<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/NCT03300024</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00069002</org_study_id>
    <nct_id>NCT03300024</nct_id>
  </id_info>
  <brief_title>Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access</brief_title>
  <official_title>A Prospective Randomized Study of Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</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>
      The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic&#xD;
      grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arteriovenous grafts (AVG) remain reliable substitutes for permanent hemodialysis access in&#xD;
      scenarios that preclude the placement of arteriovenous fistulae. There is scarcity of&#xD;
      evidence to support the current preference of synthetic conduits over biologic grafts in&#xD;
      clinical practice. Advances in the design of AVG's warrant contemporary comparisons between&#xD;
      synthetic and biologic AVG options. This is especially important as biologic conduits may&#xD;
      confer an advantage by virtue of their inherent similarity to the native human vasculature.&#xD;
&#xD;
      The overall goal of this project is to compare one and two year patency (functional, primary,&#xD;
      primary assisted and secondary), complication rates and re-intervention rates between BCA and&#xD;
      standard ePTFE grafts. The investigators hypothesize that vascular patient who will receive&#xD;
      the BCA graft will have improved patency as well as lower complication and re-intervention&#xD;
      rates compared to the standard ePTFE graft.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding ended&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2015</start_date>
  <completion_date type="Actual">February 12, 2018</completion_date>
  <primary_completion_date type="Actual">February 12, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will undergo surgery as per standard of care and receive the randomized graft in compliance to National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Arteriovenous graft creation. Surgeries will be elective in nature. The grafts will be placed either in the arm (brachial artery-axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) based on anatomic suitability</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The study will not be blinded because patient side blinding is expected to have minimal to no effect, while physician side blinding is impractical; and difficult to achieve due to the primary surgeon being the one usually who follows up on any intervention or treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients With Primary Graft Patency</measure>
    <time_frame>One year after Graft Placement</time_frame>
    <description>Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Primary-Assisted Graft Patency</measure>
    <time_frame>One year after Graft Placement</time_frame>
    <description>Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Secondary Graft Patency</measure>
    <time_frame>One year after Graft Placement</time_frame>
    <description>Secondary patency is defined as the interval from graft placement to graft failure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Functional Patency</measure>
    <time_frame>One year after Graft Placement</time_frame>
    <description>Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Primary Graft Patency</measure>
    <time_frame>Two years after Graft Placement</time_frame>
    <description>Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Primary-Assisted Graft Patency</measure>
    <time_frame>Two years after Graft Placement</time_frame>
    <description>Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Secondary Graft Patency</measure>
    <time_frame>Two years after Graft Placement</time_frame>
    <description>Secondary patency is defined as the interval from graft placement to graft failure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Functional Patency</measure>
    <time_frame>Two years after Graft Placement</time_frame>
    <description>Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Pseudoaneurysms Formation at the Access Site</measure>
    <time_frame>At 6 months after Graft Placement</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Pseudoaneurysms Formation at the Access Site</measure>
    <time_frame>At 12 months after Graft Placement</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Pseudoaneurysms Formation at the Access Site</measure>
    <time_frame>At 18 months after Graft Placement</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Pseudoaneurysms Formation at the Access Site</measure>
    <time_frame>At 24 months after Graft Placement</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Surgical Site Infection</measure>
    <time_frame>At 6 months after Graft Placement</time_frame>
    <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Surgical Site Infection</measure>
    <time_frame>At 12 months after Graft Placement</time_frame>
    <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Surgical Site Infection</measure>
    <time_frame>At 18 months after Graft Placement</time_frame>
    <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Surgical Site Infection</measure>
    <time_frame>At 24 months after Graft Placement</time_frame>
    <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steal Syndrome</measure>
    <time_frame>At 6 months after Graft Placement</time_frame>
    <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steal Syndrome</measure>
    <time_frame>At 12 months after Graft Placement</time_frame>
    <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steal Syndrome</measure>
    <time_frame>At 18 months after Graft Placement</time_frame>
    <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Steal Syndrome</measure>
    <time_frame>At 24 months after Graft Placement</time_frame>
    <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</measure>
    <time_frame>At 6 months after Graft Placement</time_frame>
    <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</measure>
    <time_frame>At 12 months after Graft Placement</time_frame>
    <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</measure>
    <time_frame>At 18 months after Graft Placement</time_frame>
    <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</measure>
    <time_frame>At 24 months after Graft Placement</time_frame>
    <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>End Stage Renal Disease</condition>
  <condition>Hemolysis</condition>
  <condition>Arteriovenous Graft</condition>
  <arm_group>
    <arm_group_label>Expanded polytetrafluoroethylene (ePTFE)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bovine carotid Artery Graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Expanded polytetrafluoroethylene Graft</intervention_name>
    <description>Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
    <arm_group_label>Expanded polytetrafluoroethylene (ePTFE)</arm_group_label>
    <other_name>Synthetic Graft</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bovine Carotid Artery Graft</intervention_name>
    <description>Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
    <arm_group_label>Bovine carotid Artery Graft</arm_group_label>
    <other_name>Biological Graft</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at least 18 years of age&#xD;
&#xD;
          -  Have End Stage Renal Disease and are undergoing Arterio-Venous-Graft surgery&#xD;
&#xD;
          -  Not Eligible to receive an Arterio-Venous-Fistula&#xD;
&#xD;
          -  Provided written informed consent&#xD;
&#xD;
          -  Agreed to return for all required clinical follow up for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Eligible to receive an Arterio-Venous-Fistula&#xD;
&#xD;
          -  Known allergic reaction or history of intolerance to any ePTFE or BCA components&#xD;
&#xD;
          -  Local infection at AVG placement site at the time of surgery&#xD;
&#xD;
          -  Patients with a bleeding disorder or who refuse blood transfusion&#xD;
&#xD;
          -  Patients with an active malignancy&#xD;
&#xD;
          -  Life expectancy less than 1 year&#xD;
&#xD;
          -  Pregnant women or those planning on becoming pregnant for the duration of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Reifsnyder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <results_first_submitted>March 29, 2019</results_first_submitted>
  <results_first_submitted_qc>April 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 14, 2019</results_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemodialysis</keyword>
  <keyword>Arteriovenous</keyword>
  <keyword>Graft</keyword>
  <keyword>polytetrafluoroethylene</keyword>
  <keyword>Bovine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Hemolysis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only key study personnel will be responsible for entering and tracking information. At the end of the study period, study coordinators and research fellows will have access to the final trial dataset and will analyse the data. The final results will be communicated to the PI and co-PI's, the sponsors and participants and will be later published in a peer-reviewed scientific journal.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 15, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03300024/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 27, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03300024/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
          <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion.&#xD;
Expanded polytetrafluoroethylene Graft: Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery t</description>
        </group>
        <group group_id="P2">
          <title>Bovine Carotid Artery Graft</title>
          <description>The bovine carotid artery (BCA) biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Work on this project was discontinued. Baseline data for &quot;Race and Ethnicity&quot; was not collected.</population>
      <group_list>
        <group group_id="B1">
          <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
          <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion.&#xD;
Expanded polytetrafluoroethylene Graft: Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery t</description>
        </group>
        <group group_id="B2">
          <title>Bovine Carotid Artery Graft</title>
          <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.5" lower_limit="60" upper_limit="70"/>
                    <measurement group_id="B2" value="67.2" lower_limit="45" upper_limit="80"/>
                    <measurement group_id="B3" value="65.7" lower_limit="45" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Primary Graft Patency</title>
        <description>Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).</description>
        <time_frame>One year after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
          <group group_id="O2">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Primary Graft Patency</title>
          <description>Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Primary-Assisted Graft Patency</title>
        <description>Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.</description>
        <time_frame>One year after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Primary-Assisted Graft Patency</title>
          <description>Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Secondary Graft Patency</title>
        <description>Secondary patency is defined as the interval from graft placement to graft failure.</description>
        <time_frame>One year after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Secondary Graft Patency</title>
          <description>Secondary patency is defined as the interval from graft placement to graft failure.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Functional Patency</title>
        <description>Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)</description>
        <time_frame>One year after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Functional Patency</title>
          <description>Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Primary Graft Patency</title>
        <description>Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).</description>
        <time_frame>Two years after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Primary Graft Patency</title>
          <description>Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Primary-Assisted Graft Patency</title>
        <description>Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.</description>
        <time_frame>Two years after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Primary-Assisted Graft Patency</title>
          <description>Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Secondary Graft Patency</title>
        <description>Secondary patency is defined as the interval from graft placement to graft failure.</description>
        <time_frame>Two years after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Secondary Graft Patency</title>
          <description>Secondary patency is defined as the interval from graft placement to graft failure.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Functional Patency</title>
        <description>Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)</description>
        <time_frame>Two years after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Functional Patency</title>
          <description>Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Pseudoaneurysms Formation at the Access Site</title>
        <time_frame>At 6 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Pseudoaneurysms Formation at the Access Site</title>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Pseudoaneurysms Formation at the Access Site</title>
        <time_frame>At 12 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Pseudoaneurysms Formation at the Access Site</title>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Pseudoaneurysms Formation at the Access Site</title>
        <time_frame>At 18 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Pseudoaneurysms Formation at the Access Site</title>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Pseudoaneurysms Formation at the Access Site</title>
        <time_frame>At 24 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Pseudoaneurysms Formation at the Access Site</title>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Surgical Site Infection</title>
        <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
        <time_frame>At 6 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Surgical Site Infection</title>
          <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Surgical Site Infection</title>
        <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
        <time_frame>At 12 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Surgical Site Infection</title>
          <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Surgical Site Infection</title>
        <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
        <time_frame>At 18 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Surgical Site Infection</title>
          <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Surgical Site Infection</title>
        <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
        <time_frame>At 24 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Surgical Site Infection</title>
          <description>The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Steal Syndrome</title>
        <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
        <time_frame>At 6 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Steal Syndrome</title>
          <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Steal Syndrome</title>
        <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
        <time_frame>At 12 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Steal Syndrome</title>
          <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Steal Syndrome</title>
        <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
        <time_frame>At 18 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Steal Syndrome</title>
          <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Steal Syndrome</title>
        <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
        <time_frame>At 24 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Steal Syndrome</title>
          <description>Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</title>
        <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
        <time_frame>At 6 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</title>
          <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</title>
        <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
        <time_frame>At 12 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</title>
          <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</title>
        <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
        <time_frame>At 18 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</title>
          <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</title>
        <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
        <time_frame>At 24 months after Graft Placement</time_frame>
        <population>Data was not collected for this outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
            <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
          </group>
          <group group_id="O2">
            <title>Bovine Carotid Artery Graft</title>
            <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft</title>
          <description>At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention</description>
          <population>Data was not collected for this outcome measure</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Not applicable. Work on this project was discontinued. No adverse event data was collected.</time_frame>
      <desc>No adverse event data was collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Expanded Polytetrafluoroethylene (ePTFE)</title>
          <description>The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.</description>
        </group>
        <group group_id="E2">
          <title>Bovine Carotid Artery Graft</title>
          <description>The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.&#xD;
Bovine Carotid Artery Graft: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Thomas Reifsnyder</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>410-955-7518</phone>
      <email>treifsn1@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03300024
org study id: IRB00069002
nct id: NCT03300024
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic
      grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.
Arteriovenous grafts (AVG) remain reliable substitutes for permanent hemodialysis access in
      scenarios that preclude the placement of arteriovenous fistulae. There is scarcity of
      evidence to support the current preference of synthetic conduits over biologic grafts in
      clinical practice. Advances in the design of AVG's warrant contemporary comparisons between
      synthetic and biologic AVG options. This is especially important as biologic conduits may
      confer an advantage by virtue of their inherent similarity to the native human vasculature.

