<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/NCT04429243</url>
  </required_header>
  <id_info>
    <org_study_id>JPS 19-05: AVR PMS</org_study_id>
    <nct_id>NCT04429243</nct_id>
  </id_info>
  <brief_title>GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study</brief_title>
  <official_title>GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>W.L.Gore &amp; Associates</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>W.L.Gore &amp; Associates</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will confirm the efficacy and safety in the clinical setting after the launch of&#xD;
      the GORE® VIABAHN® stent graft (hereafter referred to as &quot;Viabahn&quot;) for the treatment of&#xD;
      patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous&#xD;
      access graft.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Anticipated">July 6, 2023</completion_date>
  <primary_completion_date type="Actual">February 22, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Patency of Target Lesion</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Primary patency of target lesion is defined as the period during the patency was maintained from initial treatment until occlusion of target lesion or re-treatment of target lesion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Secondary patency of target lesion</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Secondary patency of target lesion is defined as the period during the patency was maintained from initial treatment (including the period of patency after re-treatment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Patency of Vascular Access Circuit</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Primary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until occlusion in vascular access or re-treatment in vascular access circuit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Secondary Patency of Vascular Access Circuit</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Secondary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until discontinuation of the use of vascular access circuit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Cumulative Number of Re-treatment in Target Lesion</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Mean cumulative number of re-treatment in target lesion is defined as the number of re-treatment performed for target lesion after the initial treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Achieving Technical Success</measure>
    <time_frame>Day 1</time_frame>
    <description>Technical Success is defined as &lt; 30% residual stenosis after initial treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Achieving Clinical Success</measure>
    <time_frame>Day 1 to Month 1 follow up</time_frame>
    <description>Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Experiencing Adverse Events</measure>
    <time_frame>Day 1 to Month 1 follow up</time_frame>
    <description>An adverse event (AE) is defined as any unfavorable or unintended sign (including abnormal laboratory changes), symptom, or illness associated with the use of a medical device. Unless worsening of severity or increasing of incidence during the surveillance, the primary disease of the patient is not considered an adverse event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Experiencing Device Defects</measure>
    <time_frame>Day 1 to Month 1 follow up</time_frame>
    <description>A device defect is defined as a defect such as damage, malfunction, etc. that are widely unfavorable. Regardless of whether they are due to design, marketing, distribution, or use.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">124</enrollment>
  <condition>Vascular Stent-Graft Stenosis</condition>
  <arm_group>
    <arm_group_label>GORE® VIABAHN® Stent Graft</arm_group_label>
    <description>Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GORE® VIABAHN® Stent Graft</intervention_name>
    <description>On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.</description>
    <arm_group_label>GORE® VIABAHN® Stent Graft</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous&#xD;
        (AV) access graft in Japan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who developed stenosis or occlusion at the venous anastomosis of&#xD;
             synthetic arteriovenous access graft&#xD;
&#xD;
          -  Participants who was used to repair vascular access circuits for purposes other than&#xD;
             treatment of stenosis or occlusion at the venous anastomosis of synthetic&#xD;
             arteriovenous access graft&#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>Kei Kaneko</last_name>
    <role>Study Director</role>
    <affiliation>W. L. Gore &amp; Associates G.K</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaikoukai Central Clinic</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>454-0933</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya Vascular Access Clinic</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>464-0850</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matsuyama Red Cross Hospital</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <zip>790-8524</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Rosai Hospital</name>
      <address>
        <city>Amagasaki</city>
        <state>Hyogo</state>
        <zip>660-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa Cardiovascular Hospital</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-0007</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama Dai-ichi Hospital</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>220-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Kumamoto Hospital</name>
      <address>
        <city>Higashi</city>
        <state>Kumamoto</state>
        <zip>861-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical Center</name>
      <address>
        <city>Kawagoe</city>
        <state>Saitama</state>
        <zip>350-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka General Hospital</name>
      <address>
        <city>Aoi</city>
        <state>Shizuoka</state>
        <zip>420-8527</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bouseidai1 Clinic</name>
      <address>
        <city>Numazu</city>
        <state>Shizuoka</state>
        <zip>410-0043</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haruguchi Vascular Access Clinic</name>
      <address>
        <city>Chiyoda</city>
        <state>Tokyo</state>
        <zip>102-0072</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kichijoji Asahi Hospital</name>
      <address>
        <city>Musashino</city>
        <state>Tokyo</state>
        <zip>180-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular Access Clinic Mejiro</name>
      <address>
        <city>Toshima</city>
        <state>Tokyo</state>
        <zip>171-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Yamanashi Hospital</name>
      <address>
        <city>Chuo</city>
        <state>Yamanashi</state>
        <zip>409-3898</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka City Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-0046</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ikeda Vascular Access, Dialysis and Internal Medicine Clinic</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Vascular Access Temma Nakamura Clinic</name>
      <address>
        <city>Osaka</city>
        <zip>530-6012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</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>Constriction, Pathologic</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/NCT04429243
org study id: JPS 19-05: AVR PMS
nct id: NCT04429243
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study will confirm the efficacy and safety in the clinical setting after the launch of
      the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of
      patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous
      access graft.
observational model: Case-Only
time perspective: Prospective
measure: Primary Patency of Target Lesion
time frame: up to 2 years
description: Primary patency of target lesion is defined as the period during the patency was maintained from initial treatment until occlusion of target lesion or re-treatment of target lesion.
measure: Secondary patency of target lesion
time frame: up to 2 years
description: Secondary patency of target lesion is defined as the period during the patency was maintained from initial treatment (including the period of patency after re-treatment).
measure: Primary Patency of Vascular Access Circuit
time frame: up to 2 years
description: Primary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until occlusion in vascular access or re-treatment in vascular access circuit.
measure: Secondary Patency of Vascular Access Circuit
time frame: up to 2 years
description: Secondary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until discontinuation of the use of vascular access circuit.
measure: Mean Cumulative Number of Re-treatment in Target Lesion
time frame: up to 2 years
description: Mean cumulative number of re-treatment in target lesion is defined as the number of re-treatment performed for target lesion after the initial treatment.
measure: Number of Subjects Achieving Technical Success
time frame: Day 1
description: Technical Success is defined as < 30% residual stenosis after initial treatment.
measure: Number of Subjects Achieving Clinical Success
time frame: Day 1 to Month 1 follow up
description: Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.
measure: Number of Subjects Experiencing Adverse Events
time frame: Day 1 to Month 1 follow up
description: An adverse event (AE) is defined as any unfavorable or unintended sign (including abnormal laboratory changes), symptom, or illness associated with the use of a medical device. Unless worsening of severity or increasing of incidence during the surveillance, the primary disease of the patient is not considered an adverse event.
measure: Number of Subjects Experiencing Device Defects
time frame: Day 1 to Month 1 follow up
description: A device defect is defined as a defect such as damage, malfunction, etc. that are widely unfavorable. Regardless of whether they are due to design, marketing, distribution, or use.
arm group label: GORE® VIABAHN® Stent Graft
description: Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation.
intervention type: Device
intervention name: GORE® VIABAHN® Stent Graft
description: On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.
arm group label: GORE® VIABAHN® Stent Graft
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kei Kaneko
role: Study Director
affiliation: W. L. Gore & Associates G.K
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Constriction, Pathologic