RecruitingAortic Aneurysm, Abdominal
ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
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About this study
The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).
Sponsor: FCRE (Foundation for Cardiovascular Research and Education)
You may qualify if…
- ✓ Subject is \>18 years old
- ✓ Subject is scheduled for primary treatment of the abdominal aortic aneurysm with a non-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that is sufficiently healthy for a proximal neck length that is at least 4mm and not more than15 mm and has a circumferential minimum sealing zone length of 8 mm
- ✓ Subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core Lab screening
- ✓ Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
- ✓ Subject has provided written informed consent
- ✓ CT Angiographic Inclusion Criteria
- ✓ Subject meets the other anatomical requirements according to the locally applicable Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated Anaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructions for Use
- ✓ Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm
You may not qualify if…
- ✕ Subject is participating in a concurrent study which may confound study results
- ✕ Subject has a life expectancy \<2 year
- ✕ Subject is female of childbearing potential in whom pregnancy cannot be excluded
- ✕ Subject with eGFR \<30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis
- ✕ Subject with a MI or CVA within 3 months prior to index procedure
- ✕ Subject with known Connective Tissue Disease
- ✕ Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment
- ✕ Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm
Where it's recruiting
California
La Jolla · Stanford
Florida
Gainesville
Michigan
Grand Rapids
New York
New York
Oklahoma
Tulsa
Oregon
Portland
Pennsylvania
Pittsburgh
Virginia
Norfolk
Source: ClinicalTrials.gov · NCT04503395 · last updated 2026-05-22