<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/NCT02215369</url>
  </required_header>
  <id_info>
    <org_study_id>PV-VC300</org_study_id>
    <nct_id>NCT02215369</nct_id>
  </id_info>
  <brief_title>SeCure Endovenous Laser Treatment Study</brief_title>
  <acronym>SeCure</acronym>
  <official_title>Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT) 400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Angiodynamics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Angiodynamics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The VenaCure EVLT 400 µm Fiber Kit is currently marketed for the treatment of varicose veins.&#xD;
      AngioDynamics, Inc., the company that manufacturers the VenaCure device, is sponsoring this&#xD;
      study to assess the safety and effectiveness of the VenaCure EndoVenous Laser Treatment&#xD;
      (EVLT) 400 µm Fiber Kit for treatment of incompetent perforator veins (IPVs). The VenaCure&#xD;
      EVLT 400 µm Fiber Kit has not been previously studied by AngioDynamics for the ablation of&#xD;
      IPVs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-arm, prospective, multicenter, non-blinded clinical trial. Study data will&#xD;
      be summarized and submitted to the FDA in a premarket notification once all treated subjects&#xD;
      have completed the 3 month visit. Longer term followup is being performed for publication&#xD;
      purposes.&#xD;
&#xD;
      Patients diagnosed with incompetent Perforator Veins (IPV's) and meet all inclusion and none&#xD;
      of the exclusion criteria will be eligible for this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">January 14, 2019</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Acute Primary Ablation Success</measure>
    <time_frame>10 day</time_frame>
    <description>The primary effectiveness endpoint is &quot;Acute Primary Ablation Success&quot; defined as complete lack of flow or IPV disappearance in the entire treated segment. Success will be measured via Duplex Ultrasound imaging performed 10 days (± 3 days) post procedure. Primary ablation success must be measured by a physician other than the physician that performed the study procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical Success</measure>
    <time_frame>Treatment</time_frame>
    <description>Technical Success, defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended laser energy, will be evaluated as a secondary endpoint for inclusion in device labeling.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Chronic Venous Insufficiency</condition>
  <arm_group>
    <arm_group_label>VenaCure EVLT 400 µm fiber Procedure Kit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VenaCure EVLT 400 µm fiber Procedure Kit</intervention_name>
    <description>The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.</description>
    <arm_group_label>VenaCure EVLT 400 µm fiber Procedure Kit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
        Patients are required to fulfill all the following criteria to be included in the study:&#xD;
&#xD;
          1. Is ≥ 18 years of age&#xD;
&#xD;
          2. IPV(s) to be treated have an outward flow duration of ≥ 0.5 sec immediately after&#xD;
             manual release of manual compression&#xD;
&#xD;
          3. IPV(s) to be treated have a diameter of ≥ 3.5 mm (measured at the level of the fascia)&#xD;
             located superior to foot and distal ankle&#xD;
&#xD;
          4. Has been diagnosed with refractory symptomatic disease (CEAP Class 4b to Class 6)&#xD;
             attributable to the IPV to be treated&#xD;
&#xD;
          5. Has palpable pedal pulses in the study limb&#xD;
&#xD;
          6. Any pathologic superficial saphenous veins have been previously eliminated and were&#xD;
             done so at least more than 30 days prior to the study procedure&#xD;
&#xD;
          7. Is able to ambulate&#xD;
&#xD;
          8. Is able to comprehend and have signed the Informed Consent Form (ICF) to participate&#xD;
             in the study&#xD;
&#xD;
          9. Is willing and able to comply with the Clinical Investigation Plan and follow-up&#xD;
             schedule&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
        Patients will be excluded from participation in the study if they meet any of the&#xD;
        following:&#xD;
&#xD;
          1. Has venous insufficiency secondary to venous obstruction proximal to the intended&#xD;
             treatment site&#xD;
&#xD;
          2. Has thrombus in the vein segment to be treated&#xD;
&#xD;
          3. Has known peripheral arterial disease&#xD;
&#xD;
          4. Has a BMI calculation (BMI = W / H2 ) ≥40kg/m2&#xD;
&#xD;
          5. Is undergoing active anticoagulant therapy for Deep VeinThrombosis or other conditions&#xD;
             (e.g., warfarin, Q10 inhibitors or low molecular weight heparin) or has a history of&#xD;
             Deep Vein Thrombosis within the last 6 months or hypercoagulable state.&#xD;
&#xD;
          6. Has had prior venous procedures in the study limb within the last 30 days (including&#xD;
             but not limited to, thrombolysis / thrombectomy / stenting / ablation / phlebectomy /&#xD;
             sclerotherapy)&#xD;
&#xD;
          7. Has undergone or is expected to undergo any major surgery within 30 days prior to or&#xD;
             within 90 days following the study procedure&#xD;
&#xD;
          8. Has a condition, judged by the treating physician, that may jeopardize the patient's&#xD;
             well-being and/or confound the results or the soundness of the study&#xD;
&#xD;
          9. Is pregnant or lactating at the time of the study procedure or is intending on&#xD;
             becoming pregnant within 90 days following the study procedure&#xD;
&#xD;
         10. Is participating in another clinical study that is contraindicative to the treatment&#xD;
             or outcomes of this investigation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Midwest Institute for Minimally Invasive Therapies</name>
      <address>
        <city>Melrose Park</city>
        <state>Illinois</state>
        <zip>60160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vein Clinics of America</name>
      <address>
        <city>Orland Park</city>
        <state>Illinois</state>
        <zip>60462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Englewood Hospital and Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Vein Center of Virginia</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Washington Vascular</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <results_first_submitted>April 7, 2020</results_first_submitted>
  <results_first_submitted_qc>April 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2020</results_first_posted>
  <last_update_submitted>May 6, 2020</last_update_submitted>
