<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/NCT01680835</url>
  </required_header>
  <id_info>
    <org_study_id>CP-1001</org_study_id>
    <nct_id>NCT01680835</nct_id>
  </id_info>
  <brief_title>EverFlex Post Approval Study</brief_title>
  <acronym>DURABILITY PAS</acronym>
  <official_title>The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the EverfLex NitInol STent System Post Approval Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Endovascular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Endovascular</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This post-approval study is designed to confirm the long-term safety and effectiveness of the&#xD;
      EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial&#xD;
      femoral artery (SFA) and proximal popliteal arteries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2013</start_date>
  <completion_date type="Actual">February 4, 2019</completion_date>
  <primary_completion_date type="Actual">October 23, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization</measure>
    <time_frame>3 Years</time_frame>
    <description>Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Freedom From Stent Fracture</measure>
    <time_frame>1, 2 and 3 years</time_frame>
    <description>Determined by x-ray at 1, 2 and 3 years using the following classifications:&#xD;
Class 0 - No strut fractures Class I - Single tine fracture Class II - Multiple tine fractures Class III - Stent fracture(s) with preserved alignment of the components Class IV - Stent fracture(s) with mal-alignment of the components Class V - Stent fracture(s) in a trans-axial spiral configuration&#xD;
AND the following categories:&#xD;
Category A - Restenosis ≤ 50% at site of fracture Category B - Restenosis ≥ 50% at site of fracture Category C - Occlusion at site of fracture Category D - Unable to determine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years</measure>
    <time_frame>1 and 2 years</time_frame>
    <description>Defined as the absence of all-cause mortality occurring within 30-days, absence of any major amputation within 12-/24- months and the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 12-/24- months of the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Freedom From 36-month Amputation</measure>
    <time_frame>3 Years</time_frame>
    <description>Defined as the absence of any major amputation (removal of the target limb or a part of the target limb above the metatarsal line) within 36 months of the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization</measure>
    <time_frame>3 Years</time_frame>
    <description>Defined as the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 36 months of the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Number of Participants Free From Acute Death</measure>
    <time_frame>30 days</time_frame>
    <description>Defined as the absence of all-cause mortality occurring within 30 days of the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Number of Successfully Implanted Stents</measure>
    <time_frame>At procedure</time_frame>
    <description>Defined as the ability to deploy the stent as intended at the treatment site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year</measure>
    <time_frame>1 Year</time_frame>
    <description>Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year</measure>
    <time_frame>1 Year</time_frame>
    <description>Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI &lt; 0.9.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year</measure>
    <time_frame>1 Year</time_frame>
    <description>Defined as an increase in Walking Impairment Questionnaire score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline&#xD;
Scale Range: Minimum score 0 to maximum score 100 Higher values represent better outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome - Number of Adverse Events</measure>
    <time_frame>3 Years</time_frame>
    <description>Number of Adverse Events in the study through 3 Years.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Lower Extremity Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Study cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EverFlex™ Self-Expanding Peripheral Stent System</intervention_name>
    <description>Using the EverFlex™ Self-Expanding Peripheral Stent System to treat atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions 4-18 cm long in subjects with Rutherford Clinical Categories 2-4.</description>
    <arm_group_label>Study cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General Inclusion Criteria&#xD;
&#xD;
          1. Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent&#xD;
             grafts), or occluded lesion(s) located in the native superficial femoral artery or&#xD;
             superficial femoral and proximal popliteal arteries suitable for primary stenting.&#xD;
&#xD;
          2. Has a Rutherford Clinical Category Score of 2, 3 or 4.&#xD;
&#xD;
          3. Is willing to comply with all follow-up evaluations at the specified times.&#xD;
&#xD;
          4. Is ≥ to18 years old.&#xD;
&#xD;
          5. Provides written informed consent prior to enrollment in the study.&#xD;
&#xD;
        Angiographic Inclusion Criteria Subjects must meet all of the following angiographic&#xD;
        inclusion criteria. The implanting physician bases all angiographic inclusion criteria on&#xD;
        visual determination at the time of the procedure.&#xD;
&#xD;
          1. Target lesion(s) located within the native SFA/proximal popliteal: distal point at&#xD;
             least 3 cm above the cortical margin of the femur and proximal point at least 1 cm&#xD;
             below the origin of the profunda femoralis measured by straight posteroanterior (PA)&#xD;
             view for distal lesions, ipsilateral oblique view for proximal lesions.&#xD;
&#xD;
          2. Evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including&#xD;
             stents or stent grafts), or occlusion of target lesion(s).&#xD;
&#xD;
          3. Target lesion(s) total length is ≥ 4 cm and ≤ 18 cm.&#xD;
&#xD;
          4. Target vessel diameter is ≥ 4.5 mm and ≤ 7.5 mm.&#xD;
&#xD;
          5. There is evidence of at least one runoff vessel to the ankle/foot of the limb to be&#xD;
