Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT01726257
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 ≥5.0cm, 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01726257
Study Brief:
Protocol Section:
NCT01726257