<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/NCT01663051</url>
  </required_header>
  <id_info>
    <org_study_id>10-018</org_study_id>
    <nct_id>NCT01663051</nct_id>
  </id_info>
  <brief_title>Evaluation of the Zilver® Vena™ Venous Stent</brief_title>
  <acronym>VIVO EU</acronym>
  <official_title>Evaluation of the Zilver® Vena™ Venous Stent</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>
      This prospective, non-randomized, multi-center study is intended to evaluate the Zilver®&#xD;
      Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Major Adverse Events</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Patency</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed via ultrasound</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Iliofemoral Venous Outflow Obstruction</condition>
  <arm_group>
    <arm_group_label>Stent</arm_group_label>
    <description>Stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zilver Vena Venous Stent</intervention_name>
    <description>Stenting iliofemoral venous outflow obstruction</description>
    <arm_group_label>Stent</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with symptomatic iliofemoral venous outflow obstruction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic venous outflow obstruction in up to two iliofemoral venous segments (one&#xD;
             in each limb), demonstrated by:&#xD;
&#xD;
          -  CEAP 'C' ≥ 3, or&#xD;
&#xD;
          -  VCSS pain score ≥ 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  Pregnant or planning to become pregnant in the next 12 months&#xD;
&#xD;
          -  Planned surgical or interventional procedures (except thrombolysis and thrombectomy in&#xD;
             preparation for the procedure or vena cava filter placement prior to stent&#xD;
             implantation in patients at high risk for pulmonary embolism) within 30 days prior to&#xD;
             or after the study procedure.&#xD;
&#xD;
          -  Lesions with intended treatment lengths extending into the inferior vena cava or below&#xD;
             the level of the lesser trochanter&#xD;
&#xD;
          -  Previous stenting of the target vessel&#xD;
&#xD;
          -  Iliofemoral venous segment unsuitable for treatment with available sizes of study&#xD;
             devices&#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>Klinikum Arnsberg GmbH</name>
      <address>
        <city>Arnsberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galway University Hospitals</name>
      <address>
        <city>Galway</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Madrid Monteprincipe</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Winterthur</name>
      <address>
        <city>Winterthur</city>
        <zip>8401</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Denmark</country>
  </removed_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>October 31, 2016</last_update_submitted>
  <last_update_submitted_qc>October 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01663051
org study id: 10-018
nct id: NCT01663051
lead sponsor: 
This prospective, non-randomized, multi-center study is intended to evaluate the Zilver®
      Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
observational model: Cohort
time perspective: Prospective
measure: Major Adverse Events
time frame: 1 month
measure: Patency
time frame: 12 months
description: Assessed via ultrasound
arm group label: Stent
description: Stent
intervention type: Device
intervention name: Zilver Vena Venous Stent
description: Stenting iliofemoral venous outflow obstruction
arm group label: Stent
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Ireland
country: Spain
country: Switzerland
country: United Kingdom
country: Denmark
responsible party type: Sponsor