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.
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Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
Timeframe: 1 year
Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days
Timeframe: 30 days