<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/NCT03807661</url>
  </required_header>
  <id_info>
    <org_study_id>EU PMS Revision 4.3-UK</org_study_id>
    <nct_id>NCT03807661</nct_id>
  </id_info>
  <brief_title>Percutaneous Deep Vein Arterialization Post-Market Study</brief_title>
  <acronym>PROMISE UK</acronym>
  <official_title>Percutaneous Deep Vein Arterialization Post-Market Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LimFlow SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LimFlow SA</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this post-market study is to evaluate the safety and effectiveness of the&#xD;
      LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization&#xD;
      in subjects with critical limb ischemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will investigate the safety and effectiveness of the LimFlow System for creating&#xD;
      an arterio-venous fistula in the below-the-knee vascular system using an endovascular,&#xD;
      minimally invasive approach for the treatment of critical limb ischemia in subjects&#xD;
      ineligible for conventional endovascular or surgical limb salvage procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 11, 2019</start_date>
  <completion_date type="Anticipated">October 26, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 26, 2023</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>Amputation-free survival</measure>
    <time_frame>Throughout one year</time_frame>
    <description>Freedom from death or major amputation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>Throughout one year</time_frame>
    <description>Complete index wound healing as assessed by wound pictures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary and secondary patency as assessed by duplex ultrasound</measure>
    <time_frame>Throughout one year</time_frame>
    <description>Stent graft patency as assessed by duplex ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Limb salvage</measure>
    <time_frame>Throughout one year</time_frame>
    <description>Freedom from major amputation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success (procedure completion)</measure>
    <time_frame>Immediately post-procedure</time_frame>
    <description>Procedure completion and immediate morphological success with successful placement of the arterial and venous catheters in the desired location in the limb, and ability to place the stent graft, as assessed angiographically</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success (technical success without death, major amputation, or re-intervention)</measure>
    <time_frame>One month post-procedure</time_frame>
    <description>Combination of technical success without death, major amputation, or re-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Throughout one year</time_frame>
    <description>Quality of Life, as assessed by the EuroQol EQ-5D questionnaire (https://euroqol.org/)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Critical Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>Percutaneous deep vein arterialization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous deep vein arterialization</intervention_name>
    <description>Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach</description>
    <arm_group_label>Percutaneous deep vein arterialization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LimFlow System</intervention_name>
    <description>Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach</description>
    <arm_group_label>Percutaneous deep vein arterialization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be &gt; 21 and &lt; 95 years of age&#xD;
&#xD;
          -  Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford&#xD;
             category 5 or 6&#xD;
&#xD;
          -  Assessment that no conventional surgical or endovascular treatment is possible&#xD;
&#xD;
          -  Proximally, the target in-flow artery at the cross-over point must be treatable with a&#xD;
             3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be &lt;50% stenosed&#xD;
&#xD;
          -  Subject is willing and has adequate support to comply with protocol requirements,&#xD;
             including medication regimen and follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected&#xD;
             coagulation disorders, or current immunodeficiency disorder&#xD;
&#xD;
          -  Prior vein stripping surgery and/or vessel harvesting for CABG in the limb intended&#xD;
             for study&#xD;
&#xD;
          -  Life expectancy less than 12 months&#xD;
&#xD;
          -  Patient currently taking coumarin/warfarin which, in the opinion of the attending&#xD;
             physician, interferes with the patient's treatment&#xD;
&#xD;
          -  Any significant medical condition which, in the attending physician's opinion, may&#xD;
             interfere with the patient's optimal treatment&#xD;
&#xD;
          -  Patient currently participating in another investigational drug or device study that&#xD;
             has not completed the primary endpoint or that clinically interferes with the&#xD;
             endpoints of this treatment&#xD;
&#xD;
          -  Patient unable to give consent&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Documented myocardial infarction or stroke within previous 90 days&#xD;
&#xD;
          -  Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m²)&#xD;
             who are not on hemodialysis&#xD;
&#xD;
          -  Patients with vasculitis and/or untreated popliteal aneurysms&#xD;
&#xD;
          -  Patients with acute limb ischemia&#xD;
&#xD;
          -  Prior peripheral arterial bypass procedure above or below the knee which could inhibit&#xD;
             proximal inflow to the stent graft&#xD;
&#xD;
          -  Lower extremity venous disease with significant edema in the target limb that may&#xD;
             inhibit the procedure and/or jeopardize wound healing, in the investigator's opinion&#xD;
&#xD;
          -  Known or suspected systemic or severe infection (e.g., WIfI foot Infection grade of 3)&#xD;
&#xD;
          -  Known or suspected allergies or contraindications to stainless steel, nickel, or&#xD;
             contrast agent that cannot be adequately pre-treated, or patients who cannot receive&#xD;
             anticoagulation or antiplatelet aggregation therapy&#xD;
&#xD;
          -  Severe heart failure, which in the opinion of the investigator may compromise&#xD;
             subject's ability to safely undergo a percutaneous procedure (e.g., known ejection&#xD;
             fraction of &lt; 40%, NYHA Classification III-IV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>North Bristol NHS Trust</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glenfield Hospital</name>
      <address>
        <city>Leicester</city>
        <zip>LE3 9QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Liverpool and Broadgreen University Hospitals NHS Trust</name>
      <address>
        <city>Liverpool</city>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's University Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW17 0RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manchester University NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Desert foot</keyword>
  <keyword>No-option patients</keyword>
  <keyword>Venous arterialization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided</ipd_description>
  </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/NCT03807661
org study id: EU PMS Revision 4.3-UK
nct id: NCT03807661
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective of this post-market study is to evaluate the safety and effectiveness of the
      LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization
      in subjects with critical limb ischemia.
This study will investigate the safety and effectiveness of the LimFlow System for creating
      an arterio-venous fistula in the below-the-knee vascular system using an endovascular,
      minimally invasive approach for the treatment of critical limb ischemia in subjects
      ineligible for conventional endovascular or surgical limb salvage procedures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Amputation-free survival
time frame: Throughout one year
description: Freedom from death or major amputation
measure: Wound healing
time frame: Throughout one year
description: Complete index wound healing as assessed by wound pictures
measure: Primary and secondary patency as assessed by duplex ultrasound
time frame: Throughout one year
description: Stent graft patency as assessed by duplex ultrasound
measure: Limb salvage
time frame: Throughout one year
description: Freedom from major amputation
measure: Technical success (procedure completion)
time frame: Immediately post-procedure
description: Procedure completion and immediate morphological success with successful placement of the arterial and venous catheters in the desired location in the limb, and ability to place the stent graft, as assessed angiographically
measure: Procedural success (technical success without death, major amputation, or re-intervention)
time frame: One month post-procedure
description: Combination of technical success without death, major amputation, or re-intervention
measure: Quality of Life
time frame: Throughout one year
description: Quality of Life, as assessed by the EuroQol EQ-5D questionnaire (https://euroqol.org/)
arm group label: Percutaneous deep vein arterialization
arm group type: Experimental
description: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
intervention type: Procedure
intervention name: Percutaneous deep vein arterialization
description: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
arm group label: Percutaneous deep vein arterialization
intervention type: Device
intervention name: LimFlow System
description: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
arm group label: Percutaneous deep vein arterialization
criteria: 
gender: All
minimum age: 21 Years
maximum age: 95 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia
sharing ipd: Undecided
ipd description: Undecided