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

July 8, 2026 updated by: Shape Memory Medical, Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • Hopital Cardiologie
    • Le Plessis-Robinson
      • Paris, Le Plessis-Robinson, France, 92350,
        • Marie Lannelongue Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medical Center
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6800 TA
        • Rijnstate Hospital
    • Tilburg
      • Tilburg, Tilburg, Netherlands, 5022 GC
        • ETZ Elisabeth
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Waikato Hospital
    • Auckland
      • Auckland, Auckland, New Zealand, 1023
        • Auckland City Hospital
  • United Kingdom
      • London, United Kingdom, SW17 0GT
        • St Georges University Hospitals NHS Foundation Trust
      • London, United Kingdom, W21 1NY
        • St. Marys Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama Birmingham
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health
    • California
      • Los Angeles, California, United States, 90033
        • USC Keck
      • San Diego, California, United States, 92161
        • San Diego VA Medical Center
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Delray Medical Center
      • Miami Beach, Florida, United States, 33140
        • Mt. Sinai Medical Center
      • Orlando, Florida, United States, 32806
        • Orlando Health
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • Buffalo, New York, United States, 14203
        • University at Buffalo
      • Buffalo, New York, United States, 14215
        • Buffalo VA Western New York
      • New York, New York, United States, 10016
        • NYU Langone
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center/New York Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Stony Brook, New York, United States, 11794
        • Stony Brook Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • TriHealth Heart Institute
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Hospital of the University of Pennsylvania
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Health
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Austin, Texas, United States, 78705
        • St. David's Healthcare
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • Plano, Texas, United States, 75093
        • Baylor Scott and White
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center at San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Schar Heart and Vascular
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • University Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
Device: IMPEDE-FX RapidFill Implants
Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants
Procedure: EndoVascular Aneurysm Repair
Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
Other Names:
  • EVAR
Active Comparator: Control
Control Arm: Subjects in the control arm will only have an EVAR device implanted.
Procedure: EndoVascular Aneurysm Repair
Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
Other Names:
  • EVAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
Time Frame: 1 year
The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.
1 year
Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days
Time Frame: 30 days

Freedom from the following through 30 days post-index procedure:

  • Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1000 mL.
  • AAA-rupture or AAA-perforation
  • Conversion to Open Repair
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shape Memory Medical, Inc.

Collaborators

NAMSA

Investigators

  • Principal Investigator: Marc Schermerhorn, M.D., Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD 1029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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