Actively Recruiting
ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
Led by FCRE (Foundation for Cardiovascular Research and Education) · Updated on 2025-04-30
204
Participants Needed
32
Research Sites
366 weeks
Total Duration
On this page
Sponsors
F
FCRE (Foundation for Cardiovascular Research and Education)
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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�b0
You will not qualify if you...
-
Subject is participating in a concurrent study which may confound study results
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Subject has a life expectancy <2 year
-
Subject is female of childbearing potential in whom pregnancy cannot be excluded
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Subject with eGFR <30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis
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Subject with a MI or CVA within 3 months prior to index procedure
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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
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Subject has a known hypersensitivity or allergies to study device implant material
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Subject has an aneurysm that is:
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Suprarenal, pararenal, or thoracoabdominal
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Mycotic
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Inflammatory
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Pseudoaneurysm
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Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential >50%
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Pre-op stenosis of the renal arteries > 50%
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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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
UCSD Medical Center Hillcrest
La Jolla, California, United States, 92037
Actively Recruiting
2
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
3
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
4
Corewell Health (Spectrum)
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
5
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
6
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
7
Oklahoma Heart
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
8
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
9
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 14212
Actively Recruiting
10
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
11
Hospital Ottakring, Institute for Vascular Surgery
Vienna, Austria, 1160
Actively Recruiting
12
CRC thoracic Vascular Surgery, ZOL Genk
Genk, Belgium, 3600
Actively Recruiting
13
Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde
Ghent, Belgium, 9000
Actively Recruiting
14
Amrois Paré Hospital (APHP)
Boulogne, France
Actively Recruiting
15
Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert
Clermont-Ferrand, France, 63003
Actively Recruiting
16
Hospices Civils de lyon - Hôpital Edouard Herriot
Lyon, France
Actively Recruiting
17
Centre Hospitalier Universitaire de Rennes
Rennes, France
Actively Recruiting
18
University Hospital RWTH Aachen
Aachen, Germany, 52074
Actively Recruiting
19
University Hospital Leipzig
Leipzig, Germany, 04109
Actively Recruiting
20
Martin Austermann
Münster, Germany, 48145
Active, Not Recruiting
21
University of Bologna, IRCCS S. Orsola Hospital,
Bologna, Italy, 40138
Actively Recruiting
22
Az. Ospedaliera San Martino, Genova
Genova, Italy, 16132
Actively Recruiting
23
IRCCS Ospedale San Raffaele, Chirurgia Vascolare
Milan, Italy, 20132
Actively Recruiting
24
Vascular Endovascular Surgery University of Perugia;
Perugia, Italy, 06100
Not Yet Recruiting
25
Az.Osped.Univers.S.Giovanni, Turin
Turin, Italy, 10154
Actively Recruiting
26
VUMC Amsterdam
Amsterdam, Netherlands
Not Yet Recruiting
27
Catharina Ziekenhuis
Eindhoven, Netherlands
Not Yet Recruiting
28
National Institute of Cardiology Warzwa
Warsaw, Poland, 04-628
Actively Recruiting
29
Hospital Ramon Y Cajal
Madrid, Spain
Actively Recruiting
30
Hospital Universitario Donostia
San Sebastián, Spain
Actively Recruiting
31
HOSPITAL CLINICO UNIVERSITARIO Valladolid
Valladolid, Spain, 47003
Actively Recruiting
32
Inselspital Bern, Universitätsklinik für Gefässchirurgie
Bern, Switzerland, 3010
Not Yet Recruiting
Research Team
S
Sarah Litterscheid, PhD
CONTACT
S
Sarah Litterscheid
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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