<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/NCT03820947</url>
  </required_header>
  <id_info>
    <org_study_id>MDT18034</org_study_id>
    <nct_id>NCT03820947</nct_id>
  </id_info>
  <brief_title>VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial</brief_title>
  <official_title>Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early &amp; Advanced Stage Superficial Venous Disease</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™&#xD;
      Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of&#xD;
      Early and Advanced Stage Superficial Venous Disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed with two randomized studies and one single arm study.&#xD;
&#xD;
      Two randomized studies are for CEAP 2-5 subjects:&#xD;
&#xD;
        1. VenaSeal vs. Surgical Stripping Study (outside of the United States only)&#xD;
&#xD;
        2. VenaSeal vs. ETA Study&#xD;
&#xD;
      The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU):&#xD;
&#xD;
      1. VLU Study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 5, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2028</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Venous treatment satisfaction questionnaire-early (VenousTSQe)(For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)</measure>
    <time_frame>30 days</time_frame>
    <description>Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)</measure>
    <time_frame>30 days</time_frame>
    <description>Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)</measure>
    <time_frame>Index procedure</time_frame>
    <description>Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to ulcer healing (For VLU study)</measure>
    <time_frame>Index procedure through 12 months</time_frame>
    <description>Time to ulcer healing, calculated through healing confirmation and verified by an independent core laboratory.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anatomic closure of the primary target superficial truncal vein</measure>
    <time_frame>6 months</time_frame>
    <description>Measured via Duplex Ultrasound showing primary target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual primary target vein after surgical stripping procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to return to work</measure>
    <time_frame>Through study completion, an average of 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anatomic closure of primary target vein</measure>
    <time_frame>30 days, and 12, 24, 36, 48 and 60 months (30 days and 12 months only for VenaSeal vs. Surgical Stripping Study)</time_frame>
    <description>Measured via Duplex Ultrasound showing primary target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual primary target vein after surgical stripping procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anatomic closure of target vein</measure>
    <time_frame>30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
    <description>Measured via Duplex Ultrasound showing target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual target vein after surgical stripping procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success of each target vein</measure>
    <time_frame>Index procedure</time_frame>
    <description>Measured via Duplex Ultrasound showing target vein (including primary target vein) closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual target vein after surgical stripping procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reintervention of any target vein</measure>
    <time_frame>Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
    <description>Assessed via number of the target veins requiring retreatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reintervention of any target vein</measure>
    <time_frame>Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs) occurring in the target limb</measure>
    <time_frame>Index procedure through 12 months</time_frame>
    <description>Adverse events occurring in target limb, evaluated from index procedure through 12 months are hypersensitivity to VenaSeal™ adhesive, phlebitis, granuloma, endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), symptomatic deep vein thrombosis (DVT) events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional adverse events</measure>
    <time_frame>Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
    <description>Additional adverse events that will be evaluated through 60 months are symptomatic pulmonary embolism (PE) and serious adverse events (SAEs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization measured by the number of each type of adjunctive treatment.</measure>
    <time_frame>Index procedure through 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization measured by number of healthcare resources and other health related resources utilized for target limb venous reflux disease</measure>
    <time_frame>Index procedure through 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization measured by number of healthcare resources utilized for adverse events</measure>
    <time_frame>Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For VLU study only: Healthcare utilization measured by number of ulcer related healthcare resources utilized</measure>
    <time_frame>Index procedure through 60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to return to normal activities</measure>
    <time_frame>Through study completion, an average of 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-procedural and post-procedural pain</measure>
    <time_frame>Index procedure, and 7 days and 30 days</time_frame>
    <description>Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in venous disease symptoms compared to baseline measured by the revised Venous Clinical Severity Score (rVCSS)</measure>
    <time_frame>7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
    <description>rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in venous disease symptoms compared to baseline as measured by subject self-reporting symptoms</measure>
    <time_frame>7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score compared to baseline</measure>
    <time_frame>30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
    <description>The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) compared to baseline</measure>
    <time_frame>30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
    <description>Items are scored on a 1-5 scale, 5 being a worse outcome. Each of the 5 dimensions are scored separately to obtain a 5-digit code which is converted into a standard value by country. Max &amp; min values vary by country.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the 36-Item Short Form Health Survey (SF-36) compared to baseline</measure>
    <time_frame>30 days, and 6 and 12 months</time_frame>
