<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/NCT03038438</url>
  </required_header>
  <id_info>
    <org_study_id>APV-ABRE</org_study_id>
    <nct_id>NCT03038438</nct_id>
  </id_info>
  <brief_title>ABRE Clinical Study of the Abre Venous Self-expanding Stent System</brief_title>
  <official_title>A Multi-center, Non-randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Endovascular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Endovascular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for&#xD;
      treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous&#xD;
      occlusive disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2017</start_date>
  <completion_date type="Actual">January 28, 2022</completion_date>
  <primary_completion_date type="Actual">January 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Patency</measure>
    <time_frame>12 Months</time_frame>
    <description>Freedom from occlusion of the stented segment; Freedom from restenosis &gt;=50%; and Freedom from clinically-driven target lesion revascularization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite Major Adverse Events</measure>
    <time_frame>30 Days</time_frame>
    <description>The components of the Major Adverse Events include:&#xD;
All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device Success</measure>
    <time_frame>Index Procedure</time_frame>
    <description>Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lesion Success Obtained at Index Procedure</measure>
    <time_frame>Index Procedure</time_frame>
    <description>Venographic evidence of &lt;50% residual stenosis of the stented segment of the target lesion after post-dilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Index Procedure Success</measure>
    <time_frame>30 days</time_frame>
    <description>Lesion success without procedure-related MAEs prior to hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Patency</measure>
    <time_frame>24 Months, 36 Months</time_frame>
    <description>Primary Patency: Defined as meeting all of the following criteria:&#xD;
Freedom from occlusion of the stented segment of the target lesion;&#xD;
Freedom from restenosis ≥50% of the stented segment of the target lesion;&#xD;
Freedom from clinically driven target lesion revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Assisted Patency</measure>
    <time_frame>12 Months, 24 Months, 36 Months</time_frame>
    <description>Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Patency</measure>
    <time_frame>12 Months, 24 Months, 36 Months</time_frame>
    <description>Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Fracture</measure>
    <time_frame>30 Days, 12 Months, 24 Months, 36 Months</time_frame>
    <description>X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularization</measure>
    <time_frame>30 days, 6 months, 12 months, 24 months, 36 months</time_frame>
    <description>Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delayed Stent Migration</measure>
    <time_frame>12 Months, 24 Months, 36 Months</time_frame>
    <description>Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Events</measure>
    <time_frame>6 Months, 12 Months, 24 Months, 36 Months</time_frame>
    <description>Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Bleeding Related to Index Procedure</measure>
    <time_frame>30 Days, 6 Months, 12 Months, 24 Months, 36 Months</time_frame>
    <description>A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more post-index procedure is related to bleeding occurring during the index procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-Hospitalization</measure>
    <time_frame>0-180, 181-360, 361-720, 721-1080 and 0-1080 days</time_frame>
    <description>Number of subjects that were re-hospitalized due to their target lesion from the Index Procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Villalta Score</measure>
    <time_frame>Baseline to 6 Months, 12 Months, 24 Months, 36 Months</time_frame>
    <description>Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS.&#xD;
Change in Villalta scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months).&#xD;
A negative change is associated with improved outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous Clinical Severity Score (VCSS)</measure>
    <time_frame>Baseline to 6 Months, 12 Months, 24 Months, 36 Months</time_frame>
    <description>VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Follow-up score minus the Baseline score.&#xD;
A negative change is associated with improved outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5 Dimension (EQ-5D) Score</measure>
    <time_frame>Baseline to 6 Months, 12 Months, 24 Months, 36 Months</time_frame>
    <description>Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health).&#xD;
A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, and 24 months) for both the index and VAS scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score</measure>
    <time_frame>Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months</time_frame>
    <description>Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym).&#xD;
Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months).&#xD;
A positive change is associated with improved outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Iliofemoral Venous Obstruction</condition>
  <arm_group>
    <arm_group_label>Abre</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abre Venous Self-expanding Stent System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Abre venous self-expanding stent system</intervention_name>
    <description>venous stent</description>
    <arm_group_label>Abre</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is ≥ 18 and ≤ 80 years of age;&#xD;
&#xD;
          2. Patient has at least one of the following clinical manifestations (i.e. symptoms&#xD;
             and/or signs) of venous disease in lower extremity:&#xD;
&#xD;
               -  CEAP score ≥ 3&#xD;
&#xD;
               -  Venous Clinical Severity Score pain score (VCSS) ≥2&#xD;
&#xD;
               -  Suspected deep vein thrombosis (DVT);&#xD;
&#xD;
          3. Patient is willing and capable of complying with specified follow-up evaluations at&#xD;
             the specified times;&#xD;
&#xD;
          4. Patient has been informed of the nature of the study, agrees to its provisions and has&#xD;
             provided written informed consent, approved by the appropriate Ethics Board.&#xD;
&#xD;
          5. Patient has diagnosis of non-malignant venous obstruction within the common iliac,&#xD;
             external iliac, and/or common femoral vein. The proximal point of the obstruction may&#xD;
             extend to the iliac venous confluence of the inferior vena cava and the distal point&#xD;
             may be at or above the deep femoral vein. Diagnosis must be made based on objective&#xD;
             imaging by using venography and/or intravascular ultrasound (IVUS);&#xD;
&#xD;
          6. Patient has an obstructive lesion defined as:&#xD;
&#xD;
               -  Occluded, or&#xD;
&#xD;
               -  ≥50% in diameter reduction on venography or IVUS, or&#xD;
&#xD;
               -  ≥50% area reduction on IVUS&#xD;
&#xD;
          7. Acute DVT patients should be treated with the Abre stent within 14 days after onset of&#xD;
             symptoms. Patients with acute DVT must first undergo successful treatment of acute&#xD;
             thrombus by catheter based techniques; successful treatment is defined as 30% or less&#xD;
             residual thrombus by venogram, as determined by physician, no bleeding, no symptomatic&#xD;
             pulmonary embolism (confirmed by imaging), and no renal compromise (renal compromise&#xD;
             defined as GFR&gt;30). Patients with underlying obstructive lesions can then be included&#xD;
             in the study within the same procedure;&#xD;
&#xD;
          8. Target vessel can accommodate a 9 French Sheath, from insertion site to target&#xD;
             segment;&#xD;
&#xD;
          9. Exchangeable guidewire must cross target lesion(s) with successful predilation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with DVT in the target limb of which the onset of symptoms is between 15 days&#xD;
             and 6 months prior to planned treatment or patient has an acute DVT anywhere else than&#xD;
             in the target vessel;&#xD;
&#xD;
          2. Patient has peripheral arterial disease causing symptoms in target limb;&#xD;
&#xD;
          3. Patient is pregnant, female patients of child-bearing potential must have a negative&#xD;
             pregnancy test done within 7 days prior to the index procedure;&#xD;
&#xD;
          4. Patient has a known or suspected systemic infection at the time of the index&#xD;
             procedure;&#xD;
&#xD;
          5. Patient has a planned percutaneous or surgical intervention within 30 days prior or 30&#xD;
             days following index procedure, or a contralateral iliofemoral lesion requiring&#xD;
             planned treatment within 12 months;&#xD;
&#xD;
          6. Patient requires femoral endovenectomy and patch venoplasty, greater saphenous vein&#xD;
             ablation, and/or small saphenous vein stripping during the index procedure;&#xD;
&#xD;
          7. Patient has an active vasculitic inflammatory disorder (e.g. Behcet disease)&#xD;
             predisposing the patient to thrombosis and requiring systemic corticosteroid therapy;&#xD;
&#xD;
          8. Patient has impaired renal function (GFR &lt; 30) or is on dialysis;&#xD;
&#xD;
          9. Patient has a platelet count &lt; 50,000 cells/mm3 or &gt; 1,000,000 cells/mm3 and/or a&#xD;
             White Blood Cell count &lt; 3,000 cells/mm3 or &gt; 12,500 cells/mm3;&#xD;
&#xD;
         10. Patient has a history of bleeding diathesis or either a history or presence of heparin&#xD;
             induced thrombocytopenia antibodies;&#xD;
&#xD;
         11. Patient has a known hypersensitivity or contraindication to antiplatelets or&#xD;
             anticoagulation, nitinol, or a contrast sensitivity that cannot be adequately&#xD;
             pre-medicated;&#xD;
&#xD;
         12. Patient has presence of other severe co-morbid conditions, which in the investigator's&#xD;
             opinion may interfere with the patient's compliance with study visits and procedures,&#xD;
             or may confound interpretation of study data (e.g. congestive heart failure Class III&#xD;
             and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy &lt; 1&#xD;
             year);&#xD;
&#xD;
         13. 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. Patient must be able to consent for&#xD;
             themselves;&#xD;
&#xD;
         14. Patient is currently participating in another investigational drug or device study or&#xD;
             observational competitive study.&#xD;
&#xD;
         15. Patient has a vena cava obstruction or lesion extending into the inferior vena cava&#xD;
             (IVC), or the presence of bilateral iliofemoral venous lesions requiring planned&#xD;
             treatment within 12 months;&#xD;
&#xD;
         16. Patient has significant venous bleeding, arterial dissection or other injury requiring&#xD;
             additional percutaneous or surgical intervention prior to enrollment;&#xD;
&#xD;
         17. Patient has a previously placed stent in the ipsilateral venous vasculature;&#xD;
&#xD;
         18. Patient has disease that precludes safe advancement of the venous stent to the target&#xD;
             lesion(s)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erin Murphy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carolinas Health Care System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Black, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph Hospital</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Vascular Experts</name>
      <address>
        <city>Darien</city>
        <state>Connecticut</state>
        <zip>06820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Atlanta Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Health System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Name Medical Center</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</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>The Mount Sinai Health System</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook Medicine</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NC Heart and Vascular Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OhioHealth Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Center of Texas</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Vascular Specialists</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Washington Vascular, PLLC</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assistance Publique - Hôpitaux de Marseille - Hôpital Nord</name>
