<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/NCT03271710</url>
  </required_header>
  <id_info>
    <org_study_id>CSP1121</org_study_id>
    <nct_id>NCT03271710</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System</brief_title>
  <acronym>ENTRAP</acronym>
  <official_title>A Single-Arm, Multicenter Study for the Lower Extremities Using the Vanguard IEP Peripheral Balloon Angioplasty System With Integrated Embolic Protection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Contego Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Contego Medical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with&#xD;
      follow-up to 30 days to determine the acute safety, acute device performance and clinical&#xD;
      performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic&#xD;
      Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic&#xD;
      Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA)&#xD;
      and capture and removal of embolic material during angioplasty for the femoral, iliac,&#xD;
      popliteal and profunda arteries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with&#xD;
      follow-up to 30 days to determine the acute safety, acute device performance and clinical&#xD;
      performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic&#xD;
      Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic&#xD;
      Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA)&#xD;
      and capture and removal of embolic material during angioplasty for the femoral, iliac,&#xD;
      popliteal and profunda arteries.&#xD;
&#xD;
      The Vanguard System has been designed to revascularize iliac and femoro-popliteal PAD while&#xD;
      protecting against embolization at the same time. It is the first system in which the embolic&#xD;
      protection filter is coupled on the same catheter as the angioplasty balloon for use in the&#xD;
      lower extremities. Up to 130 patients will be enrolled into this study and followed for 30&#xD;
      days after post-procedure. Adult patients with lifestyle-limiting claudication or rest pain&#xD;
      (Rutherford categories 2 to 3) who meet all eligibility criteria will be approached for&#xD;
      participation in the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from MAE, defined as death, amputation and target vessel revascularization (TVR)</measure>
    <time_frame>30 days</time_frame>
    <description>Primary safety endpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedural success</measure>
    <time_frame>24 hours or at discharge.</time_frame>
    <description>Defined as &lt;50% residual stenosis without MAE (death, amputation or TVR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical Success</measure>
    <time_frame>Index procedure</time_frame>
    <description>Technical success of the investigational device using questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle-Brachial Index (ABI)</measure>
    <time_frame>Baseline, discharge and 30 days</time_frame>
    <description>Change in Ankle-Brachial Index from baseline, discharge and 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutherford-Becker</measure>
    <time_frame>30 days</time_frame>
    <description>Rutherford-Becker improvement greater than or equal to 1</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Histomorphometric analysis of embolic protection filter content</measure>
    <time_frame>Day 0. Filter collected at end of index procedure.</time_frame>
    <description>Histomorphometric analysis of embolic protection filter content</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Intermittent Claudication</condition>
  <condition>Atherosclerosis of Femoral Artery</condition>
  <arm_group>
    <arm_group_label>Peripheral balloon angioplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries with the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>peripheral balloon angioplasty</intervention_name>
    <description>Percutaneous transluminal angioplasty (PTA) of the lower extremities</description>
    <arm_group_label>Peripheral balloon angioplasty</arm_group_label>
    <other_name>percutaneous transluminal angioplasty (PTA)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients ≥18 years old.&#xD;
&#xD;
          2. Subject has clinically significant symptomatic leg ischemia requiring treatment.&#xD;
&#xD;
          3. Subject has a Rutherford category of 2 - 3.&#xD;
&#xD;
          4. Target lesion in the superficial femoral artery (SFA), common femoral artery, p1&#xD;
             segment of popliteal artery, common iliac artery and external iliac artery (cross-over&#xD;
             access only), and profunda femoris arteries.&#xD;
&#xD;
          5. Target lesion stenosis &gt;50% by investigator's visual estimate.&#xD;
&#xD;
          6. Vessel diameter between 4.0 mm and 8.0 mm at the site of the target lesion.&#xD;
&#xD;
          7. Total target lesion length ≤ 18 cm, and may include a chronic total occlusion ≤ 10 cm.&#xD;
&#xD;
          8. If target lesion is restenotic, the prior PTA must be &gt; 30 days prior to enrollment.&#xD;
&#xD;
          9. If the guide wire traverses the lesion subintimally, it must enter the true lumen&#xD;
             distal to the lesion without the use of a reentry device.&#xD;
&#xD;
         10. Distal vessel diameter at the site of filter deployment of 4.0 mm to 8.0 mm with&#xD;
             sufficient landing zone required for the successful deployment of the integrated&#xD;
             embolic protection filter.&#xD;
&#xD;
         11. Patent popliteal and infrapopliteal arteries; I.e. single vessel runoff or better with&#xD;
             at least one of three vessels patient (&lt;50% stenosis) to the ankle or foot.&#xD;
&#xD;
         12. The patient (or legally authorized representative) is willing to provide written&#xD;
             informed consent and to comply with all study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have undergone prior vascular surgery of the target artery to treat&#xD;
             atherosclerotic disease.&#xD;
&#xD;
          2. History of major amputation in the same limb as the target lesion.&#xD;
&#xD;
          3. Woman who is pregnant or nursing.&#xD;
&#xD;
          4. Subject has Rutherford category of 4- 6.&#xD;
&#xD;
          5. Target lesion(s) within native or synthetic vessel grafts.&#xD;
&#xD;
          6. Use of atherectomy as an adjunctive therapy during the index procedure in the target&#xD;
             lesion or target vessel.&#xD;
&#xD;
          7. Any major (e.g. cardiac, peripheral, abdominal) intervention, including in the&#xD;
             contralateral lim planned within 30 days post index procedure.&#xD;
&#xD;
          8. Presence of other hemodynamically significant outflow lesion in the target limb&#xD;
             requiring intervention within 30 days of enrollment.&#xD;
&#xD;
          9. Subject has significant inflow disease which cannot be treated prior to target lesion&#xD;
             treatment.&#xD;
&#xD;
         10. Presence of aneurysm in the target vessel.&#xD;
&#xD;
         11. Acute limb occlusion due to thrombotic occlusion of the target limb.&#xD;
&#xD;
         12. In-stent restenosis of target lesion.&#xD;
&#xD;
         13. Severe calcification that renders the target lesion lesion resistant to angioplasty.&#xD;
&#xD;
         14. Visible acute thrombus in the target lesion&#xD;
&#xD;
         15. Intolerance to antiplatelet, anticoagulant or thrombolytic therapy medications that&#xD;
             would be administered during the trial.&#xD;
&#xD;
         16. Known hypersensitivity to contrast media that cannot be adequately premedicated.&#xD;
&#xD;
         17. Known hypersensitivity to nickel and/or titanium.&#xD;
&#xD;
         18. Acute Myocardial Infarction within 30 days prior to the index procedure.&#xD;
&#xD;
         19. Subject has a known coagulopathy or bleeding diathesis, or INR &lt;1.5.&#xD;
&#xD;
         20. Platelet count &lt;100,000 mm3/L or &gt;700,000 mm3/L&#xD;
&#xD;
         21. Concomitant renal failure with a serum creatinine &gt; 2.5 mg/dL or receiving dialysis.&#xD;
&#xD;
         22. Patient is currently participating in an interventional study, investigational drug or&#xD;
             device study that has not completed the primary endpoint, that may potentially&#xD;
             confound the results of this trial or that would limit the subject's compliance with&#xD;
             the follow-up requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Zeller, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitäts-Herzzentrum Freiburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OLV Hospital Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imelda Hospital / Vascular Science Research Center</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Blasius</name>
      <address>
        <city>Dendermonde</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RZ Heilig Hart Hospital</name>
      <address>
        <city>Tienen</city>
        <zip>3300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Interventional Cardiology and Vascular Medicine, Department of Angiology, Universitäts-Herzzentrum Freiburg</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sankt Gertrauden-Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <zip>10713</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daikonissenkrankenhaus Flensburg</name>
      <address>
        <city>Flensburg</city>
        <zip>24939</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MVZ/Prof. Mathey Prof. Schofer Clinic</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>April 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Distal embolization</keyword>
  <keyword>Percutaneous transluminal angioplasty</keyword>
  <keyword>Integrated embolic protection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Intermittent Claudication</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Site specific individual participant data is available to each research site via export from EDC.</ipd_description>
  </patient_data>
  <!-- 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/NCT03271710
org study id: CSP1121
nct id: NCT03271710
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with
      follow-up to 30 days to determine the acute safety, acute device performance and clinical
      performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic
      Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic
      Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA)
      and capture and removal of embolic material during angioplasty for the femoral, iliac,
      popliteal and profunda arteries.
The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with
      follow-up to 30 days to determine the acute safety, acute device performance and clinical
      performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic
      Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic
      Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA)
      and capture and removal of embolic material during angioplasty for the femoral, iliac,
      popliteal and profunda arteries.

      The Vanguard System has been designed to revascularize iliac and femoro-popliteal PAD while
      protecting against embolization at the same time. It is the first system in which the embolic
      protection filter is coupled on the same catheter as the angioplasty balloon for use in the
      lower extremities. Up to 130 patients will be enrolled into this study and followed for 30
      days after post-procedure. Adult patients with lifestyle-limiting claudication or rest pain
      (Rutherford categories 2 to 3) who meet all eligibility criteria will be approached for
      participation in the trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from MAE, defined as death, amputation and target vessel revascularization (TVR)
time frame: 30 days
description: Primary safety endpoint
measure: Procedural success
time frame: 24 hours or at discharge.
description: Defined as <50% residual stenosis without MAE (death, amputation or TVR)
measure: Technical Success
time frame: Index procedure
description: Technical success of the investigational device using questionnaire
measure: Ankle-Brachial Index (ABI)
time frame: Baseline, discharge and 30 days
description: Change in Ankle-Brachial Index from baseline, discharge and 30 days
measure: Rutherford-Becker
time frame: 30 days
description: Rutherford-Becker improvement greater than or equal to 1
measure: Histomorphometric analysis of embolic protection filter content
time frame: Day 0. Filter collected at end of index procedure.
description: Histomorphometric analysis of embolic protection filter content
arm group label: Peripheral balloon angioplasty
arm group type: Experimental
description: Peripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries with the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
intervention type: Device
intervention name: peripheral balloon angioplasty
description: Percutaneous transluminal angioplasty (PTA) of the lower extremities
arm group label: Peripheral balloon angioplasty
other name: percutaneous transluminal angioplasty (PTA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Zeller, Prof.
role: Principal Investigator
affiliation: Universitäts-Herzzentrum Freiburg
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Germany
responsible party type: Sponsor
mesh term: Atherosclerosis
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Intermittent Claudication
sharing ipd: No
ipd description: Site specific individual participant data is available to each research site via export from EDC.