<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/NCT01726257</url>
  </required_header>
  <id_info>
    <org_study_id>CP-0008</org_study_id>
    <nct_id>NCT01726257</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System</brief_title>
  <acronym>EVAS IDE</acronym>
  <official_title>Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access 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>
      The objective of this study is to assess the safety and effectiveness of the Endologix&#xD;
      Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).&#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 outcomes generalizability.&#xD;
      Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular&#xD;
      Sealing System will be implanted into eligible patients who are adequately informed and have&#xD;
      consented to join the study. Enrolled patients will undergo a high resolution,&#xD;
      contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and&#xD;
      aortoiliac vasculature within three months of the scheduled procedure and at specified&#xD;
      follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and&#xD;
      annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and&#xD;
      relevant laboratory test results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2013</start_date>
  <completion_date type="Actual">December 2022</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Major Adverse Events at 30 Days</measure>
    <time_frame>30 days</time_frame>
    <description>Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss &gt;1,000cc</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Success at 1 Year</measure>
    <time_frame>1 year</time_frame>
    <description>Treatment Success = 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>
  <secondary_outcome>
    <measure>Major Adverse Events From 30 days to 5 years</measure>
    <time_frame>&gt;30 days to 5 years</time_frame>
    <description>Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss &gt;1,000cc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Utility Outcomes</measure>
    <time_frame>At the time of procedure</time_frame>
    <description>anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in ICU</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Number of hours spent in the intensive care unit (ICU)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>&gt; 30 days to 5 years</time_frame>
    <description>All serious and non-serious events within 30 days, at 6 months, and at 1 to 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm Rupture</measure>
    <time_frame>&gt; 30 days to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conversion to Open-Surgical Repair</measure>
    <time_frame>&gt;30 days to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Performance</measure>
    <time_frame>&gt; 30 days to 5 years</time_frame>
    <description>aneurysm sac diameter change from the first post-operative CT scan, device migration, device patency, device integrity, incidence of endoleak</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>&gt; 30 days to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Dysfunction</measure>
    <time_frame>Post-procedure to 5 years</time_frame>
    <description>assessment of estimated glomerular filtration rate (eGFR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Surgical Intervention</measure>
    <time_frame>Post-procedure to 5 years</time_frame>
    <description>The number of additional surgical procedures to repair resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defects will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Hospital Discharge</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Number of days spent in hospital</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">333</enrollment>
  <condition>Abdominal Aortic Aneurysm (AAA)</condition>
  <arm_group>
    <arm_group_label>Nellix System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nellix System</intervention_name>
    <description>Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.</description>
    <arm_group_label>Nellix System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female at least 18 years old;&#xD;
&#xD;
          -  Informed consent understood and signed;&#xD;
&#xD;
          -  Patient agrees to all follow-up visits;&#xD;
&#xD;
          -  Have AAA with sac diameter ≥5.0cm, or ≥4.5 cm which has increased by &gt;1.0cm in the&#xD;
             past year.&#xD;
&#xD;
          -  Anatomic eligibility for the Nellix System per the instructions for use:&#xD;
&#xD;
          -  Adequate iliac/femoral access compatible with the required delivery systems (diameter&#xD;
             ≥6 mm);&#xD;
&#xD;
          -  Aneurysm blood lumen diameter ≤60mm;&#xD;
&#xD;
          -  Most caudal renal artery to aortoiliac bifurcation length ≥100mm;&#xD;
&#xD;
          -  Proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 18 to 32mm; angle&#xD;
             ≤60° to the aneurysm sac;&#xD;
&#xD;
          -  Common iliac artery lumen diameter between 9 and 35mm with blood lumen diameter ≤35mm;&#xD;
&#xD;
          -  Ability to preserve at least one hypogastric artery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy &lt;2 years;&#xD;
&#xD;
          -  Psychiatric or other condition that may interfere with the study;&#xD;
&#xD;
          -  Participating in enrollment of another clinical study&#xD;
&#xD;
          -  Known allergy to device any device component;&#xD;
&#xD;
          -  Coagulopathy or uncontrolled bleeding disorder;&#xD;
&#xD;
          -  Ruptured, leaking or mycotic aneurysm;&#xD;
&#xD;
          -  Serum creatinine level &gt;2.0mg/dL;&#xD;
&#xD;
          -  CVA or MI within three months of enrollment/treatment;&#xD;
&#xD;
          -  Aneurysmal disease of the descending thoracic aorta;&#xD;
&#xD;
          -  Clinically significant infrarenal mural thrombus (&gt;5mm thickness over &gt;50%&#xD;
             circumference);&#xD;
&#xD;
          -  Connective tissue diseases (e.g., Marfan Syndrome)&#xD;
&#xD;
          -  Unsuitable vascular anatomy;&#xD;
&#xD;