      <address>
        <city>Marseille</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>D-52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Arnsberg, Karolinen Hospital</name>
      <address>
        <city>Arnsberg</city>
        <zip>D-59759</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galway University Hospitals - University Hospital Galway</name>
      <address>
        <city>Galway</city>
        <zip>H91 YR71</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hesperia Hospital</name>
      <address>
        <city>Modena</city>
        <zip>41125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust - University College London Hospitals</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's &amp; St Thomas' NHS Foundation Trust - St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 28, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <results_first_submitted>January 4, 2021</results_first_submitted>
  <results_first_submitted_qc>February 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2021</results_first_posted>
  <last_update_submitted>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>March 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03038438/Prot_002.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>February 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03038438/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were screened for enrollment based on the study Inclusion/Exclusion criteria between December 2017 and November 2018. Included subjects went on to have one or more Abre stents implanted. The first subject was included on December 19, 2017 and the last subject was included on November 29, 2018.</recruitment_details>
      <pre_assignment_details>Of the 260 enrolled subjects, 200 met inclusion criteria and were implanted with the Abre stent(s).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>ABRE</title>
          <description>Subjects implanted with one or more Abre stents.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>30-Day Follow-Up</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6-Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="193"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>12-Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="191"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>24-Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>36-Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Incarcerated, Moved, or Refused</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No 36-Month Follow-Up</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ABRE</title>
          <description>Subjects included and implanted with one or more Abre stents</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="200"/>
          </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="51.5" spread="15.9"/>
                  </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="133"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </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="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </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="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                  </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="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ireland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (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="29.5" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Patency</title>
        <description>Freedom from occlusion of the stented segment; Freedom from restenosis &gt;=50%; and Freedom from clinically-driven target lesion revascularization</description>
        <time_frame>12 Months</time_frame>
        <population>Proportion Rate</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Patency</title>
          <description>Freedom from occlusion of the stented segment; Freedom from restenosis &gt;=50%; and Freedom from clinically-driven target lesion revascularization</description>
          <population>Proportion Rate</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The primary effectiveness endpoint, primary patency at 12 months, was tested against a PG of 75%. The null and alternative hypotheses tested appear below:&#xD;
H0: π ≤ PG vs. HA: π &gt; PG where π is the primary patency rate at 12 months in the study population and PG is the performance goal of 75%. The primary effectiveness objective will be met if the lower limit of the 97.5% one-sided confidence interval is above 75%.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Single arm study with a hypothesis test comparing to performance goal</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>Fisher Exact</method>
            <param_type>Proportion</param_type>
            <param_value>88.0</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>82.5</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Composite Major Adverse Events</title>
        <description>The components of the Major Adverse Events include:&#xD;
All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration</description>
        <time_frame>30 Days</time_frame>
        <population>Proportion Rate</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Composite Major Adverse Events</title>
          <description>The components of the Major Adverse Events include:&#xD;
All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration</description>
          <population>Proportion Rate</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The primary safety endpoint, major adverse events at 30 days post-procedure, was tested against a performance goal of 12.5%. The null and alternative hypotheses tested appear below:&#xD;
H0: P ≥ PG vs. HA: P &lt; PG where P is the primary safety endpoint at 30 days in the study population and PG is the performance goal.&#xD;
The primary safety objective will be met if the upper limit of the 97.5% one-sided confidence interval is below 12.5%.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Single-arm study with a hypothesis test comparing to performance goal</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>Fisher Exact</method>
            <param_type>Proportion</param_type>
            <param_value>2.0</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>5.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Device Success</title>
