info>
    <brief_title>The Enzen Trial: Comparison of Evar Endoprosthesis: Endurant Versus Zenith</brief_title>
    <acronym>ENZEN</acronym>
    <official_title>The Enzen Trial: Comparison of EVAR Outcomes With Endurant Versus Zenith Endoprosthesis: a Prospective Analysis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital do Servidor Publico Estadual</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital do Servidor Publico Estadual</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym&#xD;
        using Endurant II (Medtronic) or Zenith (Cook).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym&#xD;
        using Endurant II (Medtronic) or Zenith (Cook).&#xD;
  &#xD;
        The patients will be evaluated in a follow-up, regarding overall mortality rate,&#xD;
        perioperative mortality rate and outcomes, such as Endoleaks and reinterventions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Perioperative Mortality rate</measure>
      <time_frame>30 days</time_frame>
      <description>Mortality rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reinterventions</measure>
      <time_frame>2 years</time_frame>
      <description>Reinterventions during follow-up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Endoleaks</measure>
      <time_frame>2 years</time_frame>
      <description>Endoleaks during follow-up</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Aortic Aneurysm</condition>
    <condition>Aortoiliac Atherosclerosis</condition>
    <arm_group>
      <arm_group_label>Endurant II</arm_group_label>
      <description>Patients with aortoiliac aneurysm submitted to EVAR with Endurant II.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Zenith</arm_group_label>
      <description>Patients with aortoiliac aneurysm submitted to EVAR with Zenith.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EVAR</intervention_name>
      <description>Endovascular repair of aortoiliac aneurysm using Zenith or Endurant</description>
      <arm_group_label>Endurant II</arm_group_label>
      <arm_group_label>Zenith</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          PAtiens with infra-renal aortoiliac aneurysms submitted to EVAR.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria: Aortoiliac infra-renal aneurysms.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria: Thoracoabdominal aortic aneurysms, pararenal and supra-renal aortic&#xD;
          aneurysms&#xD;
  &#xD;
            -  Patients not suitable for EVAR.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hospital do Servidor Público Estadual de São Paulo</name>
        <address>
          <city>São Paulo</city>
          <state>SP</state>
          <zip>04028-000</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital do Servidor Publico Estadual</investigator_affiliation>
      <investigator_full_name>Rafael de Athayde Soares</investigator_full_name>
      <investigator_title>MD; PhD</investigator_title>
    </responsible_party>
    <keyword>aneurysm</keyword>
    <keyword>aortic</keyword>
    <keyword>aortic disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aneurysm</mesh_term>
      <mesh_term>Atherosclerosis</mesh_term>
      <mesh_term>Aortic Aneurysm</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969782
  org study id: 32380920.5.0000.5463
  nct id: NCT05969782
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym
        using Endurant II (Medtronic) or Zenith (Cook).
  A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym
        using Endurant II (Medtronic) or Zenith (Cook).
  
        The patients will be evaluated in a follow-up, regarding overall mortality rate,
        perioperative mortality rate and outcomes, such as Endoleaks and reinterventions.
  observational model: Cohort
  time perspective: Prospective
  measure: Perioperative Mortality rate
  time frame: 30 days
  description: Mortality rate
  measure: Reinterventions
  time frame: 2 years
  description: Reinterventions during follow-up
  measure: Endoleaks
  time frame: 2 years
  description: Endoleaks during follow-up
  arm group label: Endurant II
  description: Patients with aortoiliac aneurysm submitted to EVAR with Endurant II.
  arm group label: Zenith
  description: Patients with aortoiliac aneurysm submitted to EVAR with Zenith.
  intervention type: Device
  intervention name: EVAR
  description: Endovascular repair of aortoiliac aneurysm using Zenith or Endurant
  arm group label: Endurant II
  arm group label: Zenith
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: Hospital do Servidor Publico Estadual
  investigator full name: Rafael de Athayde Soares
  investigator title: MD; PhD
  mesh term: Aneurysm
  mesh term: Atherosclerosis
  mesh term: Aortic Aneurysm
  sharing ipd: No