<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/NCT03246984</url>
  </required_header>
  <id_info>
    <org_study_id>CD0097</org_study_id>
    <nct_id>NCT03246984</nct_id>
  </id_info>
  <brief_title>VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ</brief_title>
  <acronym>VALUE</acronym>
  <official_title>A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy 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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective single arm study enrolling patients who are scheduled for creation of a&#xD;
      new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with&#xD;
      upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the&#xD;
      VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up&#xD;
      period in this study will be for a duration of 12 months, with follow up visits scheduled at&#xD;
      1, 3, 6, 9, and 12 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">January 11, 2021</completion_date>
  <primary_completion_date type="Actual">January 11, 2021</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 AV fistula</measure>
    <time_frame>6 months post AVF creation</time_frame>
    <description>Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US.&#xD;
1 = Success = Intervention free access patency determined by Doppler ultrasound.&#xD;
0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Arterio-Venous Fistula</condition>
  <condition>Kidney Failure, Chronic</condition>
  <condition>Kidney Diseases</condition>
  <condition>Renal Failure Chronic</condition>
  <condition>ESRD</condition>
  <condition>Arteriovenous Fistula Thrombosis</condition>
  <arm_group>
    <arm_group_label>VasQ device implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VasQ</intervention_name>
    <description>VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.</description>
    <arm_group_label>VasQ device implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients referred for creation of a new brachiocephalic or radiocephalic fistula who&#xD;
             consent to take part in the study.&#xD;
&#xD;
          2. Age 18-80 years&#xD;
&#xD;
          3. Male and female participants&#xD;
&#xD;
          4. Patients willing and able to attend follow up visits over a period of 12 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. Target Brachial artery smaller than 2.5 mm or larger than 6 mm or Radial artery&#xD;
             smaller than 2.5 mm or larger than 4 mm in outer diameter by preoperative ultrasound&#xD;
&#xD;
          3. Target vein outer diameter smaller than 2.5 mm by preoperative ultrasound&#xD;
&#xD;
          4. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on&#xD;
             pre-op ultrasound (scan should include the area between the planned anastomosis site&#xD;
             and the Axillary vein)&#xD;
&#xD;
          5. Unusual anatomy or vessel dimensions (observed on pre-operative US or&#xD;
             intraoperatively) and which preclude adequate fit of the VasQ.&#xD;
&#xD;
          6. Patients with prior 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 as evident from the patient's medical history&#xD;
&#xD;
         11. Known allergy to nitinol&#xD;
&#xD;
         12. Life expectancy less than 18 months&#xD;
&#xD;
         13. Patients expected to undergo kidney transplant within 6 months of enrollment&#xD;
&#xD;
         14. Women of child bearing potential 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>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Augsburg</name>
      <address>
        <city>Augsburg</city>
        <zip>86156</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Königin Elisabeth Krankenhaus Herzberge</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz gGmbH</name>
      <address>
        <city>Chemnitz</city>
        <zip>09113</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Cologne</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Ernst von Bergmann gemeinnützige GmbH</name>
      <address>
        <city>Potsdam</city>
        <zip>14467</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harzklinikum Dorothea Christiane Erxleben</name>
      <address>
        <city>Wernigerode</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic of Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>United Kingdom</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 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Thrombosis</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/NCT03246984
org study id: CD0097
nct id: NCT03246984
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective single arm study enrolling patients who are scheduled for creation of a
      new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with
      upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the
      VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up
      period in this study will be for a duration of 12 months, with follow up visits scheduled at
      1, 3, 6, 9, and 12 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary patency of AV fistula
time frame: 6 months post AVF creation
description: Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US.
1 = Success = Intervention free access patency determined by Doppler ultrasound.
0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention
arm group label: VasQ device implantation
arm group type: Experimental
intervention type: Device
intervention name: VasQ
description: VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.
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: 
country: France
country: Germany
country: Spain
country: United Kingdom
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: Kidney Diseases
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Thrombosis
mesh term: Arteriovenous Fistula
mesh term: Fistula
sharing ipd: No