Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix®… (NCT01726257) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
United States333 participantsStarted 2013-12
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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 ≥5.0cm, 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 18 to 32mm; angle ≤60° to the aneurysm sac;
* Common iliac artery lumen diameter between 9 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).