      The overall goal of this project is to compare one and two year patency (functional, primary,
      primary assisted and secondary), complication rates and re-intervention rates between BCA and
      standard ePTFE grafts. The investigators hypothesize that vascular patient who will receive
      the BCA graft will have improved patency as well as lower complication and re-intervention
      rates compared to the standard ePTFE graft.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will undergo surgery as per standard of care and receive the randomized graft in compliance to National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Arteriovenous graft creation. Surgeries will be elective in nature. The grafts will be placed either in the arm (brachial artery-axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) based on anatomic suitability
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The study will not be blinded because patient side blinding is expected to have minimal to no effect, while physician side blinding is impractical; and difficult to achieve due to the primary surgeon being the one usually who follows up on any intervention or treatment.
measure: Percentage of Patients With Primary Graft Patency
time frame: One year after Graft Placement
description: Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
measure: Percentage of Patients With Primary-Assisted Graft Patency
time frame: One year after Graft Placement
description: Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
measure: Percentage of Patients With Secondary Graft Patency
time frame: One year after Graft Placement
description: Secondary patency is defined as the interval from graft placement to graft failure.
measure: Percentage of Patients With Functional Patency
time frame: One year after Graft Placement
description: Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)
measure: Percentage of Patients With Primary Graft Patency
time frame: Two years after Graft Placement
description: Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
measure: Percentage of Patients With Primary-Assisted Graft Patency
time frame: Two years after Graft Placement
description: Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
measure: Percentage of Patients With Secondary Graft Patency
time frame: Two years after Graft Placement
description: Secondary patency is defined as the interval from graft placement to graft failure.
measure: Percentage of Patients With Functional Patency
time frame: Two years after Graft Placement
description: Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)
measure: Incidence of Pseudoaneurysms Formation at the Access Site
time frame: At 6 months after Graft Placement
measure: Incidence of Pseudoaneurysms Formation at the Access Site
time frame: At 12 months after Graft Placement
measure: Incidence of Pseudoaneurysms Formation at the Access Site
time frame: At 18 months after Graft Placement
measure: Incidence of Pseudoaneurysms Formation at the Access Site
time frame: At 24 months after Graft Placement
measure: Percentage of Patients With Surgical Site Infection
time frame: At 6 months after Graft Placement
description: The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
measure: Percentage of Patients With Surgical Site Infection
time frame: At 12 months after Graft Placement
description: The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
measure: Percentage of Patients With Surgical Site Infection
time frame: At 18 months after Graft Placement
description: The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
measure: Percentage of Patients With Surgical Site Infection
time frame: At 24 months after Graft Placement
description: The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
measure: Steal Syndrome
time frame: At 6 months after Graft Placement
description: Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.
measure: Steal Syndrome
time frame: At 12 months after Graft Placement
description: Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.
measure: Steal Syndrome
time frame: At 18 months after Graft Placement
description: Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.
measure: Steal Syndrome
time frame: At 24 months after Graft Placement
description: Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.
measure: Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
time frame: At 6 months after Graft Placement
description: At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention
measure: Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
time frame: At 12 months after Graft Placement
description: At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention
measure: Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
time frame: At 18 months after Graft Placement
description: At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention
measure: Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft
time frame: At 24 months after Graft Placement
description: At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention
arm group label: Expanded polytetrafluoroethylene (ePTFE)
arm group type: Active Comparator
description: The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.
arm group label: Bovine carotid Artery Graft
arm group type: Experimental
description: The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.
intervention type: Device
intervention name: Expanded polytetrafluoroethylene Graft
description: Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.
arm group label: Expanded polytetrafluoroethylene (ePTFE)
other name: Synthetic Graft
intervention type: Device
intervention name: Bovine Carotid Artery Graft
description: Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.
arm group label: Bovine carotid Artery Graft
other name: Biological Graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Thomas Reifsnyder, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
mesh term: Hemolysis
sharing ipd: No
ipd description: Only key study personnel will be responsible for entering and tracking information. At the end of the study period, study coordinators and research fellows will have access to the final trial dataset and will analyse the data. The final results will be communicated to the PI and co-PI's, the sponsors and participants and will be later published in a peer-reviewed scientific journal.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 