<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/NCT02228564</url>
  </required_header>
  <id_info>
    <org_study_id>BPV-12-001</org_study_id>
    <nct_id>NCT02228564</nct_id>
  </id_info>
  <brief_title>BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease</brief_title>
  <acronym>BOLSTER</acronym>
  <official_title>A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease (BOLSTER)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>C. R. Bard</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>C. R. Bard</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™&#xD;
      Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Number of Participants With Device and/or Procedure-Related Death or Myocardial Infarction (MI) Through 30 Days, or Any Target Lesion Revascularization (TLR), Target Limb(s) Major Amputation, or Restenosis Through 9-Months Post Index Procedure.</measure>
    <time_frame>9 months post index procedure</time_frame>
    <description>The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.</measure>
    <time_frame>9 months post index procedure</time_frame>
    <description>Major Adverse Events (MAE) defined as device and/or procedure-related death or MI through 30 days, or any TLR or target limb(s) major amputation through 9-months post-index procedure. Major amputation is defined as an amputation at or above the ankle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Lesions With Acute Lesion Success</measure>
    <time_frame>At time of Index Procedure</time_frame>
    <description>Acute Lesion Success defined as attainment of &lt; 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation), as determined by an Independent Angiographic Core Lab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Acute Procedure Success</measure>
    <time_frame>At time of hospital discharge</time_frame>
    <description>Acute Procedure Success defined as lesion success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Devices With Acute Technical Success at Index Procedure</measure>
    <time_frame>At time of index procedure</time_frame>
    <description>Acute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure</measure>
    <time_frame>6, 9, 12, 24, and 36 months post index procedure</time_frame>
    <description>Target Lesion Revascularization (TLR) is defined as the first revascularization procedure (e.g., PTA, atherectomy, etc.) of the target lesion(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Lesion Revascularizations (TLR) were Target Vessel Revascularizations (TVR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.</measure>
    <time_frame>6, 9, 12, 24, and 36 months post index procedure</time_frame>
    <description>Target Vessel Revascularization (TVR) is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Vessel Revascularizations (TVR) were Target Lesion Revascularizations (TLR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure</measure>
    <time_frame>30 days, and 9, 12, 24, and 36 months post index procedure</time_frame>
    <description>Sustained Clinical Success defined as sustained cumulative improvement from baseline value of ≥ 1 Rutherford Category23 at 30-days and 9, 12, 24, and 36-months post-index procedure, as determined by the Investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure</measure>
    <time_frame>9, 12, 24 and 36 months post index procedure</time_frame>
    <description>Primary Patency at 9, 12, 24 and 36-months post-index procedure corresponding to PSVR ≤ 2.4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure</measure>
    <time_frame>9, 12, 24, and 36 months post index procedure</time_frame>
    <description>Primary Assisted Patency at 9-, 12-, 24-, and 36-months post-index procedure corresponding to PSVR ≤ 2.4, as determined by an Independent DUS Core Lab. Primary Assisted Patency is independent of whether or not patency is re-established via an endovascular procedure following restenosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.</measure>
    <time_frame>9,12, 24, and 36 months post index procedure</time_frame>
    <description>Secondary Patency is a measure of success at re-establishing patency following failure of the initial stent placement due to stenosis or re-occlusion. In this study, Secondary Patency was independent of whether or not patency was re-established via an endovascular procedure following restenosis or occlusion, and was analyzed for the Intent to Treat (ITT) population. Secondary patency is defined as a peak systolic velocity ratio (PSVR) ≤ 2.4, as determined by an independent Duplex Ultrasonography (DUS) Core Lab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.</measure>
    <time_frame>30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline.</time_frame>
    <description>The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days,9, 12, 24, and 36 months compared to baseline assessment scores.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">155</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <condition>Peripheral Vascular Disease</condition>
  <condition>Arterial Occlusive Disease</condition>
  <arm_group>
    <arm_group_label>LIFESTREAM™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous transluminal angioplasty (PTA)</intervention_name>
    <description>Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.</description>
    <arm_group_label>LIFESTREAM™</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LIFESTREAM™ covered stent</intervention_name>
    <description>Implantation of the LIFESTREAM™ covered stent</description>
    <arm_group_label>LIFESTREAM™</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        CLINICAL INCLUSION CRITERIA:&#xD;
&#xD;
          -  The subject provides written informed consent using an Informed Consent Form approved&#xD;
             by the Ethics Committee/ Institutional Review Board for the site.&#xD;
&#xD;
          -  Subject agrees to comply with the protocol-mandated follow-up procedures and visits.&#xD;
&#xD;
          -  Subject is a male or non-pregnant female ≥ 21 years old with an expected lifespan&#xD;
             sufficient to allow for completion of all study procedures.&#xD;
&#xD;
          -  Subject has intermittent claudication (Rutherford Category 2-3) or ischemic rest pain&#xD;
             (Rutherford Category 4).&#xD;
&#xD;
          -  Subject is able and willing to comply with any required medication regimen.&#xD;
&#xD;
        ANGIOGRAPHIC INCLUSION CRITERIA:&#xD;
&#xD;
          -  Subject has evidence of single, bilateral, or multiple de novo and/or restenotic&#xD;
             (non-stented) lesion in the native common and/or external iliac artery that is ≥ 50%&#xD;
             stenosed (including total occlusions).&#xD;
&#xD;
          -  The target lesion can be successfully crossed with a guide wire and pre-dilated with&#xD;
             an appropriately sized PTA balloon.&#xD;
&#xD;
          -  The reference vessel diameter is between 4.5 mm -12.0 mm in diameter.&#xD;
&#xD;
          -  The target lesion is ≤ 100 mm in combined length (per side).&#xD;
&#xD;
          -  The subject has angiographic evidence of a patent (&lt; 50% stenosis) profunda and/or&#xD;
             superficial femoral artery (SFA) in the target limb.&#xD;
&#xD;
        CLINICAL EXCLUSION CRITERIA:&#xD;
&#xD;
          -  The subject is unable or unwilling to provide written informed consent or to conform&#xD;
             to the study protocol follow-up procedures and visits.&#xD;
&#xD;
          -  The subject is or plans to become pregnant during the study.&#xD;
&#xD;
          -  The subject is asymptomatic, has mild claudication or critical limb ischemia with&#xD;
             tissue loss described as Rutherford Category 0, 1, 5 or 6.&#xD;
&#xD;
          -  The subject has a vascular graft previously implanted in the native iliac vessel.&#xD;
&#xD;
          -  The subject suffered a hemorrhagic stroke or transient ischemic attack (TIA) within 3&#xD;
             months prior to the index procedure.&#xD;
&#xD;
          -  The subject has a known uncorrectable bleeding diathesis or active coagulopathy.&#xD;
&#xD;
          -  The subject has a serum creatinine ≥ 2.5 mg/dl or is on dialysis.&#xD;
&#xD;
          -  The subject has a known allergy or sensitivity to stainless steel (i.e., Nickel),&#xD;
             ePTFE, or has intolerance to the antiplatelet, anticoagulant or thrombolytic&#xD;
             medications required per the protocol.&#xD;
&#xD;
          -  The subject has a known allergy or sensitivity to contrast media, which cannot be&#xD;
             adequately pre-medicated.&#xD;
&#xD;
          -  The subject had a prior vascular intervention within 30 days before or planned for&#xD;
             within 30 days after the index procedure.&#xD;
&#xD;
          -  The subject has another medical condition, which may cause him/her to be non-compliant&#xD;
             with the protocol, confound the data interpretation, or is associated with a life&#xD;
             expectancy insufficient to allow for the completion of study procedures and follow-up.&#xD;
&#xD;
          -  The subject is currently participating in an investigational drug, biologic, or&#xD;
             another device study.&#xD;
&#xD;
        ANGIOGRAPHIC EXCLUSION CRITERIA:&#xD;
&#xD;
          -  The subject has extensive peripheral vascular disease, which in the opinion of the&#xD;
             Investigator, would preclude safe insertion of an introducer sheath. The ipsilateral&#xD;
             common femoral artery should be patent (&lt; 50% stenosis).&#xD;
&#xD;
          -  The target lesion requires treatment other than angioplasty to facilitate subject&#xD;
             device delivery.&#xD;
&#xD;
          -  The subject has severe calcification of the target lesion, preventing inflation of PTA&#xD;
             balloon.&#xD;
&#xD;
          -  The target lesion has been previously treated with a stent (bare or covered).&#xD;
&#xD;
          -  The subject has angiographic evidence of acute thrombus at the target lesion.&#xD;
&#xD;
          -  The target lesion involves the origin of the internal iliac artery such that&#xD;
             successful treatment of the lesion would require the subject device to cross/occlude&#xD;
             the side branch.&#xD;
&#xD;
          -  The target lesion located in the distal external iliac artery such that successful&#xD;
             treatment of the lesion would require the subject device to cross/occlude side&#xD;
             branches or be exposed to compressive forces associated with the close proximity to&#xD;
             the common femoral artery.&#xD;
&#xD;
          -  The subject has an abdominal aortic aneurysm (AAA) contiguous to the iliac artery&#xD;
             target lesion.&#xD;
&#xD;
          -  The subject has a pre-existing target iliac artery aneurysm or perforation or&#xD;
             dissection of the target iliac artery prior to the initiation of the treatment for&#xD;
             this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John R Laird, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>U. C. Davis Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arkansas Heart Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular and Interventional Specialists of Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>91107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Cardiovascular Medicine</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Network</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Medical Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeland Regional Medical Center</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Worcester</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City Vascular Foundation</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CaroMont Regional Medical Center</name>
      <address>
        <city>Gastonia</city>
        <state>North Carolina</state>
        <zip>28054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Carolina Heart and Vascular</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Donald Guthrie Foundation</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univeristy of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Health Services</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ev.Krankenhaus Königin Elisabeth</name>
      <address>
        <city>Berlin</city>
        <zip>10365</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis fur Interventionelle Angiologie</name>
      <address>
        <city>Kaiserslautern</city>
        <zip>67657</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bonifatius Hospital</name>
      <address>
        <city>Lingen</city>
        <zip>49808</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <results_first_submitted>August 19, 2020</results_first_submitted>
  <results_first_submitted_qc>September 15, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 8, 2020</results_first_posted>
  <disposition_first_submitted>August 2, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>August 2, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 8, 2017</disposition_first_posted>
  <last_update_submitted>September 15, 2020</last_update_submitted>
  <last_update_submitted_qc>September 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lack of perfusion in the extremities</keyword>
  <keyword>Atherosclerosis</keyword>
  <keyword>Intermittent claudication</keyword>
  <keyword>BOLSTER</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Arterial Occlusive Diseases</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 15, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT02228564/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>LIFESTREAM™</title>
