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
- 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.
- 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).
Dates: 05/12/2014 - 09/30/2019
Last Updated: 06/24/2015
Study HIC#: 1310012916