Clinical Trial

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands

Study acronym: AAA-SHAPE_NLD
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 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-02-08; most recent amendment 2025-12-18.
Status change: Recruiting → Active, Not Recruiting 2022-05-26
Status change: Not Yet Recruiting → Recruiting 2021-08-26
Trial Details
NCT Number NCT04751578
Lead Sponsor Shape Memory Medical, Inc.
Conditions Abdominal Aortic Aneurysm
Enrollment 15 participants
Start Date 2021-07-13
Primary Completion 2022-04-13 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-22