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

NCT06029660 | Recruiting DMC FDA Device

• 1 other identifier: CRD 1029
• Study Type: interventional
• Target: 180
• Locations: 5 countries
• Sites: 49

Brief Summary

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.

Conditions

Aortic Aneurysm, Abdominal

Keywords

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint : AAA Sac Regression at 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

  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

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.

Device: IMPEDE-FX RapidFill Implants; Procedure: EndoVascular Aneurysm Repair

Control

ACTIVE COMPARATOR

Control Arm: Subjects in the control arm will only have an EVAR device implanted.

Procedure: EndoVascular Aneurysm Repair

Interventions

IMPEDE-FX RapidFill Implants DEVICE

Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants

Treatment

EndoVascular Aneurysm Repair PROCEDURE

Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.

Also known as: EVAR

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;
• Thrombus burden (percentage of the AAA sac occupied by thrombus) \<50%, based on pre-procedure CTA
• Maximum Lumen diameter within the AAA sac of ≥40mm.
• The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200.

You may not qualify if:

• General
• An inability to provide informed consent.
• Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
• Unable or unwilling to comply with study follow-up requirements.
• Prisoner or member of other vulnerable population
• Anatomical
• Concomitant iliac artery ectasia or aneurysm
• Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.
• Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.
• Connective tissue disorder (e.g., Marfan's syndrome)
• Aneurysmal disease of the descending thoracic aorta
• Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties
• EVAR/Procedural
• 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
• Use of an aortic stent graft other than those specified1 for a particular site

Sponsors & Collaborators

• Shape Memory Medical, Inc.: lead
• NAMSA: collaborator

Study Sites (49)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Honor Health

Scottsdale, Arizona, 85258, United States

RECRUITING

USC Keck

Los Angeles, California, 90033, United States

RECRUITING

San Diego VA Medical Center

San Diego, California, 92161, United States

RECRUITING

Delray Medical Center

Delray Beach, Florida, 33484, United States

RECRUITING

Mt. Sinai Medical Center

Miami Beach, Florida, 33140, United States

RECRUITING

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Maine Medical

Portland, Maine, 04102, United States

RECRUITING

Johns Hopkins

Baltimore, Maryland, 21205, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

VA Ann Arbor Healthcare

Ann Arbor, Michigan, 48105, United States

RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

University at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Buffalo VA Western New York

Buffalo, New York, 14215, United States

RECRUITING

NYU Langone

New York, New York, 10016, United States

RECRUITING

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Stony Brook Medicine

Stony Brook, New York, 11794, United States

RECRUITING

TriHealth Heart Institute

Cincinnati, Ohio, 45242, United States

RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Sanford Health

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

RECRUITING

St. David's Healthcare

Austin, Texas, 78705, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott and White

Plano, Texas, 75093, United States

RECRUITING

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Inova Schar Heart and Vascular

Falls Church, Virginia, 22042, United States

RECRUITING

Sentara Norfolk General

Norfolk, Virginia, 23507, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53715, United States

RECRUITING

Hopital Cardiologie

Lille, Hauts-de-France, 59037, France

RECRUITING

Marie Lannelongue Hospital

Paris, Le Plessis-Robinson, 92350,, France

RECRUITING

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

RECRUITING

ETZ Elisabeth

Tilburg, Tilburg, 5022 GC, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

RECRUITING

Auckland City Hospital

Auckland, Auckland, 1023, New Zealand

RECRUITING

Waikato Hospital

Hamilton, 3204, New Zealand

RECRUITING

St Georges University Hospitals NHS Foundation Trust

London, SW17 0GT, United Kingdom

RECRUITING

St. Marys Hospital

London, W21 1NY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Marc Schermerhorn, M.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Martin

CONTACT

707.849.2213; amartin@namsa.com

Peter Miller, M.S.

CONTACT

p.miller@shapemem.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Subjects will be blinded to the treatment arm prior to the index procedure; after the procedure, they will be unblinded prior to discharge to prevent unintentional unblinding due to imaging
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, multicenter, randomized, open-label trial.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: April 5, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (39); NL (4); FR (2); NZ (2); GB (2)