๐๏ธ Verified NIH Record โข Updated 2026-07-08
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion (NCT06029660)
๐ต Active, Not Recruiting Observational / Diagnostic โ๏ธ Medical Device Protocol Sponsor: Shape Memory Medical, Inc.
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama Birmingham โ Birmingham, Alabama
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (49 Sites)
Showing the first 25 of 49 sites.
- University of Alabama Birmingham โ Birmingham, Alabama
- Honor Health โ Scottsdale, Arizona
- USC Keck โ Los Angeles, California
- San Diego VA Medical Center โ San Diego, California
- Delray Medical Center โ Delray Beach, Florida
- Mt. Sinai Medical Center โ Miami Beach, Florida
- Orlando Health โ Orlando, Florida
- University of South Florida โ Tampa, Florida
- Emory University Hospital โ Atlanta, Georgia
- University of Chicago โ Chicago, Illinois
- Indiana University โ Indianapolis, Indiana
- Maine Medical โ Portland, Maine
- Johns Hopkins โ Baltimore, Maryland
- Massachusetts General Hospital โ Boston, Massachusetts
- Brigham & Women's Hospital โ Boston, Massachusetts
- Beth Israel Deaconess Medical Center โ Boston, Massachusetts
- VA Ann Arbor Healthcare โ Ann Arbor, Michigan
- Corewell Health โ Grand Rapids, Michigan
- Mayo Clinic โ Rochester, Minnesota
- Dartmouth Hitchcock Medical Center โ Lebanon, New Hampshire
- University at Buffalo โ Buffalo, New York
- Buffalo VA Western New York โ Buffalo, New York
- NYU Langone โ New York, New York
- Columbia University Irving Medical Center/New York Presbyterian Hospital โ New York, New York
- University of Rochester โ Rochester, New York
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Aortic Aneurysm, Abdominal
- Assessment of the GOREยฎ EXCLUDERยฎ Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms โ Birmingham, Alabama
- Clinical Outcomes of Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms โ Rochester, Minnesota
- Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck โ Washington, Arkansas
- ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES โ La Jolla, California
- Zenithยฎ Fenestrated+ Clinical Study โ Birmingham, Alabama
Explore by condition: All Aortic Aneurysm, Abdominal clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.