<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/NCT04494035</url>
  </required_header>
  <id_info>
    <org_study_id>TP19-0010</org_study_id>
    <nct_id>NCT04494035</nct_id>
  </id_info>
  <brief_title>AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System</brief_title>
  <acronym>AVATR</acronym>
  <official_title>AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System</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>Yes</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>
      A prospective, single-arm, non-blinded study, intending to treat and collect and evaluate&#xD;
      data in up to ten (10) human subjects who are currently being treated with hemodialysis and&#xD;
      who present with acute thrombosis in their arteriovenous (AV) grafts, treated with the&#xD;
      CAPERE® Thrombectomy System.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor change&#xD;
  </why_stopped>
  <start_date type="Actual">January 14, 2020</start_date>
  <completion_date type="Actual">October 23, 2020</completion_date>
  <primary_completion_date type="Actual">October 23, 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>
    <intervention_model_description>A prospective, single-arm, non-blinded study, intending to treat and collect and evaluate data in up to ten (10) human subjects who are currently being treated with hemodialysis and who present with acute thrombosis in their arteriovenous (AV) grafts, treated with the CAPERE® Thrombectomy System.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Endpoint (Effectiveness)</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Clearance of clot and restoration of blood flow within the affected graft as confirmed via angiographic endpoint in conjunction with a clinical or hemodynamic endpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety Evaluation</measure>
    <time_frame>24 Hours</time_frame>
    <description>Aggregated major adverse events of &lt; 5% (events that cannot be adjudicated in less than 24 hours: death, stroke, major bleeding)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device Safety</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Successful withdrawal of device along with clots without angiographically significant emboli, vessel trauma, entry site aneurysm, major bleeding complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Success</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Ratio of successful thrombus removals and total number of participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombus Removal Rate</measure>
    <time_frame>Post-procedure</time_frame>
    <description>Percent of thrombus removal comparing pre-treatment to post-treatment angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-Day Patency Rate</measure>
    <time_frame>30-days</time_frame>
    <description>Patency of graft at 30-days post-procedure as assessed by ultrasound or other method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success</measure>
    <time_frame>Open</time_frame>
    <description>Ability to deliver dialysis via the graft post procedure for at least one session</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Arteriovenous Graft Thrombosis</condition>
  <arm_group>
    <arm_group_label>AVATR-Toronto</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CAPERE Thrombectomy System</intervention_name>
    <description>Arteriovenous graft thrombectomy</description>
    <arm_group_label>AVATR-Toronto</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dialysis patients who are ≥ 18 years of age&#xD;
&#xD;
          -  Dialysis patients with clinical signs, symptoms and presentation consistent with acute&#xD;
             thrombosis; onset of symptoms ≤ 14 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dialysis patients who are ≤ 18 years of age.&#xD;
&#xD;
          -  Grafts with aneurysmal degeneration&#xD;
&#xD;
          -  Central venous occlusion&#xD;
&#xD;
          -  Patients with infection of the vascular access&#xD;
&#xD;
          -  Patients with active cancer under current therapy, myeloproliferative syndromes,&#xD;
             hyperhomocysteinemia, and heparin-induced thrombocytopenia.&#xD;
&#xD;
          -  Patients with pulmonary embolism (PE) with hemodynamic compromise&#xD;
&#xD;
          -  Any contraindication to systemic or therapeutic doses of heparin or anticoagulants&#xD;
&#xD;
          -  Known anaphylactic reaction of radiographic contrast agents that cannot be pre-&#xD;
             treated&#xD;
&#xD;
          -  Imaging evidence or other evidence that suggests the participant is not appropriate&#xD;
             for mechanical thrombectomy intervention (e.g. recent access site creation where there&#xD;
             are concerns of leak or disruption of the suture line)&#xD;
&#xD;
          -  Female who is pregnant or nursing&#xD;
&#xD;
          -  Concurrent participation in another investigational drug or device treatment study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian Mafeld, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network Toronto General</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Health Network Toronto General</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</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>Thrombosis</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/NCT04494035
org study id: TP19-0010
nct id: NCT04494035
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
A prospective, single-arm, non-blinded study, intending to treat and collect and evaluate
      data in up to ten (10) human subjects who are currently being treated with hemodialysis and
      who present with acute thrombosis in their arteriovenous (AV) grafts, treated with the
      CAPERE® Thrombectomy System.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A prospective, single-arm, non-blinded study, intending to treat and collect and evaluate data in up to ten (10) human subjects who are currently being treated with hemodialysis and who present with acute thrombosis in their arteriovenous (AV) grafts, treated with the CAPERE® Thrombectomy System.
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Primary Endpoint (Effectiveness)
time frame: Intraoperative
description: Clearance of clot and restoration of blood flow within the affected graft as confirmed via angiographic endpoint in conjunction with a clinical or hemodynamic endpoint
measure: Safety Evaluation
time frame: 24 Hours
description: Aggregated major adverse events of < 5% (events that cannot be adjudicated in less than 24 hours: death, stroke, major bleeding)
measure: Device Safety
time frame: Intraoperative
description: Successful withdrawal of device along with clots without angiographically significant emboli, vessel trauma, entry site aneurysm, major bleeding complications
measure: Technical Success
time frame: Intraoperative
description: Ratio of successful thrombus removals and total number of participants
measure: Thrombus Removal Rate
time frame: Post-procedure
description: Percent of thrombus removal comparing pre-treatment to post-treatment angiography
measure: 30-Day Patency Rate
time frame: 30-days
description: Patency of graft at 30-days post-procedure as assessed by ultrasound or other method
measure: Clinical Success
time frame: Open
description: Ability to deliver dialysis via the graft post procedure for at least one session
arm group label: AVATR-Toronto
arm group type: Experimental
description: Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System
intervention type: Device
intervention name: CAPERE Thrombectomy System
description: Arteriovenous graft thrombectomy
arm group label: AVATR-Toronto
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sebastian Mafeld, MD
role: Principal Investigator
affiliation: University Health Network Toronto General
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Thrombosis
sharing ipd: No