AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥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.
Locations
United States
Alabama
University of Alabama Birmingham
RECRUITING
Birmingham
Arizona
Honor Health
RECRUITING
Scottsdale
California
USC Keck
RECRUITING
Los Angeles
San Diego VA Medical Center
RECRUITING
San Diego
Florida
Delray Medical Center
RECRUITING
Delray Beach
Orlando Health
RECRUITING
Orlando
Georgia
Emory University Hospital
RECRUITING
Atlanta
Illinois
University of Chicago
RECRUITING
Chicago
Indiana
Indiana University
RECRUITING
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Brigham & Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maine
Maine Medical
RECRUITING
Portland
Michigan
Corewell Health
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic
RECRUITING
Rochester
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
New York
Buffalo VA Western New York
RECRUITING
Buffalo
Columbia University Medical Center
RECRUITING
New York
NYU Langone
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Stony Brook Medicine
RECRUITING
Stony Brook
Ohio
TriHealth Heart Institute
RECRUITING
Cincinnati
Ohio State University Wexner Medical Center
RECRUITING
Columbus
Pennsylvania
The Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
South Dakota
Sanford Health
RECRUITING
Sioux Falls
Tennessee
Vanderbilt University
RECRUITING
Nashville
Texas
Houston Methodist
RECRUITING
Houston
Baylor Scott and White
RECRUITING
Plano
The University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Virginia
University of Virginia
RECRUITING
Charlottesville
Inova Schar Heart and Vascular
RECRUITING
Falls Church
Sentara Norfolk General
RECRUITING
Norfolk
Wisconsin
University of Wisconsin
RECRUITING
Madison
Other Locations
France
Marie Lannelongue Hospital
RECRUITING
Paris
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Rijnstate Hospital
RECRUITING
Arnhem
Erasmus Medical Center
RECRUITING
Rotterdam
ETZ Elisabeth
RECRUITING
Tilburg
New Zealand
Auckland City Hospital
RECRUITING
Auckland
United Kingdom
St Georges University Hospitals NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Ann Martin
amartin@namsa.com
707.849.2213
Backup
Peter Miller, M.S.
p.miller@shapemem.com
Time Frame
Start Date: 2024-04-05
Estimated Completion Date: 2031-06
Participants
Target number of participants: 180
Treatments
Experimental: Treatment
Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
Active_comparator: Control
Control Arm: Subjects in the control arm will only have an EVAR device implanted.
Related Therapeutic Areas
Sponsors
Leads: Shape Memory Medical, Inc.
Collaborators: NAMSA