          <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="155"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>LIFESTREAM™</title>
          <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="155"/>
          </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="64.3" spread="9.75"/>
                  </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="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                  </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>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Device and/or Procedure-Related Death or Myocardial Infarction (MI) Through 30 Days, or Any Target Lesion Revascularization (TLR), Target Limb(s) Major Amputation, or Restenosis Through 9-Months Post Index Procedure.</title>
        <description>The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.</description>
        <time_frame>9 months post index procedure</time_frame>
        <population>The number of participants (n) may vary from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Device and/or Procedure-Related Death or Myocardial Infarction (MI) Through 30 Days, or Any Target Lesion Revascularization (TLR), Target Limb(s) Major Amputation, or Restenosis Through 9-Months Post Index Procedure.</title>
          <description>The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.</description>
          <population>The number of participants (n) may vary from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.</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="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </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>H0: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is greater than or equal to that of the PG of 19.5%.&#xD;
H1: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is less than that of the PG of 19.5%.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The sample size calculation assumes the following:&#xD;
The LIFESTREAM™ Covered Stent composite event rate is estimated at 10.5% The Performance Goal is set at 19.5% The Type 1 error, α = 0.05 (one-sided). The Type 2 error, β = 0.10 (Power = 1 - β = 90%). The calculated sample size is 139 subjects to be followed through the 9-month follow-up visit (using nQuery 7.0). To accommodate 10% censoring, the sample size is increased to 154.</non_inferiority_desc>
            <p_value>&lt;0.0325</p_value>
            <method>Exact binomial test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.</title>
        <description>Major Adverse Events (MAE) defined as device and/or procedure-related death or MI through 30 days, or any TLR or target limb(s) major amputation through 9-months post-index procedure. Major amputation is defined as an amputation at or above the ankle.</description>
        <time_frame>9 months post index procedure</time_frame>
        <population>The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.</title>
          <description>Major Adverse Events (MAE) defined as device and/or procedure-related death or MI through 30 days, or any TLR or target limb(s) major amputation through 9-months post-index procedure. Major amputation is defined as an amputation at or above the ankle.</description>
          <population>The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.</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="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Lesions With Acute Lesion Success</title>
        <description>Acute Lesion Success defined as attainment of &lt; 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation), as determined by an Independent Angiographic Core Lab.</description>
        <time_frame>At time of Index Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Lesions With Acute Lesion Success</title>
          <description>Acute Lesion Success defined as attainment of &lt; 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation), as determined by an Independent Angiographic Core Lab.</description>
          <units>Lesions</units>
          <param>Count of Units</param>
          <units_analyzed>Lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Acute Procedure Success</title>
        <description>Acute Procedure Success defined as lesion success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.</description>
        <time_frame>At time of hospital discharge</time_frame>
        <population>The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. In this instance, three subjects did not have procedure angiography data.</population>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acute Procedure Success</title>
          <description>Acute Procedure Success defined as lesion success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.</description>
          <population>The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. In this instance, three subjects did not have procedure angiography data.</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="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Devices With Acute Technical Success at Index Procedure</title>
        <description>Acute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator.</description>
        <time_frame>At time of index procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Devices With Acute Technical Success at Index Procedure</title>
          <description>Acute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator.</description>
          <units>Devices</units>
          <param>Count of Units</param>
          <units_analyzed>Devices</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Devices</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure</title>
        <description>Target Lesion Revascularization (TLR) is defined as the first revascularization procedure (e.g., PTA, atherectomy, etc.) of the target lesion(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Lesion Revascularizations (TLR) were Target Vessel Revascularizations (TVR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.</description>
        <time_frame>6, 9, 12, 24, and 36 months post index procedure</time_frame>
        <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure</title>
          <description>Target Lesion Revascularization (TLR) is defined as the first revascularization procedure (e.g., PTA, atherectomy, etc.) of the target lesion(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Lesion Revascularizations (TLR) were Target Vessel Revascularizations (TVR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.</description>