    <description>The total score ranges from 0 to 100, with higher scores indicating better general health perception.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Venous Dependent Quality of Life (VenousDQoL) compared to baseline</measure>
    <time_frame>30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)</time_frame>
    <description>Measured by 0-5 and 0-7 point (there are two scales in this questionnaire) Likert scale with higher score indicating worst outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider experience evaluating overall satisfaction with the procedure</measure>
    <time_frame>Index procedure</time_frame>
    <description>Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For VLU Study: Ulcer recurrence on the target limb</measure>
    <time_frame>Following ulcer healing through 60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For VLU study: Ulcer healing rate</measure>
    <time_frame>Index procedure through 24 months or until ulcer healing has been confirmed</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For VLU Study: Ulcer-free time</measure>
    <time_frame>Through 60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For VLU Study: Venous treatment satisfaction questionnaire-early (VenousTSQe)</measure>
    <time_frame>30 days</time_frame>
    <description>Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For VLU Study: Venous treatment satisfaction questionnaire- status (VenousTSQs)</measure>
    <time_frame>30 days</time_frame>
    <description>Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For VLU Study: Percentage of target vein treated</measure>
    <time_frame>Index procedure</time_frame>
    <description>Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">506</enrollment>
  <condition>Venous Reflux</condition>
  <arm_group>
    <arm_group_label>VenaSeal™ Closure System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endothermal Ablation (ETA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical Stripping</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VenaSeal™ Closure System VLU Study</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ Closure System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VenaSeal™ Closure System</intervention_name>
    <description>The VenaSeal™ closure system is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.</description>
    <arm_group_label>VenaSeal™ Closure System</arm_group_label>
    <arm_group_label>VenaSeal™ Closure System VLU Study</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endothermal Ablation (ETA)</intervention_name>
    <description>ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.&#xD;
Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.</description>
    <arm_group_label>Endothermal Ablation (ETA)</arm_group_label>
    <other_name>Endovenous laser ablation(EVLA)</other_name>
    <other_name>Radiofrequency ablation (RFA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Stripping</intervention_name>
    <description>Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.</description>
    <arm_group_label>Surgical Stripping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is ≥18 years of age&#xD;
&#xD;
          2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory&#xD;
             saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for&#xD;
             treatment, as confirmed by DUS&#xD;
&#xD;
          3. Eligibility for treatment:&#xD;
&#xD;
               -  VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™&#xD;
                  system and ETA&#xD;
&#xD;
               -  VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the&#xD;
                  VenaSeal™ system and surgical stripping&#xD;
&#xD;
               -  VLU Study: patients should be eligible for treatment with the VenaSeal™ system&#xD;
&#xD;
          4. Treatable refluxing segment of target vein(s) 10 cm in length or longer&#xD;
&#xD;
          5. Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of&#xD;
             the target vein as measured by DUS while patient is standing&#xD;
&#xD;
          6. Patient is willing and capable of complying with specified follow-up evaluations at&#xD;
             the specified times&#xD;
&#xD;
          7. Patient has an ability to understand the requirements of the study and to provide&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has a known history of allergic sensitivities (including but not limited to&#xD;
             cyanoacrylate adhesives), or any other condition, which in the opinion of the&#xD;
             investigator may make the patient more susceptible to cyanoacrylate adhesive&#xD;
             hypersensitivity&#xD;
&#xD;
          2. Patient has known deep vein obstruction in the target limb, as identified by the&#xD;
             site's standard of care&#xD;
&#xD;
          3. Patient has abnormal pulse exam or ABI &lt;0.8&#xD;
&#xD;
          4. Patient has acute superficial thrombophlebitis&#xD;
&#xD;
          5. Patient requires any non-target vein treatments in the contralateral or ipsilateral&#xD;
             limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months&#xD;
             post-procedure&#xD;
&#xD;
          6. Patient has any co-morbid conditions, which in the investigator's opinion may&#xD;
             interfere with the patient's compliance with study visits and procedures, or may&#xD;
             confound interpretation of study data (e.g., congestive heart failure Class III and&#xD;
             IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy &lt; 1 year)&#xD;
&#xD;
          7. IFU contraindications:&#xD;
&#xD;
               -  VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU&#xD;
                  contraindication(s)&#xD;
&#xD;
               -  VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or&#xD;
                  VenaSeal™ system IFU contraindication(s)&#xD;
&#xD;
               -  VLU Study: Patient has VenaSeal™ system IFU contraindication(s)&#xD;
&#xD;
          8. Patient is non-ambulatory&#xD;
&#xD;
          9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at&#xD;
             the time of the index procedure&#xD;
&#xD;
         10. Patient belongs to a vulnerable population per investigator's judgment or patient has&#xD;
             any kind of disorder that compromises his/her ability to give written informed consent&#xD;
             and/or to comply with study procedures&#xD;
&#xD;
         11. Patient is currently participating in an investigational drug or device study when the&#xD;
             data collected could be conflicting or biased due to participation in another study&#xD;
&#xD;
         12. Patient has documented COVID-19 infection currently or within the past 3 months.&#xD;
             Patient is not completely recovered from past COVID-19 infection, per physician's&#xD;
