AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years of age 2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women; 3. Thrombus burden (percentage of the AAA sac occupied by thrombus) \<50%, based on pre-procedure CTA 4. Maximum Lumen diameter within the AAA sac of ≥40mm. 5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200. Exclusion Criteria: General 1. An inability to provide informed consent. 2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial. 3. Unable or unwilling to comply with study follow-up requirements. 4. Prisoner or member of other vulnerable population Anatomical 1. Concomitant iliac artery ectasia or aneurysm 2. Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac. 3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm. 4. Connectiv