ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Recruiting now · Not applicable

Conditions studied: Aortic Aneurysm, Abdominal

In brief

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).

Key facts

Study ID

NCT04503395

Run by

FCRE (Foundation for Cardiovascular Research and Education)

People needed

204

Starts

2021-05-21

Expected to finish

2032-06-01

Last updated by the study team

2026-05-22

Who can join

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

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
• Aortic neck diameter from 19 to 31mm
• Infrarenal neck angulation ≤45°

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
• 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.

Where it is running

• UCSD Medical Center Hillcrest — La Jolla, California, United States (enrolling)
• Stanford University — Stanford, California, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Corewell Health (Spectrum) — Grand Rapids, Michigan, United States (enrolling)
• Mount Sinai Hospital — New York, New York, United States (enrolling)
• Oklahoma Heart — Tulsa, Oklahoma, United States (enrolling)
• Providence Portland Medical Center — Portland, Oregon, United States (enrolling)
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States (enrolling)
• Hospital Ottakring, Institute for Vascular Surgery — Vienna, Austria (enrolling)
• CRC thoracic Vascular Surgery, ZOL Genk — Genk, Belgium (enrolling)
• Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde — Ghent, Belgium (enrolling)
• Jessa Ziekenhuis — Hasselt, Belgium (enrolling)
• Amrois Paré Hospital (APHP) — Boulogne, France (enrolling)
• Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert — Clermont-Ferrand, France (enrolling)
• Hospices Civils de lyon - Hôpital Edouard Herriot — Lyon, France (enrolling)
• Centre Hospitalier Universitaire de Rennes — Rennes, France (enrolling)
• University Hospital RWTH Aachen — Aachen, Germany (enrolling)
• University Hospital Leipzig — Leipzig, Germany (enrolling)
• Klinikum der Technischen Universität München — München, Germany (enrolling)
• Az.Osped.Univers.S.Giovanni, Turin — Turin, Italy (enrolling)
• Azienda Ospedaliera Universitaria Integrata di Verona — Verona, Italy (enrolling)
• National Institute of Cardiology Warzwa — Warsaw, Poland (enrolling)
• Hospital Ramon Y Cajal — Madrid, Spain (enrolling)
• HOSPITAL CLINICO UNIVERSITARIO Valladolid — Valladolid, Spain (enrolling)

Full record on ClinicalTrials.gov

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