             treated that does not also require treatment for significant (&gt; 50% stenosis or&#xD;
             occlusion) stenosis during the index procedure.&#xD;
&#xD;
        General Exclusion Criteria&#xD;
&#xD;
          1. Has undergone previous implantation of stent(s) or stent graft(s) in the target&#xD;
             vessel.&#xD;
&#xD;
          2. Has a contraindication or known allergy to antiplatelet therapy, anticoagulants,&#xD;
             thrombolytic drugs, contrast media or any other drug used in study according to the&#xD;
             protocol.&#xD;
&#xD;
          3. Has known hypersensitivity to nickel-titanium.&#xD;
&#xD;
          4. Has bleeding diathesis, coagulopathy, known hypercoagulable condition, or refuses&#xD;
             blood transfusion.&#xD;
&#xD;
          5. Female currently breastfeeding, pregnant, or of childbearing potential not using&#xD;
             adequate contraceptive measures.&#xD;
&#xD;
          6. Has life expectancy of less than 1 year.&#xD;
&#xD;
          7. Has planned use of thrombectomy, atherectomy, brachytherapy or laser devices during&#xD;
             procedure.&#xD;
&#xD;
          8. Has previously been enrolled in the DURABILITY PAS study.&#xD;
&#xD;
          9. Has received endovascular treatment of target lesion by percutaneous transluminal&#xD;
             angioplasty or any other means of previous endovascular treatment (e.g. cutting&#xD;
             balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or&#xD;
             laser devices) within six months of the index procedure.&#xD;
&#xD;
         10. Has any planned surgical intervention or endovascular procedure 14 days before or 30&#xD;
             days after the index procedure.&#xD;
&#xD;
         11. Is currently participating in an investigational drug or another device study that has&#xD;
             not completed the primary endpoint or that clinically interferes with the current&#xD;
             study endpoints.&#xD;
&#xD;
         12. Has any co-morbid condition that precludes endovascular treatment.&#xD;
&#xD;
        Angiographic Exclusion Criteria The subject must not meet any of the following angiographic&#xD;
        exclusion criteria. The implanting physician bases all angiographic exclusion criteria on&#xD;
        visual determination at the time of the procedure.&#xD;
&#xD;
          1. Exchangeable guidewire cannot cross the target lesion and/or re-enter true vessel&#xD;
             lumen distal to lesion(s).&#xD;
&#xD;
          2. Presence of significant (&gt; 50% stenosis or occlusion) ipsilateral common femoral&#xD;
             stenosis.&#xD;
&#xD;
          3. Aneurysmal target vessel.&#xD;
&#xD;
          4. Presence of an acute intraluminal thrombus at the proposed lesion site.&#xD;
&#xD;
          5. Perforation, dissection or other injury of the access or target vessel requiring&#xD;
             additional stenting or surgical intervention prior to start of PTA procedure.&#xD;
&#xD;
          6. Focal popliteal disease in the absence of femoral disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jon S Matsumura, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Krishna Rocha-Singh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prairie Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Luke's Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center</name>
      <address>
        <city>Modesto</city>
        <state>California</state>
        <zip>95355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Memorial Hospital</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Health Services</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Coast Cardiovascular Institute, P.A.</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augusta Vascular Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DuPage Medical Group</name>
      <address>
        <city>Downers Grove</city>
        <state>Illinois</state>
        <zip>60515</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rockford Cardiovascular Associates</name>
      <address>
        <city>Rockford</city>
        <state>Illinois</state>
        <zip>61107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Iowa Hospital Corporation</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Solutions, LLC</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sparrow Hospital</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital/Metropolitan Cardiology Consultants</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deborah Heart and Lung Center</name>
      <address>
        <city>Browns Mills</city>
        <state>New Jersey</state>
        <zip>08015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Heart Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Heart Institute</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Institute for Medical Research</name>
      <address>
        <city>Bryn Mawr</city>
        <state>Pennsylvania</state>
        <zip>19010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19147</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Black Hills Cardiovascular Research</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Research</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Surgical Associates</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellin Memorial Hospital</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>October 23, 2019</results_first_submitted>
  <results_first_submitted_qc>December 6, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 26, 2019</results_first_posted>
  <last_update_submitted>December 6, 2019</last_update_submitted>
  <last_update_submitted_qc>December 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
  </condition_browse>
  <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>November 17, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT01680835/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT01680835/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Study Cohort</title>
          <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Cohort</title>
          <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="108"/>
          </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="67.06" spread="11.00"/>
                  </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="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </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="0"/>
                  </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="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization</title>
        <description>Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.</description>
        <time_frame>3 Years</time_frame>
        <population>Subjects experiencing primary outcome within 3 years.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization</title>
          <description>Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.</description>
          <population>Subjects experiencing primary outcome within 3 years.</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="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects experiencing safety composite at 1 Year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects experiencing safety composite at 2 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects experiencing safety composite at 3 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Freedom from primary safety composite event at 36 months compared to a performance goal of 35%</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Log Rank</method>
            <param_type>Kaplan Meier</param_type>
            <param_value>0.771</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>0.678</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome - Freedom From Stent Fracture</title>
        <description>Determined by x-ray at 1, 2 and 3 years using the following classifications:&#xD;
Class 0 - No strut fractures Class I - Single tine fracture Class II - Multiple tine fractures Class III - Stent fracture(s) with preserved alignment of the components Class IV - Stent fracture(s) with mal-alignment of the components Class V - Stent fracture(s) in a trans-axial spiral configuration&#xD;
AND the following categories:&#xD;
Category A - Restenosis ≤ 50% at site of fracture Category B - Restenosis ≥ 50% at site of fracture Category C - Occlusion at site of fracture Category D - Unable to determine</description>
        <time_frame>1, 2 and 3 years</time_frame>
        <population>There were 103 stents evaluated by the Stent Fracture Adjudication Committee.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome - Freedom From Stent Fracture</title>
          <description>Determined by x-ray at 1, 2 and 3 years using the following classifications:&#xD;
Class 0 - No strut fractures Class I - Single tine fracture Class II - Multiple tine fractures Class III - Stent fracture(s) with preserved alignment of the components Class IV - Stent fracture(s) with mal-alignment of the components Class V - Stent fracture(s) in a trans-axial spiral configuration&#xD;
AND the following categories:&#xD;
Category A - Restenosis ≤ 50% at site of fracture Category B - Restenosis ≥ 50% at site of fracture Category C - Occlusion at site of fracture Category D - Unable to determine</description>
          <population>There were 103 stents evaluated by the Stent Fracture Adjudication Committee.</population>
          <units>Stent</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Stent Fracture at 1 Year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Fracture at 2 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Fracture at 3 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </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>Stent Fracture at 1 Year</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No hypothesis Testing for this endpoint.</non_inferiority_desc>
            <param_type>Kaplan Meier</param_type>
            <param_value>1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Stent Fracture at 2 Years</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No hypothesis testing was done for this endpoint.</non_inferiority_desc>
            <param_type>Kaplan Meier</param_type>
            <param_value>0.989</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Stent Fracture at 3 Years</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No hypothesis testing was done for this endpoint</non_inferiority_desc>
            <param_type>Kaplan Meier</param_type>
            <param_value>0.965</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.02</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years</title>
        <description>Defined as the absence of all-cause mortality occurring within 30-days, absence of any major amputation within 12-/24- months and the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 12-/24- months of the procedure.</description>
        <time_frame>1 and 2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years</title>
          <description>Defined as the absence of all-cause mortality occurring within 30-days, absence of any major amputation within 12-/24- months and the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 12-/24- months of the procedure.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects experiencing safety composite at 1 Year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects experiencing safety composite at 2 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </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>Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 1 year</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No hypothesis testing was done at this endpoint</non_inferiority_desc>
            <param_type>Kaplan Meier</param_type>
            <param_value>0.86</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.034</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 2 years</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No hypothesis testing was done for this endpoint.</non_inferiority_desc>
            <param_type>Kaplan Meier</param_type>
            <param_value>0.782</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome - Freedom From 36-month Amputation</title>
        <description>Defined as the absence of any major amputation (removal of the target limb or a part of the target limb above the metatarsal line) within 36 months of the procedure.</description>
        <time_frame>3 Years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome - Freedom From 36-month Amputation</title>
          <description>Defined as the absence of any major amputation (removal of the target limb or a part of the target limb above the metatarsal line) within 36 months of the procedure.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with major amputation within 1 Year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with major amputation within 2 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with major amputation within 3 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </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>Estimate from freedom from major amputation through 3 years.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No hypothesis testing was done for this endpoint.</non_inferiority_desc>
            <param_type>Kaplan Meier</param_type>
            <param_value>0.99</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization</title>
        <description>Defined as the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 36 months of the procedure.</description>
        <time_frame>3 Years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization</title>
          <description>Defined as the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 36 months of the procedure.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects experiencing CD-TLR within 1 Year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects experiencing CD-TLR within 2 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects experiencing CD-TLR within 3 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </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>Freedom from clinically-driven TLR through 3 Years</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Kaplan Meier</param_type>
            <param_value>0.781</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome - Number of Participants Free From Acute Death</title>
        <description>Defined as the absence of all-cause mortality occurring within 30 days of the procedure.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome - Number of Participants Free From Acute Death</title>
          <description>Defined as the absence of all-cause mortality occurring within 30 days of the procedure.</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="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome - Number of Successfully Implanted Stents</title>
        <description>Defined as the ability to deploy the stent as intended at the treatment site.</description>
        <time_frame>At procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome - Number of Successfully Implanted Stents</title>
          <description>Defined as the ability to deploy the stent as intended at the treatment site.</description>
          <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="108"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implanted Stents</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year</title>
        <description>Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.</description>
        <time_frame>1 Year</time_frame>
        <population>There were 95 participants that were evaluated for the Rutherford Clinical Category at 1 Year</population>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year</title>
          <description>Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.</description>
          <population>There were 95 participants that were evaluated for the Rutherford Clinical Category at 1 Year</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="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year</title>
        <description>Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI &lt; 0.9.</description>
        <time_frame>1 Year</time_frame>
        <population>There were 71 participants that were evaluated for the Ankle-Brachial Index at 1 Year</population>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year</title>
          <description>Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI &lt; 0.9.</description>
          <population>There were 71 participants that were evaluated for the Ankle-Brachial Index at 1 Year</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="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year</title>
        <description>Defined as an increase in Walking Impairment Questionnaire score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline&#xD;
Scale Range: Minimum score 0 to maximum score 100 Higher values represent better outcomes</description>
        <time_frame>1 Year</time_frame>
        <population>The total number of participants in the study was 108; number of participants analyzed depends on the questionnaires completed</population>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year</title>
          <description>Defined as an increase in Walking Impairment Questionnaire score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline&#xD;
Scale Range: Minimum score 0 to maximum score 100 Higher values represent better outcomes</description>
          <population>The total number of participants in the study was 108; number of participants analyzed depends on the questionnaires completed</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="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline Score for pain aching cramp</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.42" spread="41.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline Walking Distance Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.08" spread="39.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline Walking Speed Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.77" spread="33.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline Stair Climbing Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.83" spread="36.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome - Number of Adverse Events</title>
        <description>Number of Adverse Events in the study through 3 Years.</description>
        <time_frame>3 Years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Cohort</title>
            <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome - Number of Adverse Events</title>
          <description>Number of Adverse Events in the study through 3 Years.</description>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>36 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Study Cohort</title>
