AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Active, not recruiting · Not applicable · NCT06029660
Conditions: Aortic Aneurysm, Abdominal
At a glance
- Research payments reported, 2025
- $41,888
- U.S. investigators named
- 3
- Sites paid
- 3
- Planned or actual enrollment
- 180
About the trial
- Sponsor
- Shape Memory Medical, Inc. (with NAMSA)
- Tested
- IMPEDE-FX RapidFill Implants (device), EndoVascular Aneurysm Repair (procedure)
- Dates
- Started 2024-04-05; completion 2031-07
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-07-10. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Shape Memory Medical Inc. reported $41,888 in research payments for this study in 2025 (5 payments).
Products named: Impede-Fx Embolization Plug
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Raghunandan L. Motaganahalli Vascular Surgery · Bloomington, IN
- Eanas S. Yassa, M.D. Vascular Surgery · Grand Rapids, MI
- Virendra I. Patel, MD MPH Vascular Surgery · New York, NY
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- The Trustees of Columbia University in The City of New York $38,919
- Indiana University DBA Trustees of Indiana University $2,219
- Spectrum Health $750
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.