<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/NCT01667393</url>
  </required_header>
  <id_info>
    <org_study_id>IDEV POP-01-US/OUS</org_study_id>
    <nct_id>NCT01667393</nct_id>
  </id_info>
  <brief_title>Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System</brief_title>
  <acronym>PARADIGM</acronym>
  <official_title>Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the&#xD;
      IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive&#xD;
      atherosclerotic popliteal artery disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>January 2013</start_date>
  <completion_date>January 2013</completion_date>
  <primary_completion_date>January 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary patency</measure>
    <time_frame>12 months</time_frame>
    <description>Primary efficacy will be target lesion primary patency at 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MAE-free survival rate.</measure>
    <time_frame>12 months</time_frame>
    <description>Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Peripheral Vascular Disease</condition>
  <arm_group>
    <arm_group_label>IDEV SUPERA Stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Percutaneous Transluminal Angioplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The target lesion will be treated by PTA alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IDEV SUPERA Stent</intervention_name>
    <arm_group_label>IDEV SUPERA Stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous Transluminal Angioplasty</intervention_name>
    <arm_group_label>Percutaneous Transluminal Angioplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has lifestyle limiting claudication or rest pain or at least a single de novo&#xD;
             or restenotic popliteal artery lesion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intervention distal to the target lesion is required at the time of the index&#xD;
             procedure or within 30 days after the index procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <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/NCT01667393
org study id: IDEV POP-01-US/OUS
nct id: NCT01667393
lead sponsor: 
has dmc: Yes
Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the
      IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive
      atherosclerotic popliteal artery disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary patency
time frame: 12 months
description: Primary efficacy will be target lesion primary patency at 12 months.
measure: MAE-free survival rate.
time frame: 12 months
description: Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.
arm group label: IDEV SUPERA Stent
arm group type: Experimental
description: Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.
arm group label: Percutaneous Transluminal Angioplasty
arm group type: Active Comparator
description: The target lesion will be treated by PTA alone.
intervention type: Device
intervention name: IDEV SUPERA Stent
arm group label: IDEV SUPERA Stent
intervention type: Device
intervention name: Percutaneous Transluminal Angioplasty
arm group label: Percutaneous Transluminal Angioplasty
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Peripheral Vascular Diseases
mesh term: Peripheral Arterial Disease