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New implant aims to shrink deadly belly aneurysms and prevent rupture

NCT ID NCT06029660

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥18 years of age 2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women; 3. Thrombus burden (percentage of the AAA sac occupied by thrombus) \<50%, based on pre-procedure CTA 4. Maximum Lumen diameter within the AAA sac of ≥40mm. 5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200. Exclusion Criteria: General 1. An inability to provide informed consent. 2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial. 3. Unable or unwilling to comply with study follow-up requirements. 4. Prisoner or member of other vulnerable population Anatomical 1. Concomitant iliac artery ectasia or aneurysm 2. Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac. 3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm. 4. Connective tissue disorder (e.g., Marfan's syndrome) 5. Aneurysmal disease of the descending thoracic aorta 6. Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties EVAR/Procedural 1. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA 2. Use of an aortic stent graft other than those specified1 for a particular site 3. Planned use of the chosen stent graft outside its instructions for use (IFU) 4. Use of fenestrated stent grafts or chimney techniques 5. Use of the Heli-FX EndoAnchor system 6. Use of embolic devices other than the investigational product to embolize the AAA sac 7. Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries 8. Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries Medical History/Conditions 1. Coagulopathy or uncontrolled bleeding disorder 2. Serum creatinine level \>2.5 mg/dL 3. Cerebrovascular accident within 3 months prior to the procedure 4. Myocardial infarction and/or major heart surgery within 3 months prior to the procedure 5. Atrial fibrillation that is not well rate controlled 6. Life expectancy of \<2 years post-procedure 7. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane. 8. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC \>11,000/mm3) 9. A condition that inhibits radiographic visualization during the implantation procedure 10. History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason. 11. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial 12. Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial

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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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