Clinical Trial

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks

Study acronym: AAA-SHAPE
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-01-10; most recent amendment 2025-12-18.
Status change: Recruiting → Active, Not Recruiting 2022-09-13
Status change: Not Yet Recruiting → Recruiting 2020-08-19
Trial Details
NCT Number NCT04227054
Lead Sponsor Shape Memory Medical, Inc.
Conditions Abdominal Aortic Aneurysm
Enrollment 15 participants
Start Date 2020-09-09
Primary Completion 2023-08-30 (estimated)
Study Completion 2028-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-22