ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES (SOCRATES)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2026
  • participants needed
    204
  • sponsor
    Prof. Giovanni Torsello
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Updated on 25 March 2022
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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 from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).

Details
Condition Aortic Aneurysm, Abdominal
Treatment ESAR treatment: Endograft + Heli-FX Endoanchor, FEVAR treatment : Fenestrated endograft
Clinical Study IdentifierNCT04503395
SponsorProf. Giovanni Torsello
Last Modified on25 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 and effective standard EVAR
Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
Subject has provided written informed consent
Subject is an eligible candidate according to the Endurant II/IIs + Heli-FX EndoAnchor, Cook Zenith Fenestrated Graft, and Terumo Fenestrated Anaconda Instructions For Use
Aortic neck diameter from 19 to 31mm
Iliac diameters with a range from 9 to 21mm
Infrarenal neck angulation ≤45°
Distal fixation length(s) of ≥30mm

Exclusion Criteria

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
Pre-op stenosis of the renal arteries > 50%
circumferential >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
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