          -  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>Jeffrey Carpenter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cooper Hospital, Camden, NJ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tucson Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06437</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Hospital</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</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>Baptist Hospital of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacred Heart</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</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>46077</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth's Medical Center</name>
      <address>
        <city>Brighton</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay State Hospital</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Heart and Vascular Center of Montana</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Heart Institute</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper Hospital</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Health Care</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</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>Ohio Health Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Heart and Vascular Institue</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Hospital Baylor Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott &amp; White Healthcare System</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</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>Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Württemberg</state>
        <zip>D-69120</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>Addenbrooke's Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
    <country>France</country>
  </removed_countries>
  <reference>
    <citation>Kisis K, Krievins D, Naskovica K, Gedins M, Savlovskis J, Ezite N, Lietuvietis E, Zarins K. Quality of life after endovascular abdominal aortic aneurysm repair: nellix sac-anchoring endoprosthesis versus open surgery. Medicina (Kaunas). 2012;48(6):286-91.</citation>
    <PMID>22885361</PMID>
  </reference>
  <reference>
    <citation>Krievins DK, Holden A, Savlovskis J, Calderas C, Donayre CE, Moll FL, Katzen B, Zarins CK. EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):38-46. doi: 10.1016/j.ejvs.2011.03.007. Epub 2011 Apr 15.</citation>
    <PMID>21497521</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <disposition_first_submitted>April 30, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>May 5, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 10, 2021</disposition_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infrarenal</keyword>
  <keyword>Abdominal</keyword>
  <keyword>Aortic</keyword>
  <keyword>Aneurysm</keyword>
  <keyword>AAA</keyword>
  <keyword>Endologix</keyword>
  <keyword>EVAS</keyword>
  <keyword>EndoVascular</keyword>
  <keyword>Sealing</keyword>
  <keyword>System</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, but a results disposition has been submitted           -->
</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/NCT01726257
org study id: CP-0008
nct id: NCT01726257
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The objective of this study is to assess the safety and effectiveness of the Endologix
      Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).
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 outcomes generalizability.
      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
primary purpose: Treatment
masking: None (Open Label)
measure: Major Adverse Events at 30 Days
time frame: 30 days
description: Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
measure: Treatment Success at 1 Year
time frame: 1 year
description: Treatment Success = 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.
measure: Major Adverse Events From 30 days to 5 years
time frame: >30 days to 5 years
description: Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
measure: Clinical Utility Outcomes
time frame: At the time of procedure
description: anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time
measure: Time in ICU
time frame: Up to 7 days
description: Number of hours spent in the intensive care unit (ICU)
measure: Adverse Events
time frame: > 30 days to 5 years
description: All serious and non-serious events within 30 days, at 6 months, and at 1 to 5 years
measure: Aneurysm Rupture
time frame: > 30 days to 5 years
measure: Conversion to Open-Surgical Repair
time frame: >30 days to 5 years
measure: Device Performance
time frame: > 30 days to 5 years
description: aneurysm sac diameter change from the first post-operative CT scan, device migration, device patency, device integrity, incidence of endoleak
measure: Mortality
time frame: > 30 days to 5 years
measure: Renal Dysfunction
time frame: Post-procedure to 5 years
description: assessment of estimated glomerular filtration rate (eGFR)
measure: Secondary Surgical Intervention
time frame: Post-procedure to 5 years
description: The number of additional surgical procedures to repair resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defects will be collected.
measure: Time to Hospital Discharge
time frame: Up to 7 days
description: Number of days spent in hospital
arm group label: Nellix System
arm group type: Experimental
description: Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.
intervention type: Device
intervention name: Nellix System
description: Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.
arm group label: Nellix System
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, Camden, NJ
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: 
facility: 
facility: 
facility: 
country: Germany
country: Netherlands
country: United Kingdom
country: United States
country: Canada
country: France
citation: Kisis K, Krievins D, Naskovica K, Gedins M, Savlovskis J, Ezite N, Lietuvietis E, Zarins K. Quality of life after endovascular abdominal aortic aneurysm repair: nellix sac-anchoring endoprosthesis versus open surgery. Medicina (Kaunas). 2012;48(6):286-91.
PMID: 22885361
citation: Krievins DK, Holden A, Savlovskis J, Calderas C, Donayre CE, Moll FL, Katzen B, Zarins CK. EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):38-46. doi: 10.1016/j.ejvs.2011.03.007. Epub 2011 Apr 15.
PMID: 21497521
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal