Clinical Trial

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

Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-07-11
notable Primary completion pushed: 2027-06 -> 2027-07 2026-07-11
minor Completion pushed: 2031-06 -> 2031-07 2026-07-11
Trial Details
NCT Number NCT06029660
Lead Sponsor Shape Memory Medical, Inc.
Collaborators: NAMSA
Conditions Aortic Aneurysm, Abdominal
Enrollment 180 participants
Start Date 2024-04-05
Primary Completion 2027-07 (estimated)
Study Completion 2031-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-10