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ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
Sponsor: FCRE (Foundation for Cardiovascular Research and Education)
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).
Official title: Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2021-05-21
Completion Date
2028-06-01
Last Updated
2025-04-30
Healthy Volunteers
No
Conditions
Interventions
ESAR treatment: Endograft + Heli-FX Endoanchor
ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
FEVAR treatment : Fenestrated endograft
Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft
Locations (32)
UCSD Medical Center Hillcrest
La Jolla, California, United States
Stanford University
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
Corewell Health (Spectrum)
Grand Rapids, Michigan, United States
Mount Sinai Hospital
New York, New York, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
Oklahoma Heart
Tulsa, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Hospital Ottakring, Institute for Vascular Surgery
Vienna, Austria
CRC thoracic Vascular Surgery, ZOL Genk
Genk, Belgium
Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde
Ghent, Belgium
Amrois Paré Hospital (APHP)
Boulogne, France
Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert
Clermont-Ferrand, France
Hospices Civils de lyon - Hôpital Edouard Herriot
Lyon, France
Centre Hospitalier Universitaire de Rennes
Rennes, France
University Hospital RWTH Aachen
Aachen, Germany
University Hospital Leipzig
Leipzig, Germany
Martin Austermann
Münster, Germany
University of Bologna, IRCCS S. Orsola Hospital,
Bologna, Italy
Az. Ospedaliera San Martino, Genova
Genova, Italy
IRCCS Ospedale San Raffaele, Chirurgia Vascolare
Milan, Italy
Vascular Endovascular Surgery University of Perugia;
Perugia, Italy
Az.Osped.Univers.S.Giovanni, Turin
Turin, Italy
VUMC Amsterdam
Amsterdam, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
National Institute of Cardiology Warzwa
Warsaw, Poland
Hospital Ramon Y Cajal
Madrid, Spain
Hospital Universitario Donostia
San Sebastián, Spain
HOSPITAL CLINICO UNIVERSITARIO Valladolid
Valladolid, Spain
Inselspital Bern, Universitätsklinik für Gefässchirurgie
Bern, Switzerland