<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/NCT02996396</url>
  </required_header>
  <id_info>
    <org_study_id>CP0010 Ver. 2</org_study_id>
    <nct_id>NCT02996396</nct_id>
  </id_info>
  <brief_title>Nellix Registry Study: EVAS-Global</brief_title>
  <acronym>EVAS FORWARD 2</acronym>
  <official_title>Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endologix</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endologix</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter, single arm, open label, registry study with consecutive, eligible patient&#xD;
      enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System&#xD;
      (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as&#xD;
      per institutional standard of care thereafter through to 5 years (total follow-up commitment)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 21, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>60 Months</target_duration>
  <primary_outcome>
    <measure>Number of subjects with Immediate Procedural Technical Success</measure>
    <time_frame>30 Days</time_frame>
    <description>Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs)</measure>
    <time_frame>30 Days</time_frame>
    <description>Safety endpoint is measured with the number of subjects who are reported freedome of major adverse events (MAEs) including (1) all-cause death, (2) bowel ischemia, (3) myocardial infarction, (4) paraplegia, (5) renal failure, (6) respiratory failure, (7) stroke, and (8) Blood Loss &gt; 1000mL at 30 Days post index procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with Aneurysm rupture</measure>
    <time_frame>5 years</time_frame>
    <description>The number of patients experiencing a rupture of the aneurysm will be summarized at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with Conversion to open surgical repair</measure>
    <time_frame>5 years</time_frame>
    <description>The number of patients undergoing surgical conversion to open repair will be provided at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with Endoleak of any type</measure>
    <time_frame>5 years</time_frame>
    <description>The number of patients with any endoleak, and patients with each endoleak type at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5) will be summarized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with Clinically significant migration</measure>
    <time_frame>5 years</time_frame>
    <description>The number of patients with clinically significant migration will be summarized descriptively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with Aneurysm enlargement</measure>
    <time_frame>5 years</time_frame>
    <description>The number of patients with Aneurysm enlargement will be summarized descriptively. Sac enlargement is defined in the protocol as increase in late follow-up compared to the initial post-op measurement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of incidence with Secondary endovascular procedures</measure>
    <time_frame>5 years</time_frame>
    <description>The overall secondary procedure incidence and the individual component incidence will be provided.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Number of subjects with incidence of device patency and integrity</measure>
    <time_frame>5 years</time_frame>
    <description>Device patency and integrity will be measured by the number and proportion of patients at 30 days, 6 months, and 1 year to 5 years including Stent Kinking, Lumen Occlusion, and Stent Fracture.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of incidence with Distal Complications</measure>
    <time_frame>5 years</time_frame>
    <description>The number of incidence of distal thrombosis, embolization and iliac stenosis will be summarized.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Abdominal Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>Patients diagnosed with AAA who are considered candidates for Endovascular Repair and meet the study eligibility criteria and sign the Informed consent may be subsequently enrolled in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nellix Endovascular Aneurysm Sealing System (Nellix®-System)</intervention_name>
    <description>The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.</description>
    <arm_group_label>1</arm_group_label>
    <other_name>Nellix EVAS FORWARD 2</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with AAA who are considered candidates for Endovascular Repair and meet&#xD;
        the study eligibility criteria and sign the Informed consent may be subsequently enrolled&#xD;
        in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female at least 18 years old&#xD;
&#xD;
          2. Subject has signed informed consent for data release&#xD;
&#xD;
          3. Subjects with with AAA and eligible for endovascular repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently participating in another study where primary endpoint has not been reached&#xD;
             yet&#xD;
&#xD;
          2. Known allergy to any of the device components&#xD;
&#xD;
          3. Pregnant (females of childbearing potential only)&#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>Andrew Holden, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Auckland City Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michel Reijnen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rijnstate, Arnhem, the Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Augsburg Klinik für Gefäßchirurgie</name>
      <address>
        <city>Augsburg</city>
        <zip>86156</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Marien Hospital Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Koeln</name>
      <address>
        <city>Koeln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TUM Munich</name>
      <address>
        <city>Munich</city>
        <zip>80333</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <zip>90</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Elisabeth Ziekenhuis, Dept of Vascular Surgery</name>
      <address>
        <city>Tilburg</city>
        <zip>5022 GC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politécnico de La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>June 6, 2022</last_update_submitted>
  <last_update_submitted_qc>June 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AAA, Aortoiliac Aneurysm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</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/NCT02996396
org study id: CP0010 Ver. 2
nct id: NCT02996396
lead sponsor: 
has dmc: No
Multicenter, single arm, open label, registry study with consecutive, eligible patient
      enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System
      (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as
      per institutional standard of care thereafter through to 5 years (total follow-up commitment)
observational model: Cohort
time perspective: Prospective
measure: Number of subjects with Immediate Procedural Technical Success
time frame: 30 Days
description: Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.
measure: Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs)
time frame: 30 Days
description: Safety endpoint is measured with the number of subjects who are reported freedome of major adverse events (MAEs) including (1) all-cause death, (2) bowel ischemia, (3) myocardial infarction, (4) paraplegia, (5) renal failure, (6) respiratory failure, (7) stroke, and (8) Blood Loss > 1000mL at 30 Days post index procedure.
measure: Number of subjects with Aneurysm rupture
time frame: 5 years
description: The number of patients experiencing a rupture of the aneurysm will be summarized at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).
measure: Number of subjects with Conversion to open surgical repair
time frame: 5 years
description: The number of patients undergoing surgical conversion to open repair will be provided at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).
measure: Number of subjects with Endoleak of any type
time frame: 5 years
description: The number of patients with any endoleak, and patients with each endoleak type at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5) will be summarized.
measure: Number of subjects with Clinically significant migration
time frame: 5 years
description: The number of patients with clinically significant migration will be summarized descriptively.
measure: Number of subjects with Aneurysm enlargement
time frame: 5 years
description: The number of patients with Aneurysm enlargement will be summarized descriptively. Sac enlargement is defined in the protocol as increase in late follow-up compared to the initial post-op measurement.
measure: Number of incidence with Secondary endovascular procedures
time frame: 5 years
description: The overall secondary procedure incidence and the individual component incidence will be provided.
measure: Number of subjects with incidence of device patency and integrity
time frame: 5 years
description: Device patency and integrity will be measured by the number and proportion of patients at 30 days, 6 months, and 1 year to 5 years including Stent Kinking, Lumen Occlusion, and Stent Fracture.
measure: Number of incidence with Distal Complications
time frame: 5 years
description: The number of incidence of distal thrombosis, embolization and iliac stenosis will be summarized.
arm group label: 1
description: Patients diagnosed with AAA who are considered candidates for Endovascular Repair and meet the study eligibility criteria and sign the Informed consent may be subsequently enrolled in the study.
intervention type: Device
intervention name: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
description: The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.
arm group label: 1
other name: Nellix EVAS FORWARD 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Holden, MBChB
role: Principal Investigator
affiliation: Auckland City Hospital
last name: Michel Reijnen, MD
role: Principal Investigator
affiliation: Rijnstate, Arnhem, the Netherlands
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Netherlands
country: New Zealand
country: Spain
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal