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

Running, not enrolling · Not applicable

Conditions studied: Aortic Aneurysm, Abdominal

In brief

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.

Key facts

Study ID

NCT06029660

Run by

Shape Memory Medical, Inc.

People needed

180

Starts

2024-04-05

Expected to finish

2031-07-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• General
• An inability to provide informed consent.
• Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
• Unable or unwilling to comply with study follow-up requirements.
• Prisoner or member of other vulnerable population
• Anatomical
• Concomitant iliac artery ectasia or aneurysm
• Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.
• Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.
• Connective tissue disorder (e.g., Marfan's syndrome)
• Aneurysmal disease of the descending thoracic aorta
• Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties
• EVAR/Procedural
• 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
• Use of an aortic stent graft other than those specified1 for a particular site
• Planned use of the chosen stent graft outside its instructions for use (IFU)
• 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 AAA sac
• Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries
• Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries
• Medical History/Conditions
• Coagulopathy or uncontrolled bleeding disorder
• Serum creatinine level >2.5 mg/dL
• Cerebrovascular accident within 3 months prior to the procedure

Where it is running

• 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

Full record on ClinicalTrials.gov

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