          <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                  </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 months post index procedure</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="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months Post Index Procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.</title>
        <description>Target Vessel Revascularization (TVR) is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Vessel Revascularizations (TVR) were Target Lesion Revascularizations (TLR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.</description>
        <time_frame>6, 9, 12, 24, and 36 months post index procedure</time_frame>
        <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.</title>
          <description>Target Vessel Revascularization (TVR) is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Vessel Revascularizations (TVR) were Target Lesion Revascularizations (TLR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.</description>
          <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                  </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 months post index procedure</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="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months Post Index Procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure</title>
        <description>Sustained Clinical Success defined as sustained cumulative improvement from baseline value of ≥ 1 Rutherford Category23 at 30-days and 9, 12, 24, and 36-months post-index procedure, as determined by the Investigator.</description>
        <time_frame>30 days, and 9, 12, 24, and 36 months post index procedure</time_frame>
        <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure</title>
          <description>Sustained Clinical Success defined as sustained cumulative improvement from baseline value of ≥ 1 Rutherford Category23 at 30-days and 9, 12, 24, and 36-months post-index procedure, as determined by the Investigator.</description>
          <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each 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="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 days post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure</title>
        <description>Primary Patency at 9, 12, 24 and 36-months post-index procedure corresponding to PSVR ≤ 2.4.</description>
        <time_frame>9, 12, 24 and 36 months post index procedure</time_frame>
        <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure</title>
          <description>Primary Patency at 9, 12, 24 and 36-months post-index procedure corresponding to PSVR ≤ 2.4.</description>
          <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each 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="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>9 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure</title>
        <description>Primary Assisted Patency at 9-, 12-, 24-, and 36-months post-index procedure corresponding to PSVR ≤ 2.4, as determined by an Independent DUS Core Lab. Primary Assisted Patency is independent of whether or not patency is re-established via an endovascular procedure following restenosis.</description>
        <time_frame>9, 12, 24, and 36 months post index procedure</time_frame>
        <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure</title>
          <description>Primary Assisted Patency at 9-, 12-, 24-, and 36-months post-index procedure corresponding to PSVR ≤ 2.4, as determined by an Independent DUS Core Lab. Primary Assisted Patency is independent of whether or not patency is re-established via an endovascular procedure following restenosis.</description>
          <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each 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="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>9 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.</title>
        <description>Secondary Patency is a measure of success at re-establishing patency following failure of the initial stent placement due to stenosis or re-occlusion. In this study, Secondary Patency was independent of whether or not patency was re-established via an endovascular procedure following restenosis or occlusion, and was analyzed for the Intent to Treat (ITT) population. Secondary patency is defined as a peak systolic velocity ratio (PSVR) ≤ 2.4, as determined by an independent Duplex Ultrasonography (DUS) Core Lab.</description>
        <time_frame>9,12, 24, and 36 months post index procedure</time_frame>
        <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.</title>
          <description>Secondary Patency is a measure of success at re-establishing patency following failure of the initial stent placement due to stenosis or re-occlusion. In this study, Secondary Patency was independent of whether or not patency was re-established via an endovascular procedure following restenosis or occlusion, and was analyzed for the Intent to Treat (ITT) population. Secondary patency is defined as a peak systolic velocity ratio (PSVR) ≤ 2.4, as determined by an independent Duplex Ultrasonography (DUS) Core Lab.</description>
          <population>The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each 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="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>9 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.</title>
        <description>The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days,9, 12, 24, and 36 months compared to baseline assessment scores.</description>
        <time_frame>30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline.</time_frame>
        <population>The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>LIFESTREAM™</title>
            <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.</title>
          <description>The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days,9, 12, 24, and 36 months compared to baseline assessment scores.</description>
          <population>The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.</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="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30-days Post Index Procedure</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="31.45" spread="25.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.10" spread="26.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.81" spread="26.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months post index procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.34" spread="26.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 Months Post Index Procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.52" spread="27.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>LIFESTREAM™</title>
          <description>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.&#xD;
