<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/NCT02262949</url>
  </required_header>
  <id_info>
    <org_study_id>BPV-13-002</org_study_id>
    <secondary_id>DRKS00006281</secondary_id>
    <nct_id>NCT02262949</nct_id>
  </id_info>
  <brief_title>A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System</brief_title>
  <acronym>REALITY2</acronym>
  <official_title>A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System (REALITY2)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the deliverability, clinical utility, safety and&#xD;
      effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Major Adverse Events (MAEs)</measure>
    <time_frame>30 days</time_frame>
    <description>Occurence of death or target limb amputation or any target lesion revascularization/target vessel revascularization through 30 days post-index procedure. These events will be assessed by clinical evaluations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stent performance</measure>
    <time_frame>intra operative</time_frame>
    <description>Stent deployment success; defined as a post-deployment stent length deviating &lt;10% from pre-deployment stent length (determined by an independent core lab).&#xD;
Placement accuracy based upon a rating scale completed by the investigator at time of index procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Events (MAEs)</measure>
    <time_frame>1 year</time_frame>
    <description>Occurence of death, stroke, MI, emergent surgical revascularization of the target limb, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 12 months post-index procedure. These events will be assessed by clinical evaluations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion/vessel revascularization</measure>
    <time_frame>1 year</time_frame>
    <description>TLR/TVR rate after 12 months post-index procedure. TLR/TVR will be assessed by clinical evaluations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion patency</measure>
    <time_frame>1 year</time_frame>
    <description>Primary patency (PSVR&lt;2.4) rate at 12 month post-index procedure (measured by DUS). Patency will be assessed by clinical evaluations.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>LifeStent Vascular Stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a single arm study and all subjects receive PTA and implantation of one Life Stent Vascular Stent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LifeStent Vascular Stent</intervention_name>
    <description>PTA followed by implantation of the LifeStent Vascular Stent (stent length 250 mm) in the SFA or popliteal artery.</description>
    <arm_group_label>LifeStent Vascular Stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject or legal representative has been informed of the nature of the evaluation,&#xD;
             agrees to its provisions, and has signed the informed consent form (ICF).&#xD;
&#xD;
          2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.&#xD;
&#xD;
          3. The subject is ≥ 21 years old.&#xD;
&#xD;
          4. Female subjects of childbearing potential must have a negative urine or serum&#xD;
             pregnancy test within seven days prior to index procedure. Female subjects who are&#xD;
             surgically sterile or post-menopausal are exempt from having a pregnancy test.&#xD;
&#xD;
          5. The subject has lifestyle-limiting claudication or mild tissue loss defined as:&#xD;
             Rutherford Category1 2-5 (moderate claudication to minor tissue loss).&#xD;
&#xD;
          6. The target lesion has angiographic evidence of stenosis or restenosis ≥50% or&#xD;
             occlusion in the SFA and/or popliteal artery (by visual estimate) and is amenable to&#xD;
             PTA and stenting.&#xD;
&#xD;
          7. The target vessel reference diameter is (by visual estimate) appropriate for treatment&#xD;
             with available stent diameters of 6.0 and 7.0 mm.&#xD;
&#xD;
          8. There is angiographic evidence of at least one vessel runoff to the foot (at the level&#xD;
             of the malleolus).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is unable or unwilling to provide informed consent or is unable or&#xD;
             unwilling to comply with the study follow-up procedure and visits.&#xD;
&#xD;
          2. The subject has claudication or critical limb ischemia described as Rutherford&#xD;
             Category 0 (asymptomatic), 1 (mild claudication), or 6 (major tissue loss).&#xD;
&#xD;
          3. The subject has a known contraindication (including allergic reaction) or sensitivity&#xD;
             to antiplatelet/anticoagulant medication, nickel, titanium or tantalum.&#xD;
&#xD;
          4. The subject has a known sensitivity to contrast media that is not amenable to&#xD;
             pretreatment with steroids or/and antihistamines.&#xD;
&#xD;
          5. The subject has a history of bleeding diatheses of coagulopathy.&#xD;
&#xD;
          6. The subject has concomitant renal failure with a creatinine of &gt;2.5 mg/dL.&#xD;
&#xD;
          7. The subject has concomitant hepatic insufficiency,thrombophlebitis, uremia, systemic&#xD;
             lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study&#xD;
             procedure.&#xD;
&#xD;
          8. The subject is receiving dialysis or immunosuppressive therapy.&#xD;
&#xD;
          9. The subject is participating in an investigational drug or another investigational&#xD;
             device study.&#xD;
&#xD;
         10. The subject has another medical condition, which, in the opinion of the investigator,&#xD;
             may cause him/her to be noncompliant with the protocol, confound the data&#xD;
             interpretation, or is associated with limited life expectancy of less than two years.&#xD;
&#xD;
         11. The subject has extensive peripheral vascular disease, which,in the opinion of the&#xD;
             investigator, precludes safe insertion of an introducer sheath.&#xD;
&#xD;
         12. The target lesion is located within an aneurysm or associated with an aneurysm in the&#xD;
             vessel segment either proximal or distal to the target lesion.&#xD;
&#xD;
         13. The subject has angiographic evidence of poor inflow, which would be deemed inadequate&#xD;
             to support a vascular bypass graft.&#xD;
&#xD;
         14. The subject is diagnosed with septicemia at the time of the study procedure.&#xD;
&#xD;
         15. Subjects with a stent previously implanted into the target lesion. A target vessel&#xD;
             with a previously placed stent is permitted as long as the subject device will not&#xD;
             come into contact with the previously placed stent during treatment of the target&#xD;
             lesion.&#xD;
&#xD;
         16. Lesions requiring the use of more than one investigational stent.&#xD;
&#xD;
         17. Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs&#xD;
             meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30&#xD;
             days.&#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>Thomas Zeller, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Heart Centre Freiburg, Bad Krozingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Heart Centre Freiburg</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis für Radiologie</name>
      <address>
        <city>Berlin</city>
        <zip>13347</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fürst Stirum Klinik Bruchsal</name>
      <address>
        <city>Bruchsal</city>
        <zip>76646</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RoMed Klinikum Rosenheim</name>
      <address>
        <city>Rosenheim</city>
        <zip>83022</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02262949
org study id: BPV-13-002
secondary id: DRKS00006281
nct id: NCT02262949
lead sponsor: 
has dmc: No
The purpose of this study is to assess the deliverability, clinical utility, safety and
      effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Major Adverse Events (MAEs)
time frame: 30 days
description: Occurence of death or target limb amputation or any target lesion revascularization/target vessel revascularization through 30 days post-index procedure. These events will be assessed by clinical evaluations.
measure: Stent performance
time frame: intra operative
description: Stent deployment success; defined as a post-deployment stent length deviating <10% from pre-deployment stent length (determined by an independent core lab).
Placement accuracy based upon a rating scale completed by the investigator at time of index procedure.
measure: Major Adverse Events (MAEs)
time frame: 1 year
description: Occurence of death, stroke, MI, emergent surgical revascularization of the target limb, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 12 months post-index procedure. These events will be assessed by clinical evaluations.
measure: Target lesion/vessel revascularization
time frame: 1 year
description: TLR/TVR rate after 12 months post-index procedure. TLR/TVR will be assessed by clinical evaluations.
measure: Target lesion patency
time frame: 1 year
description: Primary patency (PSVR<2.4) rate at 12 month post-index procedure (measured by DUS). Patency will be assessed by clinical evaluations.
arm group label: LifeStent Vascular Stent
arm group type: Experimental
description: This is a single arm study and all subjects receive PTA and implantation of one Life Stent Vascular Stent.
intervention type: Device
intervention name: LifeStent Vascular Stent
description: PTA followed by implantation of the LifeStent Vascular Stent (stent length 250 mm) in the SFA or popliteal artery.
arm group label: LifeStent Vascular Stent
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Zeller, Prof. Dr.
role: Principal Investigator
affiliation: University Heart Centre Freiburg, Bad Krozingen
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease