<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/NCT01710878</url>
  </required_header>
  <id_info>
    <org_study_id>HR07-001</org_study_id>
    <nct_id>NCT01710878</nct_id>
  </id_info>
  <brief_title>Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position</brief_title>
  <acronym>SYNERGY</acronym>
  <official_title>Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in Abdominal Position</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>
      Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and&#xD;
      occlusive disease of the abdominal aorta.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this multi center, single arm study is to demonstrate the safety and&#xD;
      performance of the Second Generation Anti-Microbial (InterGard Synergy) vascular graft in the&#xD;
      treatment of aneurismal and occlusive diseases of the abdominal aorta.&#xD;
&#xD;
      The primary endpoint is the assessment of primary and secondary graft patency. The secondary&#xD;
      endpoints were the assessment of adverse events and the assessment of triclosan and silver&#xD;
      contents in the serum over the time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2010</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>Primary Graft Patency</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary endpoint - assessment of AEs</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Follow-up timeframes - 1, 6, 12, 24, and 36 months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Secondary endpoint - levels of silver and triclosan</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Serum levels prior to surgery, 1 day post-implant, discharge and 30 days</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Abdominal Aorta Aneurysm</condition>
  <arm_group>
    <arm_group_label>Intergard Synergy Graft</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intergard Synergy Graft</intervention_name>
    <arm_group_label>Intergard Synergy Graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient aged 18-85 years&#xD;
&#xD;
        Patient presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or&#xD;
        aorto-iliac aneurysm and eligible for a revascularization with a bifurcated graft&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient treated as an emergency&#xD;
&#xD;
        Patient included in another investigation&#xD;
&#xD;
        Patient pregnant or lactating or woman of childbearing potential&#xD;
&#xD;
        Patient with a known allergy to the material device used (collagen, triclosan, silver)&#xD;
&#xD;
        Patient with previous aorto-iliac bypass or replacement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Baptiste Ricco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU La Milétrie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dupuytren</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital G. et R. Laennec</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU La Milétrie</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Nordwest</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 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/NCT01710878
org study id: HR07-001
nct id: NCT01710878
lead sponsor: 
has dmc: No
Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and
      occlusive disease of the abdominal aorta.
The purpose of this multi center, single arm study is to demonstrate the safety and
      performance of the Second Generation Anti-Microbial (InterGard Synergy) vascular graft in the
      treatment of aneurismal and occlusive diseases of the abdominal aorta.

      The primary endpoint is the assessment of primary and secondary graft patency. The secondary
      endpoints were the assessment of adverse events and the assessment of triclosan and silver
      contents in the serum over the time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Graft Patency
time frame: Up to 36 months
description: Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months
measure: Secondary endpoint - assessment of AEs
time frame: Up to 36 months
description: Follow-up timeframes - 1, 6, 12, 24, and 36 months
measure: Secondary endpoint - levels of silver and triclosan
time frame: Up to 30 days
description: Serum levels prior to surgery, 1 day post-implant, discharge and 30 days
arm group label: Intergard Synergy Graft
arm group type: Other
intervention type: Device
intervention name: Intergard Synergy Graft
arm group label: Intergard Synergy Graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jean-Baptiste Ricco, MD
role: Principal Investigator
affiliation: CHU La Milétrie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal