<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/NCT02209194</url>
  </required_header>
  <id_info>
    <org_study_id>PLIANT</org_study_id>
    <nct_id>NCT02209194</nct_id>
  </id_info>
  <brief_title>Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System</brief_title>
  <official_title>PLIANT - A Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With a New Generation of Low Profile E-liac Stent Graft System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JOTEC GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>JOTEC GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the clinical and technical success as well as safety&#xD;
      and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or&#xD;
      bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with&#xD;
      primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac&#xD;
      implantation side.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary patency</measure>
    <time_frame>within 30 days</time_frame>
    <description>Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Patency</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary patency</measure>
    <time_frame>36 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Endoleak Type I or III</measure>
    <time_frame>within 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Endoleak Type I or III</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Endoleak Type I or III</measure>
    <time_frame>36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in aneurysm size</measure>
    <time_frame>within 30 days (baseline) and 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent graft migration</measure>
    <time_frame>within 30 days (baseline) and 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent graft dislodgement</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent graft kinking</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distal embolization</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of death</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complications</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">47</enrollment>
  <condition>Iliac Aneurysm</condition>
  <arm_group>
    <arm_group_label>Aortoiliac Aneurysms Iliac Aneurysms</arm_group_label>
    <description>Endovascular repair of aortoiliac or iliac aneurysms</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>E-liac Stent Graft System</intervention_name>
    <description>Implantation of the E-liac Stent Graft System in combination with a peripheral covered stent and in case of aortoiliac aneurysm in combination with a AAA Stent Graft</description>
    <arm_group_label>Aortoiliac Aneurysms Iliac Aneurysms</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with uni- or bilateral aortoiliac or common iliac aneurysm&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must comply with the indications for use&#xD;
&#xD;
          -  Unilateral or bilateral common iliac aneurysm diameter equal or greater 25mm&#xD;
&#xD;
          -  Unsuitable distal sealing site within the common iliac artery for traditional EVAR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a stenotic internal iliac ostium of &lt; 4mm in diameter&#xD;
&#xD;
          -  Patients with severe internal iliac atherosclerosis&#xD;
&#xD;
          -  Patients that do not have a suitable landing area in the main stem of the IIA&#xD;
&#xD;
          -  Patients with pseudoaneurysms&#xD;
&#xD;
          -  Patients with symptomatic and ruptured iliac aneurysms&#xD;
&#xD;
          -  Patients with one of the contraindications as indicated in the instructions for use&#xD;
&#xD;
          -  Patients pretreated with a bifurcated vascular graft&#xD;
&#xD;
          -  Patient with thrombocytopenia&#xD;
&#xD;
          -  Patient with creatinine &gt;2.4 mg/dl immediately before the intervention&#xD;
&#xD;
          -  Patient with malignancy needing chemotherapy or radiation&#xD;
&#xD;
          -  Patients who are enrolled in another clinical study&#xD;
&#xD;
          -  Patients with life expectancy of less than 36 months&#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>Jan Brunkwall, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cologne University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herzzentrum Hietzing</name>
      <address>
        <city>Wien</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital</name>
      <address>
        <city>Wien</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>German Heart Center</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz</name>
      <address>
        <city>Chemnitz</city>
        <zip>09113</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cologne University Hospital</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinikum Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKSH Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Leonberg</name>
      <address>
        <city>Leonberg</city>
        <zip>71229</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marienhospital</name>
      <address>
        <city>Osnabrück</city>
        <zip>49074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Hematologii i Transfuzjologii</name>
      <address>
        <city>Warszawa</city>
        <zip>02-776</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Donostia</name>
      <address>
        <city>San Sebastian</city>
        <zip>20080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Poland</country>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Brunkwall JS, Vaquero-Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Calavia AR, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results. Eur J Vasc Endovasc Surg. 2019 Dec;58(6):831-838. doi: 10.1016/j.ejvs.2019.06.020. Epub 2019 Oct 12.</citation>
    <PMID>31615695</PMID>
  </reference>
  <reference>
    <citation>Brunkwall J, Vaquero Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Revilla Calavia A, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results. Vascular. 2018 Dec;26(6):647-656. doi: 10.1177/1708538118789510. Epub 2018 Jul 23.</citation>
    <PMID>30037302</PMID>
  </reference>
  <reference>
    <citation>Anton S, Wiedner M, Stahlberg E, Jacob F, Barkhausen J, Goltz JP. Initial Experience with the E-liac(R) Iliac Branch Device for the Endovascular Aortic Repair of Aorto-iliac Aneurysm. Cardiovasc Intervent Radiol. 2018 May;41(5):683-691. doi: 10.1007/s00270-017-1868-x. Epub 2018 Jan 3.</citation>
    <PMID>29299625</PMID>
  </reference>
  <reference>
    <citation>Mylonas SN, Rumenapf G, Schelzig H, Heckenkamp J, Youssef M, Schafer JP, Ahmad W, Brunkwall JS; E-liac Collaborative Group. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg. 2016 Dec;64(6):1652-1659.e1. doi: 10.1016/j.jvs.2016.04.065. Epub 2016 Aug 1.</citation>
    <PMID>27492764</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>April 29, 2020</last_update_submitted>
  <last_update_submitted_qc>April 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aneurysms</keyword>
  <keyword>vascular disease</keyword>
  <keyword>E-liac Stent Graft</keyword>
  <keyword>E-liac Stent Graft System</keyword>
  <keyword>iliac aneurysm</keyword>
  <keyword>branched stent graft</keyword>
  <keyword>self expanding stent graft</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Iliac Aneurysm</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/NCT02209194
org study id: PLIANT
nct id: NCT02209194
lead sponsor: 
has dmc: No
The purpose of the study is to evaluate the clinical and technical success as well as safety
      and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or
      bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with
      primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac
      implantation side.
observational model: Cohort
time perspective: Prospective
measure: Primary patency
time frame: within 30 days
description: Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side
measure: Primary Patency
time frame: 12 months
measure: Primary patency
time frame: 36 months
measure: Endoleak Type I or III
time frame: within 30 days
measure: Endoleak Type I or III
time frame: 12 months
measure: Endoleak Type I or III
time frame: 36 months
measure: Change in aneurysm size
time frame: within 30 days (baseline) and 36 months
measure: Stent graft migration
time frame: within 30 days (baseline) and 36 months
measure: Stent graft dislodgement
time frame: 36 months
measure: Stent graft kinking
time frame: 36 months
measure: Distal embolization
time frame: 36 months
measure: Rate of death
time frame: 36 months
measure: Rate of complications
time frame: 36 months
arm group label: Aortoiliac Aneurysms Iliac Aneurysms
description: Endovascular repair of aortoiliac or iliac aneurysms
intervention type: Device
intervention name: E-liac Stent Graft System
description: Implantation of the E-liac Stent Graft System in combination with a peripheral covered stent and in case of aortoiliac aneurysm in combination with a AAA Stent Graft
arm group label: Aortoiliac Aneurysms Iliac Aneurysms
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Brunkwall, Professor
role: Principal Investigator
affiliation: Cologne University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Germany
country: Poland
country: Spain
citation: Brunkwall JS, Vaquero-Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Calavia AR, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results. Eur J Vasc Endovasc Surg. 2019 Dec;58(6):831-838. doi: 10.1016/j.ejvs.2019.06.020. Epub 2019 Oct 12.
PMID: 31615695
citation: Brunkwall J, Vaquero Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Revilla Calavia A, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results. Vascular. 2018 Dec;26(6):647-656. doi: 10.1177/1708538118789510. Epub 2018 Jul 23.
PMID: 30037302
citation: Anton S, Wiedner M, Stahlberg E, Jacob F, Barkhausen J, Goltz JP. Initial Experience with the E-liac(R) Iliac Branch Device for the Endovascular Aortic Repair of Aorto-iliac Aneurysm. Cardiovasc Intervent Radiol. 2018 May;41(5):683-691. doi: 10.1007/s00270-017-1868-x. Epub 2018 Jan 3.
PMID: 29299625
citation: Mylonas SN, Rumenapf G, Schelzig H, Heckenkamp J, Youssef M, Schafer JP, Ahmad W, Brunkwall JS; E-liac Collaborative Group. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg. 2016 Dec;64(6):1652-1659.e1. doi: 10.1016/j.jvs.2016.04.065. Epub 2016 Aug 1.
PMID: 27492764
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Iliac Aneurysm