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SOCRATES Trial: Comparing ESAR and FEVAR for Abdominal Aortic Aneurysms

This study, called SOCRATES, is comparing two ways to treat abdominal aortic aneurysms (a bulge in the main artery in your belly) when the 'neck' of the aneurysm is short (4 to 15mm). It's testing the ESAR treatment, which uses an Endurant II or Endurant IIs endograft with a Heli-FX Endoanchor, against the FEVAR treatment, which uses either a Cook Zenith Fenestrated Graft or a Terumo Fenestrated Anaconda Graft. You might be able to join if you are over 18 and are scheduled for primary treatment of an abdominal aortic aneurysm with a specific healthy area for the graft. The study will look at how well the treatments work (technical success) up to 12 months after the procedure, and how safe they are (freedom from major problems) for 30 days after the procedure. The current status of this study is unclear.

Study design
This is an interventional, randomized study planning to enroll 204 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track the effectiveness of the treatment for up to 12 months and safety for 30 days after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04503395

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Recruiting
NAAges 18+InterventionalTreatment
FCRE (Foundation for Cardiovascular Research and Education)
~204 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:ESAR treatment: Endograft + Heli-FX EndoanchorFEVAR treatment : Fenestrated endograft

At a glance

Recruiting sites
28 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness Endpoint - Technical Success
Measured over through 12 months post-procedure
+1 more outcome measured

Conditions

Aortic Aneurysm, Abdominal

Explore related trials

Abdominal Aortic Aneurysm

Where it's being run

33 sites across 17 states
Italy6
France4
Germany4
Belgium3
California2
Netherlands2
Spain2
Florida1

Study leadership

  • Giovanni Torsello, Prof. Dr. · PRINCIPAL_INVESTIGATOR · Vascupedia
  • Brant Ullery, MD, MBA · PRINCIPAL_INVESTIGATOR · Medical Director, Vascular Surgery Providence Heart and Vascular Institute

Who to contact

Karlotta Knuth
[email protected]
+4915785318893
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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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
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.

What this trial measures

  • Effectiveness Endpoint - Technical Successthrough 12 months post-procedure

    Composite of technical success at index procedure, and freedom from type IA or type III endoleak, freedom from aneurysm related mortality (ARM), and freedom from secondary reinterventions through 12 months post index procedure.

  • Safety Endpoint - Freedom from Major Adverse Eventsthrough 30 days post-procedure

    Freedom from MAE through 30 days post index procedure. MAE defined as: All-Cause-Mortality, Bowel Ischemia, Myocardial Infraction, Procedural Blood Loss \> 1000cc, Access related complications, permanent paraplegia and paraparesis at 30 days, disabling stroke, respiratory failure, or renal complications