<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/NCT01663064</url>
  </required_header>
  <id_info>
    <org_study_id>11-018</org_study_id>
    <nct_id>NCT01663064</nct_id>
  </id_info>
  <brief_title>Zenith® p-Branch™: Single-Center Study</brief_title>
  <acronym>PBCT</acronym>
  <official_title>Zenith® p-Branch™: Single-Center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cook Group Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cook Group Incorporated</source>
  <brief_summary>
    <textblock>
      The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory&#xD;
      Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of&#xD;
      abdominal aortic aneurysms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">March 16, 2020</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical Success</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Aortic Aneurysm</condition>
  <condition>Abdominal Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>Endovascular</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endovascular treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endovascular treatment (Zenith® p-Branch™ endovascular graft)</intervention_name>
    <description>Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.</description>
    <arm_group_label>Endovascular</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pararenal or juxtarenal AAA &gt;5.0 cm in diameter&#xD;
&#xD;
          -  Pararenal or juxtarenal AAA with history of growth &gt;0.5 cm/year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Life expectancy &lt; 2 years&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Inability or refusal to give informed consent by the patient or a legally authorized&#xD;
             representative&#xD;
&#xD;
          -  Unwilling or unable to comply with the follow-up schedule&#xD;
&#xD;
          -  Additional medical restrictions as specified in the Clinical Investigation Plan&#xD;
&#xD;
          -  Additional anatomical restrictions as specified in the Clinical Investigation Plan&#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>Timothy A. Resch, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skane University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skane University Hospital</name>
      <address>
        <city>Malmo</city>
        <zip>SE-205 02</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Abdominal aortic aneurysm</keyword>
  <keyword>Endovascular</keyword>
  <keyword>Fenestration</keyword>
  <keyword>Juxtarenal</keyword>
  <keyword>Off-the-shelf</keyword>
  <keyword>Pararenal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</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/NCT01663064
org study id: 11-018
nct id: NCT01663064
lead sponsor: 
The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory
      Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of
      abdominal aortic aneurysms.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical Success
time frame: Up to 5 years
description: Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography.
arm group label: Endovascular
arm group type: Experimental
description: Endovascular treatment
intervention type: Device
intervention name: Endovascular treatment (Zenith® p-Branch™ endovascular graft)
description: Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
arm group label: Endovascular
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Timothy A. Resch, MD, PhD
role: Principal Investigator
affiliation: Skane University Hospital
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal