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

May 2, 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

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 Contact

Study Contact Backup

Study Locations

  • France
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • Recruiting
        • Hopital Cardiologie
        • Contact:
        • Principal Investigator:
          • Jonathan Sobocinski, M.D.
    • Le Plessis-Robinson
      • Paris, Le Plessis-Robinson, France, 92350,
        • Recruiting
        • Marie Lannelongue Hospital
        • Contact:
        • Principal Investigator:
          • Dominique Fabre, M.D.
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC
        • Contact:
        • Principal Investigator:
          • Arjan Hoksbergen, M.D.
        • Sub-Investigator:
          • Kak Khee Yeung, M.D.
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medical Center
        • Contact:
        • Principal Investigator:
          • Hence Verhagen, M.D.
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6800 TA
        • Recruiting
        • Rijnstate Hospital
        • Contact:
        • Principal Investigator:
          • Michel Reijnen, M.D.
        • Sub-Investigator:
          • Erik Jebbink, M.D.
        • Sub-Investigator:
          • Jan Lardenoye, M.D.
        • Sub-Investigator:
          • Luuk Smeets, M.D.
        • Sub-Investigator:
          • Paul van Schaik, M.D.
        • Sub-Investigator:
          • Stephanus van Sterkenburg, M.D.
        • Sub-Investigator:
          • Yannick 't Mannetje, M.D.
    • Tilburg
      • Tilburg, Tilburg, Netherlands, 5022 GC
        • Recruiting
        • ETZ Elisabeth
        • Contact:
        • Principal Investigator:
          • Jan Heyligers, M.D.
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Recruiting
        • Waikato Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manar Khashram, M.D.
        • Sub-Investigator:
          • Philip Allan, M.D.
        • Sub-Investigator:
          • Zubayr Zaman, M.D.
    • Auckland
      • Auckland, Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital
        • Principal Investigator:
          • Andrew Holden, MB ChB
        • Contact:
        • Sub-Investigator:
          • Andrew Hill, M.D.
        • Sub-Investigator:
          • Stephen Merrilees, M.D.
        • Sub-Investigator:
          • Anastasia Dean, M.D.
  • United Kingdom
      • London, United Kingdom, SW17 0GT
        • Recruiting
        • St Georges University Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Ian Loftus, M.D.
        • Sub-Investigator:
          • James Budge, M.D.
        • Sub-Investigator:
          • Peter Holt, M.D.
      • London, United Kingdom, W21 1NY
        • Recruiting
        • St. Marys Hospital
        • Contact:
        • Principal Investigator:
          • Mohammad Hamady, M.D.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama Birmingham
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adam Beck, M.D.
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health
        • Contact:
        • Principal Investigator:
          • Venkatesh Ramaiah, M.D.
        • Contact:
        • Sub-Investigator:
          • Stephanie Wilson, N.P.
        • Sub-Investigator:
          • Hasan Aldailami, M.D.
    • California
      • Los Angeles, California, United States, 90033
      • San Diego, California, United States, 92161
        • Recruiting
        • San Diego VA Medical Center
        • Contact:
        • Principal Investigator:
          • Ann Gaffey, M.D.
    • Florida
      • Delray Beach, Florida, United States, 33484
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mt. Sinai Medical Center
        • Principal Investigator:
          • Michael Ayad, M.D.
        • Contact:
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health
        • Contact:
        • Principal Investigator:
          • Aleem Mirza, M.D.
        • Sub-Investigator:
          • Gino Casteneda, M.D.
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Halim Yammine, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Principal Investigator:
          • Yazan Duwayri, M.D.
        • Sub-Investigator:
          • James Chang, M.D.
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
        • Principal Investigator:
          • Trissa Babrowski, M.D.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
        • Principal Investigator:
          • Raghu Motaganahalli, M.D.
        • Sub-Investigator:
          • Gregory Westin, M.D.
        • Sub-Investigator:
          • Andres Fajardo, M.D.
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical
        • Contact:
        • Principal Investigator:
          • Kristina Giles, M.D.
        • Sub-Investigator:
          • Sarah Deery, M.D.
        • Sub-Investigator:
          • Kimberly Malka, M.D.
        • Sub-Investigator:
          • Brian Nolan, M.D.
        • Sub-Investigator:
          • Scott Robinson, M.D.
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins
        • Contact:
        • Principal Investigator:
          • Caitlin Hicks, M.D.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Matthew Eagleton, M.D.
        • Sub-Investigator:
          • Anahita Dua, M.D.
        • Sub-Investigator:
          • Sunita Srivastava, M.D.
        • Sub-Investigator:
          • Abhisekh Mohapatra, M.D.
        • Sub-Investigator:
          • Glenn LaMuraglia, M.D.
        • Sub-Investigator:
          • Nikolaos Zacharias, M.D.
        • Sub-Investigator:
          • Jahan Mohebali, M.D.
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Marc Schermerhorn, M.D.
        • Contact:
        • Sub-Investigator:
          • Allen Hamdan, M.D.
        • Sub-Investigator:
          • Lars Stangenberg, M.D.
        • Sub-Investigator:
          • Mark Wyers, M.D.
        • Sub-Investigator:
          • Patric Liang, M.D.
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham & Women's Hospital
        • Contact:
        • Principal Investigator:
          • Nicholas Swerdlow, M.D.
        • Sub-Investigator:
          • Mohamad Hussain, M.D.
        • Sub-Investigator:
          • Omar Selim, M.D.
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • VA Ann Arbor Healthcare
        • Contact:
        • Principal Investigator:
          • Nicholas Osborne, M.D.
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health
        • Principal Investigator:
          • Eanas S. Yassa, M.D.
        • Contact:
        • Sub-Investigator:
          • Justin Simmons, M.D.
        • Sub-Investigator:
          • Andrew Kimball, M.D.
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Randall DeMartino, M.D.
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • Bjoern Suckow, M.D.
        • Sub-Investigator:
          • Jocelyn Beach
        • Sub-Investigator:
          • Matthew Alef, M.D.
        • Sub-Investigator:
          • Jesse Columbo, M.D.
        • Sub-Investigator:
          • Rebecca Scully, M.D.
        • Sub-Investigator:
          • Jennifer Stableford, M.D.
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo
        • Contact:
        • Principal Investigator:
          • Linda Harris, M.D.
      • Buffalo, New York, United States, 14215
        • Recruiting
        • Buffalo VA Western New York
        • Contact:
        • Principal Investigator:
          • Hasan Dosluoglu, M.D.
        • Sub-Investigator:
          • Mariel Rivero, M.D.
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center/New York Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Virendra Patel, M.D., MPH
        • Sub-Investigator:
          • Danielle Bajakian, M.D.
        • Sub-Investigator:
          • Edvard Skripochnik, M.D.
        • Sub-Investigator:
          • Nicholas Morrissey, M.D.
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
        • Principal Investigator:
          • Grayson Pitcher, M.D.
        • Sub-Investigator:
          • Michael Stoner, M.D.
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook Medicine
        • Contact:
        • Principal Investigator:
          • Apostolos Tassiopoulos, M.D.
        • Sub-Investigator:
          • Angela Kokkosis, M.D.
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Trihealth Heart Institute
        • Contact:
        • Principal Investigator:
          • Patrick Muck, M.D.
        • Sub-Investigator:
          • Matthew Recht, M.D.
        • Sub-Investigator:
          • Mark Broering, M.D.
        • Sub-Investigator:
          • Adam Reichard, M.D.
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Wexner Medical Center
        • Contact:
        • Principal Investigator:
          • Kristine Orion, M.D.
        • Sub-Investigator:
          • Bryan Tillman, M.D.
        • Sub-Investigator:
          • Kyongjune Lee, M.D.
        • Sub-Investigator:
          • Xiaoyi Teng, M.D.
    • Pennsylvania
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Health
        • Contact:
        • Principal Investigator:
          • Anand Dayama, M.D.
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University
        • Contact:
        • Principal Investigator:
          • Daniel Clair, M.D.
        • Sub-Investigator:
          • Clifford Garrard, M.D.
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • St. David's Healthcare
        • Contact:
        • Principal Investigator:
          • Ryan Turley, M.D.
      • Houston, Texas, United States, 77030
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott and White
        • Contact:
        • Principal Investigator:
          • John Kedora, M.D.
        • Sub-Investigator:
          • Javier Vasquez, M.D.
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Matthew Sideman, M.D.
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Behzad Farivar, M.D.
        • Sub-Investigator:
          • Margaret Tracci, M.D.
        • Sub-Investigator:
          • William Clouse, M.D.
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Schar Heart and Vascular
        • Principal Investigator:
          • Dipankar Mukherjee, M.D.
        • Contact:
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General
        • Contact:
          • Georgia Yelken
        • Principal Investigator:
          • Animesh Rathore, M.D.
        • Sub-Investigator:
          • Hosam El Sayed, M.D.
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • University of Wisconsin
        • Contact:
        • Principal Investigator:
          • Dai Yamanouchi, M.D.
        • Sub-Investigator:
          • Courtney Morgan, M.D.
        • Sub-Investigator:
          • Kyla Bennett, M.D.

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)

June 1, 2027

Study Completion (Estimated)

June 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)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

May 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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