             discretion.&#xD;
&#xD;
         13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as&#xD;
             confirmed by the independent core laboratory&#xD;
&#xD;
         14. VLU Study: Patient has target circumferential ulceration that cannot be captured in a&#xD;
             single photograph (any ulcer curvature around the leg that goes out of sight)&#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>Kathleen Gibson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lake Washington Vascular, US</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manjit Gohel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Addenbrooke's Hospital, UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yavapai Regional Medical Center</name>
      <address>
        <city>Prescott Valley</city>
        <state>Arizona</state>
        <zip>86314-2255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PIMA Heart and Vascular</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Vascular Surgical Associates</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular Care Connecticut</name>
      <address>
        <city>Darien</city>
        <state>Connecticut</state>
        <zip>06820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007-2113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular Care Group</name>
      <address>
        <city>Wellesley</city>
        <state>Massachusetts</state>
        <zip>02482</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York-Presbyterian Hospital/Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OhioHealth Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orion Medical</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Washington Vascular</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004-4623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Coast University Hospital</name>
      <address>
        <city>Birtinya</city>
        <zip>4575</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wollongong Hospital</name>
      <address>
        <city>Wollongong</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Toronto Vascular Clinic</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4L 3Y3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <state>DIjon Cedex</state>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique du Parc</name>
      <address>
        <city>Lyon</city>
        <zip>69006</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis fur Innere Medizin und Gefäβkrankheiten</name>
      <address>
        <city>Halle</city>
        <zip>06108</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Fatebenefratelli e Oftalmico</name>
      <address>
        <city>Milano</city>
        <zip>20121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova Ospendale Sant' Antonio</name>
      <address>
        <city>Padova</city>
        <zip>35127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Saint Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Konkuk University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>143-729</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rijnstate - Locatie Arnhem</name>
      <address>
        <city>Arnhem</city>
        <zip>6815</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)</name>
      <address>
        <city>Granada</city>
        <zip>18016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanitas Hospital Universitario La Zarzuela</name>
      <address>
        <city>Madrid</city>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bedfordshire Hospitals NHS Foundation Trust</name>
      <address>
        <city>Bedford</city>
        <zip>MK42 9DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West London Vascular and Interventional Centre</name>
      <address>
        <city>Harrow</city>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust - Charing Cross Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Switzerland</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Venous reflux</keyword>
  <keyword>Venous leg ulcer</keyword>
  <keyword>Varicose Veins</keyword>
  <keyword>Chronic Venous Insufficiency</keyword>
  <keyword>VenaSeal</keyword>
  <keyword>Endothermal Ablation</keyword>
  <keyword>Surgical Stripping</keyword>
  <keyword>Radiofrequency Ablation</keyword>
  <keyword>Laser Ablation</keyword>
  <keyword>Great Saphenous Vein</keyword>
  <keyword>Small Saphenous Vein</keyword>
  <keyword>Anterior Accessory Saphenous Vein</keyword>
  <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/NCT03820947
org study id: MDT18034
nct id: NCT03820947
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™
      Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of
      Early and Advanced Stage Superficial Venous Disease
The study is designed with two randomized studies and one single arm study.

      Two randomized studies are for CEAP 2-5 subjects:

        1. VenaSeal vs. Surgical Stripping Study (outside of the United States only)

        2. VenaSeal vs. ETA Study

      The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU):

      1. VLU Study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Venous treatment satisfaction questionnaire-early (VenousTSQe)(For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
time frame: 30 days
description: Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).
measure: Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
time frame: 30 days
description: Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).
measure: Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
time frame: Index procedure
description: Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
measure: Time to ulcer healing (For VLU study)
time frame: Index procedure through 12 months
description: Time to ulcer healing, calculated through healing confirmation and verified by an independent core laboratory.
measure: Anatomic closure of the primary target superficial truncal vein
time frame: 6 months
description: Measured via Duplex Ultrasound showing primary target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual primary target vein after surgical stripping procedures.
measure: Time to return to work
time frame: Through study completion, an average of 30 days
measure: Anatomic closure of primary target vein
time frame: 30 days, and 12, 24, 36, 48 and 60 months (30 days and 12 months only for VenaSeal vs. Surgical Stripping Study)
description: Measured via Duplex Ultrasound showing primary target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual primary target vein after surgical stripping procedures.
measure: Anatomic closure of target vein
time frame: 30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
description: Measured via Duplex Ultrasound showing target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual target vein after surgical stripping procedures.
measure: Technical success of each target vein
time frame: Index procedure
description: Measured via Duplex Ultrasound showing target vein (including primary target vein) closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures, or the absence of refluxing or residual target vein after surgical stripping procedures.
measure: Reintervention of any target vein
time frame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
description: Assessed via number of the target veins requiring retreatment.
measure: Time to reintervention of any target vein
time frame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Adverse events (AEs) occurring in the target limb
time frame: Index procedure through 12 months
description: Adverse events occurring in target limb, evaluated from index procedure through 12 months are hypersensitivity to VenaSeal™ adhesive, phlebitis, granuloma, endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), symptomatic deep vein thrombosis (DVT) events.
measure: Additional adverse events
time frame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
description: Additional adverse events that will be evaluated through 60 months are symptomatic pulmonary embolism (PE) and serious adverse events (SAEs).
measure: Healthcare utilization measured by the number of each type of adjunctive treatment.
time frame: Index procedure through 12 months
measure: Healthcare utilization measured by number of healthcare resources and other health related resources utilized for target limb venous reflux disease
time frame: Index procedure through 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Healthcare utilization measured by number of healthcare resources utilized for adverse events
time frame: Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
measure: For VLU study only: Healthcare utilization measured by number of ulcer related healthcare resources utilized
time frame: Index procedure through 60 months
measure: Time to return to normal activities
time frame: Through study completion, an average of 30 days
measure: Intra-procedural and post-procedural pain
time frame: Index procedure, and 7 days and 30 days
description: Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
measure: Change in venous disease symptoms compared to baseline measured by the revised Venous Clinical Severity Score (rVCSS)
time frame: 7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
description: rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.
measure: Change in venous disease symptoms compared to baseline as measured by subject self-reporting symptoms
time frame: 7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
measure: Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score compared to baseline
time frame: 30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
description: The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.
measure: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) compared to baseline
time frame: 30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
description: Items are scored on a 1-5 scale, 5 being a worse outcome. Each of the 5 dimensions are scored separately to obtain a 5-digit code which is converted into a standard value by country. Max & min values vary by country.
measure: Change in the 36-Item Short Form Health Survey (SF-36) compared to baseline
time frame: 30 days, and 6 and 12 months
description: The total score ranges from 0 to 100, with higher scores indicating better general health perception.
measure: Change in the Venous Dependent Quality of Life (VenousDQoL) compared to baseline
time frame: 30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
description: Measured by 0-5 and 0-7 point (there are two scales in this questionnaire) Likert scale with higher score indicating worst outcome.
measure: Provider experience evaluating overall satisfaction with the procedure
time frame: Index procedure
description: Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
measure: For VLU Study: Ulcer recurrence on the target limb
time frame: Following ulcer healing through 60 months
measure: For VLU study: Ulcer healing rate
time frame: Index procedure through 24 months or until ulcer healing has been confirmed
measure: For VLU Study: Ulcer-free time
time frame: Through 60 months
measure: For VLU Study: Venous treatment satisfaction questionnaire-early (VenousTSQe)
time frame: 30 days
description: Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).
measure: For VLU Study: Venous treatment satisfaction questionnaire- status (VenousTSQs)
time frame: 30 days
description: Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).
measure: For VLU Study: Percentage of target vein treated
time frame: Index procedure
description: Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
arm group label: VenaSeal™ Closure System
arm group type: Experimental
description: CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping
arm group label: Endothermal Ablation (ETA)
arm group type: Active Comparator
description: CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA
arm group label: Surgical Stripping
arm group type: Active Comparator
description: CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)
arm group label: VenaSeal™ Closure System VLU Study
arm group type: Other
description: CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ Closure System
intervention type: Device
intervention name: VenaSeal™ Closure System
description: The VenaSeal™ closure system is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
arm group label: VenaSeal™ Closure System
arm group label: VenaSeal™ Closure System VLU Study
intervention type: Device
intervention name: Endothermal Ablation (ETA)
description: ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.
Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
arm group label: Endothermal Ablation (ETA)
other name: Endovenous laser ablation(EVLA)
other name: Radiofrequency ablation (RFA)
intervention type: Procedure
intervention name: Surgical Stripping
description: Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
arm group label: Surgical Stripping
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kathleen Gibson, MD
role: Principal Investigator
affiliation: Lake Washington Vascular, US
last name: Manjit Gohel, MD
role: Principal Investigator
affiliation: Addenbrooke's Hospital, UK
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country: Australia
country: Canada
country: France
country: Germany
country: Italy
country: Korea, Republic of
country: Netherlands
country: Spain
country: United Kingdom
country: United States
country: Switzerland
responsible party type: Sponsor
sharing ipd: No