RecruitingNot ApplicableNCT06029660

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

Sponsor

Shape Memory Medical, Inc.

Enrollment

180 participants

Start Date

Apr 5, 2024

Study Type

INTERVENTIONAL

Conditions

Aortic Aneurysm, Abdominal

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called EndoVascular Aneurysm Repair and a medical device called IMPEDE-FX RapidFill Implants for people with aortic aneurysm, abdominal. The study is currently recruiting participants at 49 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIMPEDE-FX RapidFill Implants

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

PROCEDUREEndoVascular Aneurysm Repair

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

Locations(49)

University of Alabama Birmingham

Birmingham, Alabama, United States

Honor Health

Scottsdale, Arizona, United States

USC Keck

Los Angeles, California, United States

San Diego VA Medical Center

San Diego, California, United States

Delray Medical Center

Delray Beach, Florida, United States

Mt. Sinai Medical Center

Miami Beach, Florida, United States

Orlando Health

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Maine Medical

Portland, Maine, United States

Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

VA Ann Arbor Healthcare

Ann Arbor, Michigan, United States

Corewell Health

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

University at Buffalo

Buffalo, New York, United States

Buffalo VA Western New York

Buffalo, New York, United States

NYU Langone

New York, New York, United States

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, United States

University of Rochester

Rochester, New York, United States

Stony Brook Medicine

Stony Brook, New York, United States

TriHealth Heart Institute

Cincinnati, Ohio, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Sanford Health

Sioux Falls, South Dakota, United States

Vanderbilt University

Nashville, Tennessee, United States

St. David's Healthcare

Austin, Texas, United States

Houston Methodist

Houston, Texas, United States

Baylor Scott and White

Plano, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Inova Schar Heart and Vascular

Falls Church, Virginia, United States

Sentara Norfolk General

Norfolk, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

Hopital Cardiologie

Lille, Hauts-de-France, France

Marie Lannelongue Hospital

Paris, Le Plessis-Robinson, France

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

ETZ Elisabeth

Tilburg, Tilburg, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Auckland City Hospital

Auckland, Auckland, New Zealand

Waikato Hospital

Hamilton, New Zealand

St Georges University Hospitals NHS Foundation Trust

London, United Kingdom

St. Marys Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06029660

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