<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/NCT01698671</url>
  </required_header>
  <id_info>
    <org_study_id>MCV00010173</org_study_id>
    <nct_id>NCT01698671</nct_id>
  </id_info>
  <brief_title>InterGard Synergy Post-Marketing Surveillance Study</brief_title>
  <official_title>InterGard Synergy Post-Marketing Surveillance Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maquet Cardiovascular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maquet Cardiovascular</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess the performance and safety of the InterGard Synergy&#xD;
      vascular graft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta&#xD;
      and peripheral arteries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Graft Patency and Complications</measure>
    <time_frame>6 months</time_frame>
    <description>Patency will be assessed by color-coded duplex ultrasound up to 6 months post implantation.&#xD;
Complications including the occurrence of graft infections will be assessed up to post implantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>6 months</time_frame>
    <description>Mortality rate will be assessed up to 6 months post implantation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Aortic Aneurysm, Abdominal</condition>
  <condition>Occlusive Disease of Artery of Lower Extremity</condition>
  <arm_group>
    <arm_group_label>InterGard Synergy Vascular Graft</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InterGard Synergy Vascular Graft</intervention_name>
    <arm_group_label>InterGard Synergy Vascular Graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients requiring an InterGard Synergy Vascular Graft&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with contra-indications per InterGard Synergy Vascular Graft&#xD;
&#xD;
          -  Patients with current graft infection&#xD;
&#xD;
          -  Patients with a known allergy to collagen, triclosan or silver acetate&#xD;
&#xD;
          -  Patients who require urgent or emergent surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Max Zegelman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Krankenhaus Nordwest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Study Centers</name>
      <address>
        <city>Graz, Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Centers</name>
      <address>
        <city>Frankfurt, Karlsruhe</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Centers</name>
      <address>
        <city>Heidelberg, Hamburg, Hanau</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>November 24, 2013</last_update_submitted>
  <last_update_submitted_qc>November 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 26, 2013</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>
    <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/NCT01698671
org study id: MCV00010173
nct id: NCT01698671
lead sponsor: 
has dmc: No
The purpose of the study is to assess the performance and safety of the InterGard Synergy
      vascular graft.
Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta
      and peripheral arteries.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Graft Patency and Complications
time frame: 6 months
description: Patency will be assessed by color-coded duplex ultrasound up to 6 months post implantation.
Complications including the occurrence of graft infections will be assessed up to post implantation.
measure: Mortality rate
time frame: 6 months
description: Mortality rate will be assessed up to 6 months post implantation.
arm group label: InterGard Synergy Vascular Graft
arm group type: Other
intervention type: Device
intervention name: InterGard Synergy Vascular Graft
arm group label: InterGard Synergy Vascular Graft
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Max Zegelman, MD
role: Principal Investigator
affiliation: Krankenhaus Nordwest
facility: 
facility: 
facility: 
country: Austria
country: Germany
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal