<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/NCT03828253</url>
  </required_header>
  <id_info>
    <org_study_id>pAVF 1.0</org_study_id>
    <nct_id>NCT03828253</nct_id>
  </id_info>
  <brief_title>Ellipsys Fistula for Hemodialysis Access</brief_title>
  <official_title>Ellipsys Percutaneous Arteriovenous Fistula for Hemodialysis Access</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Richmond Vascular Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Richmond Vascular Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To report the outcomes of patients having percutaneous proximal radial artery fistula&#xD;
      creation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study would like to enroll up to 100 patients without age, gender-based, race and&#xD;
      ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing&#xD;
      potential are not excluded. If a pregnant patient required, an arteriovenous fistula for&#xD;
      hemodialysis an Ellipsys® fistula would be an option. The Investigator would like to consent&#xD;
      previous Ellipsys® patients with appropriate medical records so that the Investigator may&#xD;
      capture participants data for outcomes reporting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 27, 2018</start_date>
  <completion_date type="Anticipated">August 27, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 27, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Blood flow Volume</measure>
    <time_frame>90 days</time_frame>
    <description>Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>ESRD</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Recruitment of subjects will be from the current End Stage Renal disease patient population&#xD;
        at Richmond Vascular Center and referrals from Nephrologists and Vascular Surgeons.&#xD;
&#xD;
        The study would like to enroll up to 100 patients without age, gender-based, race and&#xD;
        ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing&#xD;
        potential are not excluded. If a pregnant patient required, an arteriovenous fistula for&#xD;
        hemodialysis an Ellipsys® fistula would be an option. We would like to consent previous&#xD;
        Ellipsys® patients with appropriate medical records so that we may capture their data for&#xD;
        outcomes reporting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient age &gt; 18 years or older&#xD;
&#xD;
          -  Diagnosed with ESRD or chronic kidney disease requiring dialysis or anticipating start&#xD;
             of dialysis&#xD;
&#xD;
          -  Adjacent vein diameter of &gt; 2.0 mm at target anastomosis site and confirmed clinically&#xD;
             significant outflow&#xD;
&#xD;
          -  Arterial lumen diameter of &gt; 2.0 mm at target anastomosis site&#xD;
&#xD;
          -  Adequate collateral arterial perfusion: Barbeau test grade A through C&#xD;
&#xD;
          -  Radial artery -adjacent vein proximity &lt; 1.5 mm measured lumen edge-to-lumen edge via&#xD;
             ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Target vessel that are &lt; 2mm is diameter&#xD;
&#xD;
          -  Distance between the target artery and vein &gt; 1.5 mm&#xD;
&#xD;
          -  Edema of the upper extremity on the ipsilateral side&#xD;
&#xD;
          -  Barbeau test grade D&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Hull, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Richmond Vascular Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tricia Eichenlaub, RN</last_name>
    <phone>804-864-8346</phone>
    <email>Teichenlaub@Richmondvascularcenter.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Brittani Lewis</last_name>
    <phone>804-864-8346</phone>
    <email>Blewis@Richmondvascularcenter.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Richmond Vascular Center</name>
      <address>
        <city>North Chesterfield</city>
        <state>Virginia</state>
        <zip>23236</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tricia Eichenlaub, RN</last_name>
      <phone>804-864-8346</phone>
      <email>Teichenlaub@richmondvascularcenter.com</email>
    </contact>
    <contact_backup>
      <last_name>Brittani Lewis</last_name>
      <phone>804-864-8346</phone>
      <email>Blewis@Richmondvascularcenter.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jeffrey Hull, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</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>Fistula</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/NCT03828253
org study id: pAVF 1.0
nct id: NCT03828253
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To report the outcomes of patients having percutaneous proximal radial artery fistula
      creation.
The study would like to enroll up to 100 patients without age, gender-based, race and
      ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing
      potential are not excluded. If a pregnant patient required, an arteriovenous fistula for
      hemodialysis an Ellipsys® fistula would be an option. The Investigator would like to consent
      previous Ellipsys® patients with appropriate medical records so that the Investigator may
      capture participants data for outcomes reporting.
observational model: Cohort
time perspective: Prospective
measure: Blood flow Volume
time frame: 90 days
description: Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Jeffrey Hull, MD
role: Principal Investigator
affiliation: Richmond Vascular Center
last name: Tricia Eichenlaub, RN
phone: 804-864-8346
email: Teichenlaub@Richmondvascularcenter.com
last name: Brittani Lewis
phone: 804-864-8346
email: Blewis@Richmondvascularcenter.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Fistula