๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-08

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion (NCT06029660)

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Shape Memory Medical, Inc.

๐Ÿฉบ 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

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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

๐Ÿ’ฐ 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—