Actively Recruiting
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Led by Shape Memory Medical, Inc. · Updated on 2026-05-06
180
Participants Needed
49
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Shape Memory Medical, Inc.
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the IMPEDE-FX RapidFill device used alongside standard endovascular aneurysm repair (EVAR) to treat abdominal aortic aneurysms (AAA). The study aims to increase the percentage of patients experiencing shrinkage of the aneurysm sac after treatment. This trial is conducted by Shape Memory Medical, Inc. and focuses on patients who are candidates for elective EVAR due to an infrarenal fusiform aortic aneurysm. Participants will be randomly assigned to one of two groups: the treatment group, which will receive both an EVAR stent graft and IMPEDE-FX RapidFill implants to fill the aneurysm sac, and the control group, which will receive only the EVAR stent graft. The IMPEDE-FX RapidFill device is a medical implant designed to fill the flow lumen within the aneurysm sac. Treatment follows standard EVAR procedures using approved stent graft devices. During the study, participants will be monitored for aneurysm sac regression at one year as the primary effectiveness measure. Safety is evaluated by tracking major adverse events within 30 days of the procedure. Follow-up includes assessments of aneurysm size and complications related to the treatment. The overall participation will last at least one year, with regular check-ups to observe aneurysm healing and patient safety.
CONDITIONS
Brief Title
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Candidate for elective EVAR of an infrarenal fusiform aortic aneurysm 5.5 cm or larger in men, and 5.0 cm or larger in women
- Thrombus burden less than 50% of the aneurysm sac based on pre-procedure CT angiography
- Maximum lumen diameter within the aneurysm sac of 40 mm or less
- Predicted minimum number of IMPEDE-FX RapidFill implants needed is 200 or less
You will not qualify if you...
- Unable to provide informed consent
- Enrolled in another clinical study that could affect trial outcomes
- Unable or unwilling to comply with study follow-up requirements
- Prisoner or member of a vulnerable population
- Presence of iliac artery ectasia or aneurysm
- Vascular disease or anatomy preventing safe catheter access for device delivery
- Ruptured, leaking, inflammatory, or infected aneurysm
- Connective tissue disorders such as Marfan's syndrome
- Aneurysm disease of the descending thoracic aorta
- Excessive calcification at the aortic bifurcation leading to access difficulties
- Use of aortic stent grafts other than specified approved devices
- Planned use of stent graft outside its instructions for use
- Use of fenestrated stent grafts or chimney techniques
- Use of the Heli-FX EndoAnchor system
- Use of embolic devices other than the investigational product to embolize the aneurysm sac
- Use of embolic products to embolize arteries such as inferior mesenteric, lumbar, renal accessory, or internal iliac arteries
- Inability to position the distal portion of the EVAR stent graft limbs above the internal iliac arteries
- Coagulopathy or uncontrolled bleeding disorder
- Serum creatinine level above 2.5 mg/dL
- Stroke within 3 months prior to the procedure
- Heart attack or major heart surgery within 3 months prior to the procedure
- Atrial fibrillation that is not well rate controlled
- Life expectancy less than 2 years after the procedure
- Known allergy to platinum, iridium, or polyurethane
- Active infection at the time of procedure
- Condition preventing clear imaging during implantation
- Allergy to contrast medium that is not medically manageable or inability to have CT with contrast
- Uncontrolled medical or mental health conditions affecting participation
- Pregnant or breastfeeding females or refusal to use medically accepted birth control during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants receive a standard EndoVascular Aneurysm Repair (EVAR) procedure. Those in the treatment arm also receive IMPEDE-FX RapidFill implants inserted into the aneurysm sac.
1 procedure visit (in-person)
Duration - Up to 1 year
Participants are monitored for safety and effectiveness outcomes including aneurysm sac regression and adverse events following the procedure.
Multiple visits over 1 year for follow-up assessments
Trial Site Locations
Total: 49 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
USC Keck
Los Angeles, California, United States, 90033
Actively Recruiting
4
San Diego VA Medical Center
San Diego, California, United States, 92161
Actively Recruiting
5
Delray Medical Center
Delray Beach, Florida, United States, 33484
Actively Recruiting
6
Mt. Sinai Medical Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
7
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
8
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
9
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
10
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
11
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
12
Maine Medical
Portland, Maine, United States, 04102
Actively Recruiting
13
Johns Hopkins
Baltimore, Maryland, United States, 21205
Actively Recruiting
14
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
15
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
16
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
17
VA Ann Arbor Healthcare
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
18
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
19
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
20
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
21
University at Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
22
Buffalo VA Western New York
Buffalo, New York, United States, 14215
Actively Recruiting
23
NYU Langone
New York, New York, United States, 10016
Actively Recruiting
24
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
25
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
26
Stony Brook Medicine
Stony Brook, New York, United States, 11794
Actively Recruiting
27
TriHealth Heart Institute
Cincinnati, Ohio, United States, 45242
Actively Recruiting
28
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
29
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
30
Sanford Health
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
31
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
32
St. David's Healthcare
Austin, Texas, United States, 78705
Actively Recruiting
33
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
34
Baylor Scott and White
Plano, Texas, United States, 75093
Actively Recruiting
35
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
36
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
37
Inova Schar Heart and Vascular
Falls Church, Virginia, United States, 22042
Actively Recruiting
38
Sentara Norfolk General
Norfolk, Virginia, United States, 23507
Actively Recruiting
39
University of Wisconsin
Madison, Wisconsin, United States, 53715
Actively Recruiting
40
Hopital Cardiologie
Lille, Hauts-de-France, France, 59037
Actively Recruiting
41
Marie Lannelongue Hospital
Paris, Le Plessis-Robinson, France, 92350,
Actively Recruiting
42
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA
Actively Recruiting
43
ETZ Elisabeth
Tilburg, Tilburg, Netherlands, 5022 GC
Actively Recruiting
44
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
45
Erasmus Medical Center
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
46
Auckland City Hospital
Auckland, Auckland, New Zealand, 1023
Actively Recruiting
47
Waikato Hospital
Hamilton, New Zealand, 3204
Actively Recruiting
48
St Georges University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0GT
Actively Recruiting
49
St. Marys Hospital
London, United Kingdom, W21 1NY
Actively Recruiting
Research Team
A
Ann Martin
P
Peter Miller, M.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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