<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/NCT03298477</url>
  </required_header>
  <id_info>
    <org_study_id>CP-0008 EVAS2 IDE</org_study_id>
    <nct_id>NCT03298477</nct_id>
  </id_info>
  <brief_title>EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study</brief_title>
  <acronym>EVAS2</acronym>
  <official_title>Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endologix</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endologix</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at&#xD;
      each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the&#xD;
      Nellix System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the safety and effectiveness of the Nellix System among a wide range&#xD;
      of physicians and in consecutively enrolled subjects to assess safety and effectiveness&#xD;
      outcomes. Following appropriate government and ethics committee/IRB approval the Nellix®&#xD;
      EndoVascular Sealing System will be implanted into eligible patients who are adequately&#xD;
      informed and have consented to join the study. Enrolled patients will undergo a high&#xD;
      resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant&#xD;
      aortic and aortoiliac vasculature within three months of the scheduled procedure and at&#xD;
      specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6&#xD;
      months, and annually to 5 years to assess aneurysm morphology, the status of the implanted&#xD;
      devices, and relevant laboratory test results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">August 16, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 17, 2022</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>
    <intervention_model_description>Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. Sites have been chosen with a suitable research infrastructure and physician experience in endovascular aneurysm repair to ensure adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Major Adverse Events (MAE)</measure>
    <time_frame>30 days</time_frame>
    <description>All cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss &gt;1,000cc</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Treatment Success</measure>
    <time_frame>1 year</time_frame>
    <description>Procedural technical success and the absence of aneurysm rupture, conversion to open surgical repair, Type I endoleak at 12 months, Type III endoleak at 12 months, aneurysm enlargement, secondary procedure for resolution of endoleak (Type I or III), limb occlusion, migration, aneurysm sac expansion and/or a device defect</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Abdominal Aortic Aneurysm Without Rupture</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nellix® System</intervention_name>
    <description>Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
        A patient who meets all of the following criteria potentially may be included in the study:&#xD;
&#xD;
          1. Male or female at least 18 years old;&#xD;
&#xD;
          2. Informed consent form understood and signed&#xD;
&#xD;
          3. Patient agrees to all follow-up visits;&#xD;
&#xD;
          4. Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by&#xD;
             ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse&#xD;
             dimension of an adjacent non-aneurysmal aortic segment. No AAA &lt;4 cm will be included.&#xD;
&#xD;
          5. Anatomically eligible for the Nellix System (per Instructions For Use):&#xD;
&#xD;
               1. Adequate iliac/femoral access compatible with the required delivery systems&#xD;
                  (diameter ≥6 mm);&#xD;
&#xD;
               2. Aneurysm blood lumen diameter ≤60mm;&#xD;
&#xD;
               3. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle&#xD;
                  ≤60° to the aneurysm sac;&#xD;
&#xD;
               4. Most caudal renal artery to each hypogastric artery length ≥100mm;&#xD;
&#xD;
               5. Common iliac artery lumen diameter between 9 and 35mm;&#xD;
&#xD;
               6. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to&#xD;
                  25mm;&#xD;
&#xD;
               7. Ability to preserve at least one hypogastric artery.&#xD;
&#xD;
               8. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter&#xD;
                  &lt;1.40&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
        A patient who meets none of the following criteria potentially may be included in the&#xD;
        study:&#xD;
&#xD;
          1. Life expectancy &lt;2 years as judged by the Investigator;&#xD;
&#xD;
          2. Psychiatric or other condition that may interfere with the study;&#xD;
&#xD;
          3. Participating in another clinical study;&#xD;
&#xD;
          4. Known allergy or contraindication to any device material;&#xD;
&#xD;
          5. Coagulopathy or uncontrolled bleeding disorder;&#xD;
&#xD;
          6. Ruptured, leaking or mycotic aneurysm;&#xD;
&#xD;
          7. Serum creatinine (S-Cr) level &gt;2.0 mg/dL;&#xD;
&#xD;
          8. CVA or MI within three months of enrollment/treatment;&#xD;
&#xD;
          9. Aneurysmal disease of the descending thoracic aorta;&#xD;
&#xD;
         10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm)&#xD;
             of the infrarenal non-aneurysmal neck (&gt;5mm thickness over &gt;50% circumference);&#xD;
&#xD;
         11. Connective tissue diseases (e.g., Marfan Syndrome);&#xD;
&#xD;
         12. Unsuitable vascular anatomy that may interfere with device introduction or deployment;&#xD;
&#xD;
         13. Pregnant (female 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>Jeffrey Carpenter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cooper Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Valley Vascular Consultants</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regents of the University of California (UCLA)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Medical Research Foundation</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Health-Memorial Hospital</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Health Research Institute</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Cardiac &amp; Vascular Institute (MCVI)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Vascular &amp; Interventional</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Clinic</name>
      <address>
        <city>Champaign</city>
        <state>Illinois</state>
        <zip>61820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMITA Health</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Heart Center of Indiana</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLaren Bay Region</name>
      <address>
        <city>Bay City</city>
        <state>Michigan</state>
        <zip>48708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Aortic &amp; Vascular Institute</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cooper Health System</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Heart Institute</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Ohio Vascular Assoc (NEOVA)</name>
      <address>
        <city>Willoughby</city>
        <state>Ohio</state>
        <zip>44095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OU College of Medicine</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence St. Vincent Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Health- University of South Carolina</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellmont CVA Heart Institute</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Surgery Clinic</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Research Center</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart Medical Center</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus Research Institute</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>54401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</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>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03298477
org study id: CP-0008 EVAS2 IDE
nct id: NCT03298477
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at
      each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the
      Nellix System.
This study will evaluate the safety and effectiveness of the Nellix System among a wide range
      of physicians and in consecutively enrolled subjects to assess safety and effectiveness
      outcomes. Following appropriate government and ethics committee/IRB approval the Nellix®
      EndoVascular Sealing System will be implanted into eligible patients who are adequately
      informed and have consented to join the study. Enrolled patients will undergo a high
      resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant
      aortic and aortoiliac vasculature within three months of the scheduled procedure and at
      specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6
      months, and annually to 5 years to assess aneurysm morphology, the status of the implanted
      devices, and relevant laboratory test results.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. Sites have been chosen with a suitable research infrastructure and physician experience in endovascular aneurysm repair to ensure adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Major Adverse Events (MAE)
time frame: 30 days
description: All cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1,000cc
measure: Rate of Treatment Success
time frame: 1 year
description: Procedural technical success and the absence of aneurysm rupture, conversion to open surgical repair, Type I endoleak at 12 months, Type III endoleak at 12 months, aneurysm enlargement, secondary procedure for resolution of endoleak (Type I or III), limb occlusion, migration, aneurysm sac expansion and/or a device defect
arm group label: Single Arm
arm group type: Other
description: Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System
intervention type: Device
intervention name: Nellix® System
description: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
arm group label: Single Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey Carpenter, MD
role: Principal Investigator
affiliation: Cooper Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
mesh term: Rupture
sharing ipd: No