To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.
≥18 years of age
A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;
Thrombus burden (percentage of the AAA sac occupied by thrombus) <50%, based on pre-procedure CTA
Maximum Lumen diameter within the AAA sac of ≥40mm.
An 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
Shape Memory Medical, Inc.
Lead sponsor
NAMSA
Collaborator