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a &quot;balloon&quot; at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.&#xD;
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (16.1)</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="11" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Iron Deficiency Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Coronary Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Aortic Valve Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block Complete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Coronary Artery Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vestibular Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Retinal Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Duodenal Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pancreatitis Chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Retroperitoneal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse Drug Reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Device Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Thrombosis In Device</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Vessel Puncture Site Bruise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis Chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gallbladder Perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cholecystitis Infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Groin Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Haematoma Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Kidney Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Perirectal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Scrotal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Subcutaneous Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Reocclusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Restenosis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumothorax Traumatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Postoperative Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Radial Nerve Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Thermal Burn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Toxicity To Various Agents</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Vascular Graft Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Vascular Pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Wrist Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Staphylococcus Test</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal Loss Of Weight</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Diabetes Mellitus Inadequate Control</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Failure To Thrive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Fluid Overload</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Compartment Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Immune-Mediated Necrotising Myopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Rotator Cuff Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Spinal Column Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Spinal Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Brain Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Colon Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Colon Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hepatocellular Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lung Cancer Metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lung Neoplasm Malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Malignant Neoplasm Of Pleura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma Of Lung</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid Artery Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Carotid Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cerebellar Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cervical Myelopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Radial Nerve Palsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychosomatic Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder Mass</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Calculus Urinary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Renal Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Renal Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urethral Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical Dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Genital Prolapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </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" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pneumonia Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pulmonary Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Incisional Drainage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous Fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Diabetic Microangiopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Iliac Artery Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Intermittent Claudication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Leriche Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Dissection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Subclavian Artery Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Subclavian Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Venous Insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (16.1)</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="134" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA (Unspecified)">Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA (Unspecified)">Adverse Drug Reaction</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Device Occlusion</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Vessel Puncture Site Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Peripheral Artery Restenosis</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Dissection</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="155"/>
              </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>Prior to PI publication of site results, sponsor requires publication of multi-centers results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Spark Yamanoglu</name_or_title>
      <organization>Becton Dickinson</organization>
      <phone>480-597-8604</phone>
      <email>Spark.yamanoglu@bd.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/NCT02228564
org study id: BPV-12-001
nct id: NCT02228564
lead sponsor: 
has dmc: No
is fda regulated device: Yes
Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™
      Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Device and/or Procedure-Related Death or Myocardial Infarction (MI) Through 30 Days, or Any Target Lesion Revascularization (TLR), Target Limb(s) Major Amputation, or Restenosis Through 9-Months Post Index Procedure.
time frame: 9 months post index procedure
description: The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.
measure: Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.
time frame: 9 months post index procedure
description: Major Adverse Events (MAE) defined as device and/or procedure-related death or MI through 30 days, or any TLR or target limb(s) major amputation through 9-months post-index procedure. Major amputation is defined as an amputation at or above the ankle.
measure: Number of Lesions With Acute Lesion Success
time frame: At time of Index Procedure
description: Acute Lesion Success defined as attainment of < 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation), as determined by an Independent Angiographic Core Lab.
measure: Number of Participants With Acute Procedure Success
time frame: At time of hospital discharge
description: Acute Procedure Success defined as lesion success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.
measure: Number of Devices With Acute Technical Success at Index Procedure
time frame: At time of index procedure
description: Acute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator.
measure: Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure
time frame: 6, 9, 12, 24, and 36 months post index procedure
description: Target Lesion Revascularization (TLR) is defined as the first revascularization procedure (e.g., PTA, atherectomy, etc.) of the target lesion(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Lesion Revascularizations (TLR) were Target Vessel Revascularizations (TVR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.
measure: Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.
time frame: 6, 9, 12, 24, and 36 months post index procedure
description: Target Vessel Revascularization (TVR) is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Vessel Revascularizations (TVR) were Target Lesion Revascularizations (TLR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.
measure: Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure
time frame: 30 days, and 9, 12, 24, and 36 months post index procedure
description: Sustained Clinical Success defined as sustained cumulative improvement from baseline value of ≥ 1 Rutherford Category23 at 30-days and 9, 12, 24, and 36-months post-index procedure, as determined by the Investigator.
measure: Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
time frame: 9, 12, 24 and 36 months post index procedure
description: Primary Patency at 9, 12, 24 and 36-months post-index procedure corresponding to PSVR ≤ 2.4.
measure: Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
time frame: 9, 12, 24, and 36 months post index procedure
description: Primary Assisted Patency at 9-, 12-, 24-, and 36-months post-index procedure corresponding to PSVR ≤ 2.4, as determined by an Independent DUS Core Lab. Primary Assisted Patency is independent of whether or not patency is re-established via an endovascular procedure following restenosis.
measure: Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.
time frame: 9,12, 24, and 36 months post index procedure
description: Secondary Patency is a measure of success at re-establishing patency following failure of the initial stent placement due to stenosis or re-occlusion. In this study, Secondary Patency was independent of whether or not patency was re-established via an endovascular procedure following restenosis or occlusion, and was analyzed for the Intent to Treat (ITT) population. Secondary patency is defined as a peak systolic velocity ratio (PSVR) ≤ 2.4, as determined by an independent Duplex Ultrasonography (DUS) Core Lab.
measure: Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.
time frame: 30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline.
description: The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days,9, 12, 24, and 36 months compared to baseline assessment scores.
arm group label: LIFESTREAM™
arm group type: Experimental
description: This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
intervention type: Procedure
intervention name: Percutaneous transluminal angioplasty (PTA)
description: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
arm group label: LIFESTREAM™
intervention type: Device
intervention name: LIFESTREAM™ covered stent
description: Implantation of the LIFESTREAM™ covered stent
arm group label: LIFESTREAM™
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: John R Laird, M.D.
role: Principal Investigator
affiliation: U. C. Davis Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: New Zealand
country: United States
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Arterial Occlusive Diseases
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 