Status:
RECRUITING
ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
Lead Sponsor:
FCRE (Foundation for Cardiovascular Research and Education)
Collaborating Sponsors:
Medtronic
Conditions:
Aortic Aneurysm, Abdominal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 fro...
Eligibility Criteria
Inclusion
- 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
- Aortic neck diameter from 19 to 31mm
- Infrarenal neck angulation ≤45°
Exclusion
- 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
- Subject requires emergent aneurysm treatment, for example, trauma or rupture
- Subject has a known hypersensitivity or allergies to study device implant material
- Subject has an aneurysm that is:
- Suprarenal, pararenal, or thoracoabdominal
- Mycotic
- Inflammatory
- Pseudoaneurysm
- Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential \>50%
- Pre-op stenosis of the renal arteries \> 50%
- Subject has active infection or history of COVID-19. History of COVID-19 is defined as availability of positive COVID-19 test with sequelae or hospitalization for treatment of COVID-19.
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04503395
Start Date
May 21 2021
End Date
June 1 2028
Last Update
April 30 2025
Active Locations (32)
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1
UCSD Medical Center Hillcrest
La Jolla, California, United States, 92037
2
Stanford University
Stanford, California, United States, 94305
3
University of Florida
Gainesville, Florida, United States, 32608
4
Corewell Health (Spectrum)
Grand Rapids, Michigan, United States, 49503