        <description>Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure.</description>
        <time_frame>Index Procedure</time_frame>
        <population>302 Abre stents were implanted in 200 included subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Device Success</title>
          <description>Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure.</description>
          <population>302 Abre stents were implanted in 200 included subjects.</population>
          <units>Implanted Stents</units>
          <param>Count of Units</param>
          <units_analyzed>Implanted Stents</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implanted Stents</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lesion Success Obtained at Index Procedure</title>
        <description>Venographic evidence of &lt;50% residual stenosis of the stented segment of the target lesion after post-dilation.</description>
        <time_frame>Index Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Lesion Success Obtained at Index Procedure</title>
          <description>Venographic evidence of &lt;50% residual stenosis of the stented segment of the target lesion after post-dilation.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Index Procedure Success</title>
        <description>Lesion success without procedure-related MAEs prior to hospital discharge</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Index Procedure Success</title>
          <description>Lesion success without procedure-related MAEs prior to hospital discharge</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Primary Patency</title>
        <description>Primary Patency: Defined as meeting all of the following criteria:&#xD;
Freedom from occlusion of the stented segment of the target lesion;&#xD;
Freedom from restenosis ≥50% of the stented segment of the target lesion;&#xD;
Freedom from clinically driven target lesion revascularization.</description>
        <time_frame>24 Months, 36 Months</time_frame>
        <population>SURVIVAL estimate using Kaplan-Meier method. Estimate made at 720 and 1080 days.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Patency</title>
          <description>Primary Patency: Defined as meeting all of the following criteria:&#xD;
Freedom from occlusion of the stented segment of the target lesion;&#xD;
Freedom from restenosis ≥50% of the stented segment of the target lesion;&#xD;
Freedom from clinically driven target lesion revascularization.</description>
          <population>SURVIVAL estimate using Kaplan-Meier method. Estimate made at 720 and 1080 days.</population>
          <units>Event-Free %</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Primary Assisted Patency</title>
        <description>Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.)</description>
        <time_frame>12 Months, 24 Months, 36 Months</time_frame>
        <population>SURVIVAL estimate using Kaplan-Meier method. Estimate made at 360, 720, and 1080 days.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Assisted Patency</title>
          <description>Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.)</description>
          <population>SURVIVAL estimate using Kaplan-Meier method. Estimate made at 360, 720, and 1080 days.</population>
          <units>Event-Free %</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Patency</title>
        <description>Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion.</description>
        <time_frame>12 Months, 24 Months, 36 Months</time_frame>
        <population>SURVIVAL estimate using Kaplan-Meier method. Estimate made at 360, 720, and 1080 days.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Patency</title>
          <description>Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion.</description>
          <population>SURVIVAL estimate using Kaplan-Meier method. Estimate made at 360, 720, and 1080 days.</population>
          <units>Event-Free %</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 Month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stent Fracture</title>
        <description>X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively.</description>
        <time_frame>30 Days, 12 Months, 24 Months, 36 Months</time_frame>
        <population>X-ray for the 30-day visit was only required on the first 30 subjects; included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to 420 days for 12 months assessment, up to 780 days for 24 months assessment, and up to 1140 days for 36 months assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Stent Fracture</title>
          <description>X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively.</description>
          <population>X-ray for the 30-day visit was only required on the first 30 subjects; included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to 420 days for 12 months assessment, up to 780 days for 24 months assessment, and up to 1140 days for 36 months assessment.</population>
          <units>Stents</units>
          <param>Number</param>
          <units_analyzed>Stents</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Stents</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 Day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Stents</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Stents</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Stents</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Stents</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Revascularization</title>
        <description>Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days.</description>
        <time_frame>30 days, 6 months, 12 months, 24 months, 36 months</time_frame>
        <population>Cumulative incidence estimate using Kaplan-Meier method. Estimate made at 30, 180, 360, 720, and 1080 days.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Target Lesion Revascularization</title>
          <description>Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days.</description>
          <population>Cumulative incidence estimate using Kaplan-Meier method. Estimate made at 30, 180, 360, 720, and 1080 days.</population>
          <units>Event %</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Delayed Stent Migration</title>
        <description>Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively.</description>
        <time_frame>12 Months, 24 Months, 36 Months</time_frame>
        <population>Included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Delayed Stent Migration</title>
          <description>Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively.</description>
          <population>Included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging</population>
          <units>Stent number</units>
          <param>Number</param>
          <units_analyzed>Stents</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Stents</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="181"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Stents</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Stents</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Stents</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="214"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Adverse Events</title>
        <description>Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit.</description>
        <time_frame>6 Months, 12 Months, 24 Months, 36 Months</time_frame>
        <population>Cumulative incidence estimate using Kaplan-Meier method. Estimate made at 180, 360, 720, and 1080 days.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Major Adverse Events</title>
          <description>Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit.</description>
          <population>Cumulative incidence estimate using Kaplan-Meier method. Estimate made at 180, 360, 720, and 1080 days.</population>
          <units>Event %</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Within 6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 36 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Bleeding Related to Index Procedure</title>
        <description>A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more post-index procedure is related to bleeding occurring during the index procedure.</description>
        <time_frame>30 Days, 6 Months, 12 Months, 24 Months, 36 Months</time_frame>
        <population>Subjects with an event or a minimum number of follow-up days per time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Major Bleeding Related to Index Procedure</title>
          <description>A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more post-index procedure is related to bleeding occurring during the index procedure.</description>
          <population>Subjects with an event or a minimum number of follow-up days per time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 Days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="197"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Re-Hospitalization</title>
        <description>Number of subjects that were re-hospitalized due to their target lesion from the Index Procedure.</description>
        <time_frame>0-180, 181-360, 361-720, 721-1080 and 0-1080 days</time_frame>
        <population>Subjects with an event or a minimum number of follow-up days per time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Re-Hospitalization</title>
          <description>Number of subjects that were re-hospitalized due to their target lesion from the Index Procedure.</description>
          <population>Subjects with an event or a minimum number of follow-up days per time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0-6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="196"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-36 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0-36 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Villalta Score</title>
        <description>Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS.&#xD;
Change in Villalta scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months).&#xD;
A negative change is associated with improved outcome.</description>
        <time_frame>Baseline to 6 Months, 12 Months, 24 Months, 36 Months</time_frame>
        <population>Subjects with available data at time point</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Villalta Score</title>
          <description>Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS.&#xD;
Change in Villalta scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months).&#xD;
A negative change is associated with improved outcome.</description>
          <population>Subjects with available data at time point</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.5" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.7" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to 36 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.3" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Venous Clinical Severity Score (VCSS)</title>
        <description>VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Follow-up score minus the Baseline score.&#xD;
A negative change is associated with improved outcome.</description>
        <time_frame>Baseline to 6 Months, 12 Months, 24 Months, 36 Months</time_frame>
        <population>Subjects with available data at time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Venous Clinical Severity Score (VCSS)</title>
          <description>VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Follow-up score minus the Baseline score.&#xD;
A negative change is associated with improved outcome.</description>
          <population>Subjects with available data at time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.6" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to 36 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EuroQol-5 Dimension (EQ-5D) Score</title>
        <description>Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health).&#xD;
A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, and 24 months) for both the index and VAS scores.</description>
        <time_frame>Baseline to 6 Months, 12 Months, 24 Months, 36 Months</time_frame>
        <population>Subjects with available data at time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQol-5 Dimension (EQ-5D) Score</title>
          <description>Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health).&#xD;
A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, and 24 months) for both the index and VAS scores.</description>
