Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04503395

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES | DecenTrialz