<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/NCT02254356</url>
  </required_header>
  <id_info>
    <org_study_id>12-005-FLX</org_study_id>
    <nct_id>NCT02254356</nct_id>
  </id_info>
  <brief_title>Zilver Flex Post-Market Study in Japan</brief_title>
  <official_title>Zilver PTX Post-Market Surveillance Study of Bare Metal Stents for Treating Femoropopliteal Artery Disease in Japan</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>
      Japanese post market clinical study of the Zilver Flex device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">December 26, 2017</completion_date>
  <primary_completion_date type="Actual">December 26, 2017</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>Occurrence of stent fracture</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of adverse events</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">239</enrollment>
  <condition>Peripheral Arterial Disease (PAD)</condition>
  <arm_group>
    <arm_group_label>Zilver</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zilver Flex Bare Metal Stent</intervention_name>
    <arm_group_label>Zilver</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic peripheral arterial disease (PAD) involving the above-the-knee&#xD;
             femoropopliteal arteries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Michael D Dake, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fukuoka Sanno Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>814-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>March 29, 2018</last_update_submitted>
  <last_update_submitted_qc>March 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>drug-eluting stent, paclitaxel-eluting stent, peripheral artery disease, peripheral vascular disease, superficial femoral artery, popliteal artery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</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/NCT02254356
org study id: 12-005-FLX
nct id: NCT02254356
lead sponsor: 
Japanese post market clinical study of the Zilver Flex device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of stent fracture
time frame: 3 years
measure: Rate of adverse events
time frame: 3 years
arm group label: Zilver
arm group type: Experimental
intervention type: Device
intervention name: Zilver Flex Bare Metal Stent
arm group label: Zilver
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Michael D Dake, MD
role: Principal Investigator
affiliation: Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases