New implant aims to shrink deadly belly aneurysms and prevent rupture

NCT ID NCT06029660

Ongoing Disease control Sponsor: Shape Memory Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether adding a special implant (IMPEDE-FX RapidFill) during standard aneurysm repair helps shrink the aneurysm sac more effectively. About 180 adults with large abdominal aortic aneurysms will receive the implant alongside their usual stent graft. The goal is to see if the sac shrinks by at least 10% within a year, without major complications.

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AORTIC ANEURYSM, ABDOMINAL

Contacts and locations

Locations

Amsterdam UMC

Amsterdam, Netherlands
Auckland City Hospital

Auckland, Auckland, 1023, New Zealand
Baylor Scott and White

Plano, Texas, 75093, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States
Buffalo VA Western New York

Buffalo, New York, 14215, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States
Corewell Health

Grand Rapids, Michigan, 49503, United States
Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Delray Medical Center

Delray Beach, Florida, 33484, United States
ETZ Elisabeth

Tilburg, Tilburg, 5022 GC, Netherlands
Emory University Hospital

Atlanta, Georgia, 30322, United States
Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands
Honor Health

Scottsdale, Arizona, 85258, United States
Hopital Cardiologie

Lille, Hauts-de-France, 59037, France
Houston Methodist

Houston, Texas, 77030, United States
Indiana University

Indianapolis, Indiana, 46202, United States
Inova Schar Heart and Vascular

Falls Church, Virginia, 22042, United States
Johns Hopkins

Baltimore, Maryland, 21205, United States
Maine Medical

Portland, Maine, 04102, United States
Marie Lannelongue Hospital

Paris, Le Plessis-Robinson, 92350,, France
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mayo Clinic

Rochester, Minnesota, 55902, United States
Mt. Sinai Medical Center

Miami Beach, Florida, 33140, United States
NYU Langone

New York, New York, 10016, United States
Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States
Orlando Health

Orlando, Florida, 32806, United States
Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands
San Diego VA Medical Center

San Diego, California, 92161, United States
Sanford Health

Sioux Falls, South Dakota, 57105, United States
Sentara Norfolk General

Norfolk, Virginia, 23507, United States
St Georges University Hospitals NHS Foundation Trust

London, SW17 0GT, United Kingdom
St. David's Healthcare

Austin, Texas, 78705, United States
St. Marys Hospital

London, W21 1NY, United Kingdom
Stony Brook Medicine

Stony Brook, New York, 11794, United States
The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States
TriHealth Heart Institute

Cincinnati, Ohio, 45242, United States
USC Keck

Los Angeles, California, 90033, United States
University at Buffalo

Buffalo, New York, 14203, United States
University of Alabama Birmingham

Birmingham, Alabama, 35233, United States
University of Chicago

Chicago, Illinois, 60637, United States
University of Rochester

Rochester, New York, 14642, United States
University of South Florida

Tampa, Florida, 33606, United States
University of Virginia

Charlottesville, Virginia, 22903, United States
University of Wisconsin

Madison, Wisconsin, 53715, United States
VA Ann Arbor Healthcare

Ann Arbor, Michigan, 48105, United States
Vanderbilt University

Nashville, Tennessee, 37232, United States
Waikato Hospital

Hamilton, 3204, New Zealand

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