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

NCT06029660 | Active Not 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

Location

Honor Health

Scottsdale, Arizona, 85258, United States

Location

USC Keck

Los Angeles, California, 90033, United States

Location

San Diego VA Medical Center

San Diego, California, 92161, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Mt. Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Maine Medical

Portland, Maine, 04102, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

VA Ann Arbor Healthcare

Ann Arbor, Michigan, 48105, United States

Location

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

Buffalo VA Western New York

Buffalo, New York, 14215, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

TriHealth Heart Institute

Cincinnati, Ohio, 45242, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57105, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

St. David's Healthcare

Austin, Texas, 78705, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Baylor Scott and White

Plano, Texas, 75093, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Inova Schar Heart and Vascular

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General

Norfolk, Virginia, 23507, United States

Location

University of Wisconsin

Madison, Wisconsin, 53715, United States

Location

Hopital Cardiologie

Lille, Hauts-de-France, 59037, France

Location

Marie Lannelongue Hospital

Paris, Le Plessis-Robinson, 92350,, France

Location

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

Location

ETZ Elisabeth

Tilburg, Tilburg, 5022 GC, Netherlands

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

Location

Auckland City Hospital

Auckland, Auckland, 1023, New Zealand

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

St Georges University Hospitals NHS Foundation Trust

London, SW17 0GT, United Kingdom

Location

St. Marys Hospital

London, W21 1NY, United Kingdom

Location

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

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): July 1, 2027
• Study Completion (Estimated): July 1, 2031
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

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