Safety and Effectiveness Assessment of AneuFix Injectable Polymer Sac Filling to Assure Long-term Durability of EVAR. (SEAL-EVAR)

Inclusion Criteria:

• Age over 22 years

• Presence of an infrarenal AAA with a maximum diameter of at least 5 cm for women and 5.5 cm for men

• High risk of developing T2EL after the EVAR procedure, based on one or more of the following criteria observed on a preoperative CTA scan. High risk participants are those with:

  • A patent inferior mesenteric artery with a luminal diameter at its origin >3 mm OR
  • At least three pairs of patent lumbar arteries OR
  • Two pairs of lumbar arteries and a median sacral artery or an accessory renal artery

• Subject or legal caregiver's willingness and ability to comply with the requirements of this clinical study and provide written informed consent

Exclusion Criteria:

General

• Inability to provide informed consent.
• Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
• Unable or unwilling to comply with study follow-up requirements.
• Prisoner or member of other vulnerable population

Anatomical

• Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.
• Aorto-Iliac aneurysms
• Aneurysm sac requiring more than 100ml of AneuFix Injectable Polymer to fill
• Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.
• Connective tissue disorder (e.g., Marfan's syndrome)
• Aneurysmal disease of the descending thoracic aorta
• Proximal abdominal aneurysm extent including or above the renal arteries
• Calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties

Procedural

• Use of endograft without support struts in the bifurcation (e.g. Endologix - Alto)
• Use of an aortic stent graft other than those specified for a particular site
• Planned off-label use of the chosen stent graft
• Use of fenestrated stent grafts or chimney techniques
• Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries
• Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries, except when the internal iliac artery pre-procedure is already occluded.

Medical History/Conditions

• Coagulopathy or uncontrolled bleeding disorder
• 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
• Life expectancy of <2 years post-procedure
• Known hypersensitivity or other contraindication to tantalum
• Active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC>11,000/mm3)
• A condition that inhibits radiographic visualization during the implantation procedure
• History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CTA with contrast for any reason.
• Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial
• Pregnant or 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 trial.