<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/NCT04484220</url>
  </required_header>
  <id_info>
    <org_study_id>PS200001</org_study_id>
    <nct_id>NCT04484220</nct_id>
  </id_info>
  <brief_title>Ellipsys Vascular Access System Post Market Surveillance (PS) Study</brief_title>
  <official_title>Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Endovascular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Endovascular</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 proposed clinical study is a prospective, non-randomized, multi-center, single-arm,&#xD;
      observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in&#xD;
      subjects eligible for arteriovenous (AV) fistula.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this post-market surveillance study is to support the short-term&#xD;
      safety of the device and procedure and further assess long-term safety and effectiveness in&#xD;
      subjects treated by newly trained providers of the Ellipsys Vascular Access System in the&#xD;
      creation of a native AV fistula via percutaneous access in subjects who are on hemodialysis&#xD;
      and are medically indicated for the creation of an upper limb anastomosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 13, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative Patency Through 12 months Post-AVF Creation</measure>
    <time_frame>12 months post-procedure</time_frame>
    <description>Freedom from access abandonment from time of access creation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early Occlusion Rate at 7 days</measure>
    <time_frame>7 days post-procedure</time_frame>
    <description>Percent of patients with total occlusion within 7 days of the AVF creation procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study Related Serious Adverse Event (SAE) Rate Through 12 months</measure>
    <time_frame>12 months post-procedure</time_frame>
    <description>Rate of serious adverse events through 12 months related to the device, study procedure, or secondary procedure to maintain or re-establish patency.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary Patency Through 12 months Post-AVF Creation</measure>
    <time_frame>12 months post-procedure</time_frame>
    <description>Freedom from access thrombosis or any intervention designed to facilitate, maintain or re-establish patency measured from time of access creation through 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assisted Primary Patency Through 12 months Post-AVF Creation</measure>
    <time_frame>12 months post-procedure</time_frame>
    <description>Freedom from access thrombosis from time of access creation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Procedures Rate</measure>
    <time_frame>12 months post-procedure</time_frame>
    <description>Number of surgical or percutaneous interventions designed to mature or maintain the AVF or re-establish flow per person-year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Patient Safety</measure>
    <time_frame>12 months post-procedure</time_frame>
    <description>A full characterization of adverse events during the study</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">134</enrollment>
  <condition>Renal Disease, End Stage</condition>
  <condition>Kidney Disease, End-Stage</condition>
  <condition>AV Fistula</condition>
  <condition>Fistulas Arteriovenous</condition>
  <arm_group>
    <arm_group_label>Ellipsys Vascular Access System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients who have chronic kidney disease requiring dialysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ellipsys Vascular Access System</intervention_name>
    <description>The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.</description>
    <arm_group_label>Ellipsys Vascular Access System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or non-pregnant female ≥ 18 years of age and ≤ 80 years of age&#xD;
&#xD;
          2. Life expectancy of at least one year, in the investigator's opinion&#xD;
&#xD;
          3. Diagnosed with ESRD or chronic kidney disease on hemodialysis.&#xD;
&#xD;
          4. Patients deemed medically eligible for upper extremity autogenous AV fistula creation,&#xD;
             per institutional guidelines and/or clinical judgment&#xD;
&#xD;
          5. Adequate quality vein based on pre-operative assessment&#xD;
&#xD;
               1. Adjacent vein diameter of ≥2.0 mm at target anastomosis site&#xD;
&#xD;
               2. Confirmed clinically significant outflow&#xD;
&#xD;
          6. Adequate quality radial artery based on pre-operative assessment&#xD;
&#xD;
             a. Arterial lumen diameter of ≥2.0 mm at target anastomosis site&#xD;
&#xD;
          7. Adequate collateral arterial perfusion with patent palmar arch as demonstrated by&#xD;
             Barbeau Test or Allen's Test.&#xD;
&#xD;
          8. Radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as&#xD;
             determined by pre-procedural ultrasound and confirmed pre-procedure&#xD;
&#xD;
          9. Patient is able to provide written informed consent and attend follow-up examinations&#xD;
             at the enrolling institution&#xD;
&#xD;
             Imaging-based Inclusion Criteria:&#xD;
&#xD;
         10. Confirm radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen&#xD;
             edge as determined by pre-procedural ultrasound and confirmed pre-procedurally&#xD;
&#xD;
         11. Confirm radial artery and adjacent vein diameter of ≥2.0 mm at target anastomosis site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pre-existing ipsilateral vascular disease interfering with the study procedure or&#xD;
             potentially confounding the study results including:&#xD;
&#xD;
               1. Documented or suspected central venous stenosis (≥ 50%) or&#xD;
&#xD;
               2. Upper extremity arterial stenosis or&#xD;
&#xD;
               3. Vascular disease at the radial artery / adjacent vein site&#xD;
&#xD;
          2. Prior vascular surgery at or proximal (central) to the AVF target site interfering&#xD;
             with AVF maturation or other ipsilateral surgery that could potentially confound the&#xD;
             study results such as prior axillary dissection or mastectomy&#xD;
&#xD;
          3. History of steal syndrome from a previous surgical ipsilateral hemodialysis vascular&#xD;
             access which required intervention or abandonment&#xD;
&#xD;
          4. Systolic pressures &lt; 100 mg Hg at the time of screening&#xD;
&#xD;
          5. Suspected or confirmed skin disease at the skin entry site&#xD;
&#xD;
          6. Edema of the upper extremity on the ipsilateral side&#xD;
&#xD;
          7. Immunocompromised subjects due to underlying disease or immunosuppressant therapy such&#xD;
             as sirolimus (Rapamune®) or Prednisone at a dose of &gt; 10 mg per day&#xD;
&#xD;
          8. Known bleeding diathesis, coagulation disorder or medications putting the subject at&#xD;
             increased risk, in the Investigator's judgment&#xD;
&#xD;
          9. Patients with acute or active infection&#xD;
&#xD;
         10. Scheduled kidney transplant within 6 months of enrollment&#xD;
&#xD;
         11. Participation in another clinical investigation (excluding retrospective studies or&#xD;
             studies not requiring a consent form)&#xD;
&#xD;
         12. History of substance abuse or anticipated to be non-compliant with medical care or&#xD;
             study requirements based on investigator judgment&#xD;
&#xD;
         13. Patient has an active COVID-19 infection with ongoing sequela or hospitalization for&#xD;
             treatment of COVID-19.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haimanot Wasse, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heather Catchpole</last_name>
    <phone>7078603395</phone>
    <email>heather.j.catchpole@medtronic.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanford Hospital</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patty Fugal</last_name>
    </contact>
    <investigator>
      <last_name>Edouard Aboian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azura Vascular Care, Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jodi Gray, BSN, RN</last_name>
      <phone>904-353-3664</phone>
      <email>jodi.gray@azuracare.com</email>
    </contact>
    <contact_backup>
      <last_name>Maria Ganas, BSN</last_name>
      <email>maria.ganas@azuracare.com</email>
    </contact_backup>
    <investigator>
      <last_name>Rishi Razdan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Coastal Vascular and Interventional, PLLC</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lana Tadros</last_name>
    </contact>
    <investigator>
      <last_name>Haimanot Wasse, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>The Vascular Care Group</name>
      <address>
        <city>Hyannis</city>
        <state>Massachusetts</state>
        <zip>022601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Gange, PhD</last_name>
      <phone>508-775-1984</phone>
      <email>egagne@vascularbreakthroughs.com</email>
    </contact>
    <contact_backup>
      <last_name>Maria Myslinski</last_name>
      <phone>(508) 775-1984</phone>
      <email>mmyslinski@vascularbreakthroughs.com</email>
    </contact_backup>
    <investigator>
      <last_name>Daniel Gorin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nephrology Kidney Disease Hypertension Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lynda Teator, RN</last_name>
      <phone>702-341-8031</phone>
      <email>Lynda.Teator@AzuraCare.com</email>
    </contact>
    <investigator>
      <last_name>Preteek Sanghera, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Staten Island Hospital</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shannen Belotte</last_name>
      <phone>718-226-8559</phone>
      <email>sbelotte@northwell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Shelly Zou</last_name>
      <phone>(718) 226-6129</phone>
      <email>szou1@northwell.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Vincent Gallo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74135</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Pittsburg Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suzanne Burdin</last_name>
      <phone>412-647-7385</phone>
      <email>burdins@upmc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Michelle Keller</last_name>
      <phone>412-647-7385</phone>
      <email>kellerms3@upmc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Joshua Pinter, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>STAR Vascular Access Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Letti Hudson, RN</last_name>
      <phone>210-223-4444</phone>
      <email>lhudson@raparesearch.com</email>
    </contact>
    <investigator>
      <last_name>Rashid Sharaf, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>San Antonio Kidney Disease Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Richmond Vascular Center</name>
      <address>
        <city>North Chesterfield</city>
        <state>Virginia</state>
        <zip>23236</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Arteriovenous Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484220
org study id: PS200001
nct id: NCT04484220
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm,
      observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in
      subjects eligible for arteriovenous (AV) fistula.
The primary objective of this post-market surveillance study is to support the short-term
      safety of the device and procedure and further assess long-term safety and effectiveness in
      subjects treated by newly trained providers of the Ellipsys Vascular Access System in the
      creation of a native AV fistula via percutaneous access in subjects who are on hemodialysis
      and are medically indicated for the creation of an upper limb anastomosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cumulative Patency Through 12 months Post-AVF Creation
time frame: 12 months post-procedure
description: Freedom from access abandonment from time of access creation
measure: Early Occlusion Rate at 7 days
time frame: 7 days post-procedure
description: Percent of patients with total occlusion within 7 days of the AVF creation procedure
measure: Study Related Serious Adverse Event (SAE) Rate Through 12 months
time frame: 12 months post-procedure
description: Rate of serious adverse events through 12 months related to the device, study procedure, or secondary procedure to maintain or re-establish patency.
measure: Primary Patency Through 12 months Post-AVF Creation
time frame: 12 months post-procedure
description: Freedom from access thrombosis or any intervention designed to facilitate, maintain or re-establish patency measured from time of access creation through 12 months
measure: Assisted Primary Patency Through 12 months Post-AVF Creation
time frame: 12 months post-procedure
description: Freedom from access thrombosis from time of access creation
measure: Secondary Procedures Rate
time frame: 12 months post-procedure
description: Number of surgical or percutaneous interventions designed to mature or maintain the AVF or re-establish flow per person-year.
measure: Overall Patient Safety
time frame: 12 months post-procedure
description: A full characterization of adverse events during the study
arm group label: Ellipsys Vascular Access System
arm group type: Experimental
description: The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients who have chronic kidney disease requiring dialysis.
intervention type: Device
intervention name: Ellipsys Vascular Access System
description: The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.
arm group label: Ellipsys Vascular Access System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Haimanot Wasse, MD
role: Principal Investigator
affiliation: Rush University Medical Center
last name: Heather Catchpole
phone: 7078603395
email: heather.j.catchpole@medtronic.com
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Arteriovenous Fistula
mesh term: Fistula
sharing ipd: No