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

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

April 5, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2031

Conditions
Aortic Aneurysm, Abdominal
Interventions
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.

Trial Locations (40)

1023

RECRUITING

Auckland City Hospital, Auckland

10016

RECRUITING

NYU Langone, New York

10032

RECRUITING

Columbia University Medical Center, New York

11794

RECRUITING

Stony Brook Medicine, Stony Brook

14215

RECRUITING

Buffalo VA Western New York, Buffalo

14642

RECRUITING

University of Rochester, Rochester

19104

RECRUITING

The Hospital of the University of Pennsylvania, Philadelphia

22042

RECRUITING

Inova Schar Heart and Vascular, Falls Church

22903

RECRUITING

University of Virginia, Charlottesville

23507

RECRUITING

Sentara Norfolk General, Norfolk

30322

RECRUITING

Emory University Hospital, Atlanta

32806

RECRUITING

Orlando Health, Orlando

33484

RECRUITING

Delray Medical Center, Delray Beach

35233

RECRUITING

University of Alabama Birmingham, Birmingham

37232

RECRUITING

Vanderbilt University, Nashville

43210

RECRUITING

Ohio State University Wexner Medical Center, Columbus

45242

RECRUITING

TriHealth Heart Institute, Cincinnati

46202

RECRUITING

Indiana University, Indianapolis

49503

RECRUITING

Corewell Health, Grand Rapids

53715

RECRUITING

University of Wisconsin, Madison

55902

RECRUITING

Mayo Clinic, Rochester

57105

RECRUITING

Sanford Health, Sioux Falls

60637

RECRUITING

University of Chicago, Chicago

75093

RECRUITING

Baylor Scott and White, Plano

77030

RECRUITING

Houston Methodist, Houston

78229

RECRUITING

The University of Texas Health Science Center at San Antonio, San Antonio

85258

RECRUITING

Honor Health, Scottsdale

90033

RECRUITING

USC Keck, Los Angeles

92161

RECRUITING

San Diego VA Medical Center, San Diego

04102

RECRUITING

Maine Medical, Portland

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Brigham & Women's Hospital, Boston

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

03756

RECRUITING

Dartmouth Hitchcock Medical Center, Lebanon

92350,

RECRUITING

Marie Lannelongue Hospital, Paris

6800 TA

RECRUITING

Rijnstate Hospital, Arnhem

5022 GC

RECRUITING

ETZ Elisabeth, Tilburg

Unknown

RECRUITING

Amsterdam UMC, Amsterdam

3015 GD

RECRUITING

Erasmus Medical Center, Rotterdam

SW17 0GT

RECRUITING

St Georges University Hospitals NHS Foundation Trust, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NAMSA

OTHER

lead

Shape Memory Medical, Inc.

INDUSTRY

NCT06029660 - AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion | Biotech Hunter | Biotech Hunter