AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
NCT ID: NCT06029660
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2024-04-05
2031-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
IMPEDE-FX RapidFill Implants
Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants
EndoVascular Aneurysm Repair
Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
Control
Control Arm: Subjects in the control arm will only have an EVAR device implanted.
EndoVascular Aneurysm Repair
Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
Interventions
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IMPEDE-FX RapidFill Implants
Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants
EndoVascular Aneurysm Repair
Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;
3. Thrombus burden (percentage of the AAA sac occupied by thrombus) \<50%, based on pre-procedure CTA
4. Maximum Lumen diameter within the AAA sac of ≥40mm.
5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200.
Exclusion Criteria
1. An inability to provide informed consent.
2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
3. Unable or unwilling to comply with study follow-up requirements.
4. Prisoner or member of other vulnerable population
Anatomical
1. Concomitant iliac artery ectasia or aneurysm
2. Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.
3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.
4. Connective tissue disorder (e.g., Marfan's syndrome)
5. Aneurysmal disease of the descending thoracic aorta
6. Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties
EVAR/Procedural
1. 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
2. Use of an aortic stent graft other than those specified1 for a particular site
3. Planned use of the chosen stent graft outside its instructions for use (IFU)
4. Use of fenestrated stent grafts or chimney techniques
5. Use of the Heli-FX EndoAnchor system
6. Use of embolic devices other than the investigational product to embolize the AAA sac
7. Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries
8. Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries
Medical History/Conditions
1. Coagulopathy or uncontrolled bleeding disorder
2. Serum creatinine level \>2.5 mg/dL
3. Cerebrovascular accident within 3 months prior to the procedure
4. Myocardial infarction and/or major heart surgery within 3 months prior to the procedure
5. Atrial fibrillation that is not well rate controlled
6. Life expectancy of \<2 years post-procedure
7. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.
8. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC \>11,000/mm3)
9. A condition that inhibits radiographic visualization during the implantation procedure
10. History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason.
11. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial
12. Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial
18 Years
ALL
No
Sponsors
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NAMSA
OTHER
Shape Memory Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Schermerhorn, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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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
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
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
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
Countries
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Central Contacts
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Facility Contacts
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Georgia Yelken
Role: primary
Other Identifiers
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CRD 1029
Identifier Type: -
Identifier Source: org_study_id
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