          <population>Subjects with available data at time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EQ-5D Index Score change from Baseline to 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D Index Score change from Baseline to 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D Index Score change from Baseline to 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D Index Score change from Baseline to 36 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D VAS change from baseline to 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D VAS change from baseline to 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D VAS change from baseline to 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" spread="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D VAS change from baseline to 36 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score</title>
        <description>Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym).&#xD;
Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months).&#xD;
A positive change is associated with improved outcome.</description>
        <time_frame>Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months</time_frame>
        <population>Subjects with available data at time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ABRE</title>
            <description>Subjects implanted with one or more Abre stents.</description>
          </group>
        </group_list>
        <measure>
          <title>Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score</title>
          <description>Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym).&#xD;
Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months).&#xD;
A positive change is associated with improved outcome.</description>
          <population>Subjects with available data at time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VEINES QoL change from Baseline to 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" spread="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VEINES QoL change from Baseline to 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VEINES QoL change from Baseline to 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" spread="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VEINES QoL change from Baseline to 36 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" spread="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VEINES Sym change from Baseline to 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3" spread="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VEINES Sym change from Baseline to 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" spread="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VEINES Sym change from Baseline to 24 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4" spread="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VEINES Sym change from Baseline to 36 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" spread="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through 1080 Days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ABRE</title>
          <description>Subjects implanted with one or more Abre stents.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (24.0)</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="3" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="86" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE LEFT VENTRICULAR FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>BRADYCARDIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CONGESTIVE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>SUPRAVENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>BRCA2 GENE MUTATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>CATARACT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL HERNIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>ABDOMINAL WALL HAEMATOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>ANAL FISSURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>HAEMORRHOIDS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PANCREATITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>RETROPERITONEAL HAEMATOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>SMALL INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>MULTIPLE ORGAN DYSFUNCTION SYNDROME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SWELLING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>VASCULAR STENT OCCLUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>VASCULAR STENT STENOSIS</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>VASCULAR STENT THROMBOSIS</sub_title>
                <counts group_id="E1" events="35" subjects_affected="24" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>CHOLELITHIASIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>INTERVERTEBRAL DISCITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>OSTEOMYELITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PYELONEPHRITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>SEPTIC SHOCK</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>MENISCUS INJURY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>SPINAL COMPRESSION FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>TENDON RUPTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>TIBIA FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>VASCULAR ACCESS SITE HAEMATOMA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>VASCULAR ACCESS SITE HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>VASCULAR GRAFT OCCLUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>HAEMOGLOBIN DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>INTERVERTEBRAL DISC DEGENERATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>INTERVERTEBRAL DISC PROTRUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>LUNG NEOPLASM MALIGNANT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>NONKERATINISING CARCINOMA OF NASOPHARYNX</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PARATHYROID TUMOUR BENIGN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CEREBROVASCULAR ACCIDENT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>CERVICAL RADICULOPATHY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>DEMENTIA ALZHEIMER'S TYPE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>INTRACRANIAL ANEURYSM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>MIGRAINE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>MYELOPATHY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>VASCULAR DEMENTIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>HAEMATURIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>ENDOMETRIOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>HEAVY MENSTRUAL BLEEDING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>INTERMENSTRUAL BLEEDING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>UTEROVAGINAL PROLAPSE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </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="2" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>BRONCHIECTASIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>HAEMOPTYSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>SKIN ULCER</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>STASIS DERMATITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>COLLATERAL CIRCULATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>DEEP VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" events="15" subjects_affected="6" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>LYMPHOEDEMA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PELVIC VENOUS THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PERIPHERAL ARTERY OCCLUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PERIPHERAL ARTERY STENOSIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PERIPHERAL VEIN STENOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>PERIPHERAL VENOUS DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>VARICOSE VEIN</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>VENA CAVA THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>VENOUS HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (24.0)</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="17" subjects_at_risk="200"/>
              </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="17" subjects_affected="17" subjects_at_risk="200"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Stephanie Cihlar</name_or_title>
      <organization>Medtronic</organization>
      <phone>763.258.9524</phone>
      <email>stephanie.a.cihlar@medtronic.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/NCT03038438
org study id: APV-ABRE
nct id: NCT03038438
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for
      treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous
      occlusive disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Patency
time frame: 12 Months
description: Freedom from occlusion of the stented segment; Freedom from restenosis >=50%; and Freedom from clinically-driven target lesion revascularization
measure: Composite Major Adverse Events
time frame: 30 Days
description: The components of the Major Adverse Events include:
All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration
measure: Device Success
time frame: Index Procedure
description: Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure.
measure: Lesion Success Obtained at Index Procedure
time frame: Index Procedure
description: Venographic evidence of <50% residual stenosis of the stented segment of the target lesion after post-dilation.
measure: Index Procedure Success
time frame: 30 days
description: Lesion success without procedure-related MAEs prior to hospital discharge
measure: Primary Patency
time frame: 24 Months, 36 Months
description: Primary Patency: Defined as meeting all of the following criteria:
Freedom from occlusion of the stented segment of the target lesion;
Freedom from restenosis ≥50% of the stented segment of the target lesion;
Freedom from clinically driven target lesion revascularization.
measure: Primary Assisted Patency
time frame: 12 Months, 24 Months, 36 Months
description: Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.)
measure: Secondary Patency
time frame: 12 Months, 24 Months, 36 Months
description: Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion.
measure: Stent Fracture
time frame: 30 Days, 12 Months, 24 Months, 36 Months
description: X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively.
measure: Target Lesion Revascularization
time frame: 30 days, 6 months, 12 months, 24 months, 36 months
description: Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days.
measure: Delayed Stent Migration
time frame: 12 Months, 24 Months, 36 Months
description: Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively.
measure: Major Adverse Events
time frame: 6 Months, 12 Months, 24 Months, 36 Months
description: Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit.
measure: Major Bleeding Related to Index Procedure
time frame: 30 Days, 6 Months, 12 Months, 24 Months, 36 Months
description: A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more post-index procedure is related to bleeding occurring during the index procedure.
measure: Re-Hospitalization
time frame: 0-180, 181-360, 361-720, 721-1080 and 0-1080 days
description: Number of subjects that were re-hospitalized due to their target lesion from the Index Procedure.
measure: Villalta Score
time frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
description: Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS.
Change in Villalta scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months).
A negative change is associated with improved outcome.
measure: Venous Clinical Severity Score (VCSS)
time frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
description: VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Follow-up score minus the Baseline score.
A negative change is associated with improved outcome.
measure: EuroQol-5 Dimension (EQ-5D) Score
time frame: Baseline to 6 Months, 12 Months, 24 Months, 36 Months
description: Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health).
A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, and 24 months) for both the index and VAS scores.
measure: Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score
time frame: Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months
description: Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym).
Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months).
A positive change is associated with improved outcome.
arm group label: Abre
arm group type: Experimental
description: Abre Venous Self-expanding Stent System
intervention type: Device
intervention name: Abre venous self-expanding stent system
description: venous stent
arm group label: Abre
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Erin Murphy, MD
role: Principal Investigator
affiliation: Carolinas Health Care System
last name: Stephen Black, MD
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Ireland
country: Italy
country: United Kingdom
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 