RecruitingAortic Aneurysm, Abdominal

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Eligible age

18+ yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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About this study

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.

Sponsor: Shape Memory Medical, Inc.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.