Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study

To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.

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.