  <last_update_submitted_qc>May 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</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>Venous Insufficiency</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT02215369/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT02215369/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>VenaCure EVLT 400 µm Fiber Procedure Kit</title>
          <description>Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.&#xD;
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>ITT Population</population>
      <group_list>
        <group group_id="B1">
          <title>VenaCure EVLT 400 µm Fiber Procedure Kit</title>
          <description>Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.&#xD;
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="83"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.7" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.2" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acute Primary Ablation Success</title>
        <description>The primary effectiveness endpoint is &quot;Acute Primary Ablation Success&quot; defined as complete lack of flow or IPV disappearance in the entire treated segment. Success will be measured via Duplex Ultrasound imaging performed 10 days (± 3 days) post procedure. Primary ablation success must be measured by a physician other than the physician that performed the study procedure.</description>
        <time_frame>10 day</time_frame>
        <population>Intent to Treat (ITT) Population</population>
        <group_list>
          <group group_id="O1">
            <title>VenaCure EVLT 400 µm Fiber Procedure Kit</title>
            <description>Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.&#xD;
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Primary Ablation Success</title>
          <description>The primary effectiveness endpoint is &quot;Acute Primary Ablation Success&quot; defined as complete lack of flow or IPV disappearance in the entire treated segment. Success will be measured via Duplex Ultrasound imaging performed 10 days (± 3 days) post procedure. Primary ablation success must be measured by a physician other than the physician that performed the study procedure.</description>
          <population>Intent to Treat (ITT) Population</population>
          <units>Veins</units>
          <param>Count of Units</param>
          <units_analyzed>Veins</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Veins</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Technical Success</title>
        <description>Technical Success, defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended laser energy, will be evaluated as a secondary endpoint for inclusion in device labeling.</description>
        <time_frame>Treatment</time_frame>
        <population>Intent to Treat (ITT) Population</population>
        <group_list>
          <group group_id="O1">
            <title>VenaCure EVLT 400 µm Fiber Procedure Kit</title>
            <description>Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.&#xD;
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.</description>
          </group>
        </group_list>
        <measure>
          <title>Technical Success</title>
          <description>Technical Success, defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended laser energy, will be evaluated as a secondary endpoint for inclusion in device labeling.</description>
          <population>Intent to Treat (ITT) Population</population>
          <units>Veins</units>
          <param>Count of Units</param>
          <units_analyzed>Veins</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Veins</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>The safety population was used for all adverse event reporting and analyses.</desc>
      <group_list>
        <group group_id="E1">
          <title>VenaCure EVLT 400 µm Fiber Procedure Kit (Safety Population)</title>
          <description>Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.&#xD;
VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Immune thrombocytopenic purpura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Pneumonia legionella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma gastric</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angiodermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Skin injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Knee arthroplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial restenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Bleeding varicose vein</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Venous occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ariel Bloch</name_or_title>
      <organization>Angiodynamics</organization>
      <phone>7742453646</phone>
      <email>abloch@angiodynamics.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02215369
org study id: PV-VC300
nct id: NCT02215369
lead sponsor: 
has dmc: No
The VenaCure EVLT 400 µm Fiber Kit is currently marketed for the treatment of varicose veins.
      AngioDynamics, Inc., the company that manufacturers the VenaCure device, is sponsoring this
      study to assess the safety and effectiveness of the VenaCure EndoVenous Laser Treatment
      (EVLT) 400 µm Fiber Kit for treatment of incompetent perforator veins (IPVs). The VenaCure
      EVLT 400 µm Fiber Kit has not been previously studied by AngioDynamics for the ablation of
      IPVs.
This is a single-arm, prospective, multicenter, non-blinded clinical trial. Study data will
      be summarized and submitted to the FDA in a premarket notification once all treated subjects
      have completed the 3 month visit. Longer term followup is being performed for publication
      purposes.

      Patients diagnosed with incompetent Perforator Veins (IPV's) and meet all inclusion and none
      of the exclusion criteria will be eligible for this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute Primary Ablation Success
time frame: 10 day
description: The primary effectiveness endpoint is "Acute Primary Ablation Success" defined as complete lack of flow or IPV disappearance in the entire treated segment. Success will be measured via Duplex Ultrasound imaging performed 10 days (± 3 days) post procedure. Primary ablation success must be measured by a physician other than the physician that performed the study procedure.
measure: Technical Success
time frame: Treatment
description: Technical Success, defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended laser energy, will be evaluated as a secondary endpoint for inclusion in device labeling.
arm group label: VenaCure EVLT 400 µm fiber Procedure Kit
arm group type: Experimental
description: Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.
intervention type: Device
intervention name: VenaCure EVLT 400 µm fiber Procedure Kit
description: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.
arm group label: VenaCure EVLT 400 µm fiber Procedure Kit
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Venous Insufficiency
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 