500 Boylston Street, Boston, MA 02116 617-419-4700
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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).
Not yet recruiting
Ages:18 and older
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).
Trial ID: NCT01726257
Not Accepting Healthy Volunteers