          <description>All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.</description>
        </group>
      </group_list>
      <serious_events>
        <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="8" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="108"/>
              </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="5" subjects_affected="5" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Ischemic colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Stenosis</sub_title>
                <counts group_id="E1" events="31" subjects_affected="21" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vascular stent thrombosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="108"/>
              </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="108"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Genital candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vascular access site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Compression fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Restenosis</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vascular access site haematoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </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="108"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lip and/or oral cavity cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Lung cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oesophageal carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amputation stump pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Carotid artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Transient ischemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Genital rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Respiratory symptom</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cardiac operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hernia repair</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Leg amputation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Regional chemotherapy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Artery dissection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Intermittent claudication</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Ischaemic limb pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jennifer Seamans, M.S., Clinical Research Program Manager</name_or_title>
      <organization>Medtronic</organization>
      <phone>763-398-7455</phone>
      <email>jennifer.l.seamans@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/NCT01680835
org study id: CP-1001
nct id: NCT01680835
lead sponsor: 
has dmc: No
This post-approval study is designed to confirm the long-term safety and effectiveness of the
      EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial
      femoral artery (SFA) and proximal popliteal arteries.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization
time frame: 3 Years
description: Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.
measure: Secondary Outcome - Freedom From Stent Fracture
time frame: 1, 2 and 3 years
description: Determined by x-ray at 1, 2 and 3 years using the following classifications:
Class 0 - No strut fractures Class I - Single tine fracture Class II - Multiple tine fractures Class III - Stent fracture(s) with preserved alignment of the components Class IV - Stent fracture(s) with mal-alignment of the components Class V - Stent fracture(s) in a trans-axial spiral configuration
AND the following categories:
Category A - Restenosis ≤ 50% at site of fracture Category B - Restenosis ≥ 50% at site of fracture Category C - Occlusion at site of fracture Category D - Unable to determine
measure: Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years
time frame: 1 and 2 years
description: Defined as the absence of all-cause mortality occurring within 30-days, absence of any major amputation within 12-/24- months and the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 12-/24- months of the procedure.
measure: Secondary Outcome - Freedom From 36-month Amputation
time frame: 3 Years
description: Defined as the absence of any major amputation (removal of the target limb or a part of the target limb above the metatarsal line) within 36 months of the procedure.
measure: Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization
time frame: 3 Years
description: Defined as the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 36 months of the procedure.
measure: Secondary Outcome - Number of Participants Free From Acute Death
time frame: 30 days
description: Defined as the absence of all-cause mortality occurring within 30 days of the procedure.
measure: Secondary Outcome - Number of Successfully Implanted Stents
time frame: At procedure
description: Defined as the ability to deploy the stent as intended at the treatment site.
measure: Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year
time frame: 1 Year
description: Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.
measure: Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year
time frame: 1 Year
description: Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.
measure: Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year
time frame: 1 Year
description: Defined as an increase in Walking Impairment Questionnaire score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline
Scale Range: Minimum score 0 to maximum score 100 Higher values represent better outcomes
measure: Secondary Outcome - Number of Adverse Events
time frame: 3 Years
description: Number of Adverse Events in the study through 3 Years.
arm group label: Study cohort
arm group type: Experimental
description: All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System.
intervention type: Device
intervention name: EverFlex™ Self-Expanding Peripheral Stent System
description: Using the EverFlex™ Self-Expanding Peripheral Stent System to treat atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions 4-18 cm long in subjects with Rutherford Clinical Categories 2-4.
arm group label: Study cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jon S Matsumura, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Krishna Rocha-Singh, MD
role: Principal Investigator
affiliation: Prairie Heart Institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 