Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System (EVAS IDE)

Trial Purpose and Description

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).

Ages: 18 years and older

Gender: Both

Eligibility Criteria

Inclusion Criteria:

  • Male or female at least 18 years old;
  • Informed consent understood and signed;
  • Patient agrees to all follow-up visits;
  • Have AAA with sac diameter ≥5.5cm, or ≥4.5 cm which has increased by >1.0cm in the past year.
  • Anatomic eligibility for the Nellix System per the instructions for use:
  • Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
  • Aneurysm blood lumen diameter ≤60mm;
  • Most caudal renal artery to aortoiliac bifurcation length ≥100mm;
  • Proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 16 to 32mm; angle ≤60° to the aneurysm sac;
  • Common iliac artery lumen diameter between 8 and 35mm with blood lumen diameter ≤35mm;
  • Ability to preserve at least one hypogastric artery.

Exclusion Criteria:

  • Life expectancy <2 years;
  • Psychiatric or other condition that may interfere with the study;
  • Participating in enrollment of another clinical study
  • Known allergy to device any device component;
  • Coagulopathy or uncontrolled bleeding disorder;
  • Ruptured, leaking or mycotic aneurysm;
  • Serum creatinine level >2.0mg/dL;
  • CVA or MI within three months of enrollment/treatment;
  • Aneurysmal disease of the descending thoracic aorta;
  • Clinically significant infrarenal mural thrombus (>5mm thickness over >50% circumference);
  • Connective tissue diseases (e.g., Marfan Syndrome)
  • Unsuitable vascular anatomy;
  • Pregnant (females of childbearing potential only).

Endologix, Inc.

Dates: 05/12/2014 - 09/30/2019

Last Updated: 06/24/2015

Study HIC#: 1310012916

Get Involved

For more information about this study, contact:
Patricia Fugal
+1 203-785-4855

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email or call 1-877-978-8348.

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