<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/NCT03242343</url>
  </required_header>
  <id_info>
    <org_study_id>CD0121</org_study_id>
    <nct_id>NCT03242343</nct_id>
  </id_info>
  <brief_title>VasQ External Support for Arteriovenous Fistula</brief_title>
  <official_title>A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laminate Medical Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laminate Medical Technologies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective clinical study of the VasQ external support for arteriovenous fistulas.&#xD;
      The device is designed to improve fistula outcomes by optimizing the geometrical&#xD;
      configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote&#xD;
      laminar flow.&#xD;
&#xD;
      All patients will be implanted with the VasQ device and will be followed up for a duration of&#xD;
      24 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 29, 2017</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Actual">October 8, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Patency of AVF</measure>
    <time_frame>6 months post AVF creation</time_frame>
    <description>Proportion of patients with freedom from intervention since device placement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of safety events</measure>
    <time_frame>Device implantation to 6 months post AVF creation</time_frame>
    <description>The occurrence per patient access related safety events</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Arterio-Venous Fistula</condition>
  <condition>ESRD</condition>
  <condition>Steal Syndrome</condition>
  <condition>Aneurysm</condition>
  <condition>Renal Failure</condition>
  <condition>Renal Disease</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Kidney Failure</condition>
  <arm_group>
    <arm_group_label>VasQ device implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints.&#xD;
Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VasQ</intervention_name>
    <description>An external support device for AV fistula</description>
    <arm_group_label>VasQ device implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Main study cohort: Patients referred for creation of a new brachiocephalic fistula who&#xD;
             consent to take part in the study and which are not indicated for a more distal&#xD;
             fistula per treatment guidelines.&#xD;
&#xD;
             Supplementary study cohort: Patients referred for creation of a new forearm fistula&#xD;
             who consent to take part in the study.&#xD;
&#xD;
          2. Male and female participants.&#xD;
&#xD;
          3. Age 18-80 years.&#xD;
&#xD;
          4. Patients willing and able to attend follow up visits over a period of 24 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with the planned index procedure being a revision surgery of an existing&#xD;
             fistula.&#xD;
&#xD;
          2. Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner&#xD;
             diameter by preoperative ultrasound.&#xD;
&#xD;
             Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in&#xD;
             inner diameter by preoperative ultrasound.&#xD;
&#xD;
          3. Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative&#xD;
             ultrasound.&#xD;
&#xD;
             Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by&#xD;
             preoperative ultrasound.&#xD;
&#xD;
          4. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on&#xD;
             preoperative ultrasound. (Scan should include the area between the planned anastomosis&#xD;
             site and the Axillary vein.)&#xD;
&#xD;
          5. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or&#xD;
             intraoperatively) and which preclude adequate fit of the VasQ.&#xD;
&#xD;
          6. Patients with central venous stenosis or obstruction on the side of surgery.&#xD;
&#xD;
          7. Depth of vein greater than 8 mm (on ultrasound) on side of surgery.&#xD;
&#xD;
          8. Known coagulation disorder.&#xD;
&#xD;
          9. Congestive heart failure NYHA class ≥ 3.&#xD;
&#xD;
         10. Prior steal on the side of surgery.&#xD;
&#xD;
         11. Known allergy to nitinol.&#xD;
&#xD;
         12. Life expectancy less than 30 months.&#xD;
&#xD;
         13. Patients expecting to undergo kidney transplant within 6 months of enrollment.&#xD;
&#xD;
         14. Women of child bearing age without documented current negative pregnancy test.&#xD;
&#xD;
         15. Inability to give consent and/or comply with the study follow up schedule.&#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>Noam Zilberman</last_name>
    <role>Study Director</role>
    <affiliation>Laminate Medical Technologies Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grandview Medical Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Kidney Disease &amp; Hypertension Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Medical Center</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lutheran Medical Group/Indiana Ohio Heart</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical College</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte PA</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Wexner Meidcal Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Health System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiothoracic and Vascular Surgeons, P.A.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist DeBakey Heart and Vascular Center,The Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.laminatemedical.com/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Chemla E, Velazquez CC, D'Abate F, Ramachandran V, Maytham G. Arteriovenous fistula construction with the VasQ external support device: a pilot study. J Vasc Access. 2016 May 7;17(3):243-8. doi: 10.5301/jva.5000527. Epub 2016 Apr 14.</citation>
    <PMID>27079670</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>April 11, 2021</last_update_submitted>
  <last_update_submitted_qc>April 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</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>Renal Insufficiency</mesh_term>
    <mesh_term>Aneurysm</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/NCT03242343
org study id: CD0121
nct id: NCT03242343
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas.
      The device is designed to improve fistula outcomes by optimizing the geometrical
      configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote
      laminar flow.

      All patients will be implanted with the VasQ device and will be followed up for a duration of
      24 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Patency of AVF
time frame: 6 months post AVF creation
description: Proportion of patients with freedom from intervention since device placement
measure: Occurrence of safety events
time frame: Device implantation to 6 months post AVF creation
description: The occurrence per patient access related safety events
arm group label: VasQ device implantation
arm group type: Experimental
description: Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints.
Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints.
intervention type: Device
intervention name: VasQ
description: An external support device for AV fistula
arm group label: VasQ device implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Noam Zilberman
role: Study Director
affiliation: Laminate Medical Technologies Ltd.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.laminatemedical.com/
description: Related Info
citation: Chemla E, Velazquez CC, D'Abate F, Ramachandran V, Maytham G. Arteriovenous fistula construction with the VasQ external support device: a pilot study. J Vasc Access. 2016 May 7;17(3):243-8. doi: 10.5301/jva.5000527. Epub 2016 Apr 14.
PMID: 27079670
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Aneurysm
mesh term: Arteriovenous Fistula
mesh term: Fistula
sharing ipd: No