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
Parallel
IMPEDE-FX RapidFill Implants
DeviceFilling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants
EndoVascular Aneurysm Repair
Procedure/SurgeryStandard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.
Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days
Freedom from the following through 30 days post-index procedure: * Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss \>1000 mL. * AAA-rupture or AAA-perforation * Conversion to Open Repair
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Shape Memory Medical, Inc.
Lead sponsor
NAMSA
Collaborator
