Clinical Research Directory

Inclusion Criteria: * ≥18 years of age * A candidate for elective EVAR of an infrarenal aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women Exclusion Criteria: * An inability to provide informed consent * Enrolled in another clinical study * Aortoiliac aneurysm, or concomitant iliac artery ectasia or aneurysm (common iliac artery diameter \>24 mm) close to the bifurcation and/or that cannot be adequately sealed * Patent AAA sac feeding vessels (within the sac) \>4 mm in diameter * Volume of AAA sac to be filled after stent graft placement \<20 mL or \>135 mL, based on pre-procedure CTA (i.e. aortic flow volume exclusive of stent graft volume) * Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, or Medtronic Endurant II Stent Graft to treat the AAA * Planned use of the chosen stent graft outside its instructions for use (IFU) * Planned use of fenestrated or chimney stent grafts * Study participants in which stent graft placement is abandoned for any reason, and/or in which the investigator decides, during the course of the stent graft placement, that the study procedure may not be appropriate * Planned use of embolic devices other than the investigational product to embolize the AAA sac * Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac * Ruptured, leaking, or mycotic (infected) aneurysm * Aneurysmal disease of the descending thoracic aorta * Coagulopathy or uncontrolled bleeding disorder * Long-term (\>6 months prior to the procedure) use of direct oral anticoagulant or any vitamin K antagonist anticoagulant use * Serum creatinine level \>2.5 mg/dL; * Cerebrovascular accident within 3 months prior to the procedure * Myocardial infarction and/or major heart surgery within 3 months prior to the procedure * Atrial fibrillation that is not well rate controlled * Unable or unwilling to comply with study follow-up requirements * Life expectancy of \<2 years post-procedure * Known hypersensitivity or contraindication to platinum, iridium, or polyurethane * A condition that inhibits radiographic visualization during the implantation procedure * History of allergy to contrast medium that cannot be managed medically * Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study * Pregnant or a lactating female. For females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study * Prisoner or member of other vulnerable population.