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RECRUITING
NCT04503395
NA

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Sponsor: FCRE (Foundation for Cardiovascular Research and Education)

View on ClinicalTrials.gov

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

Interventions

DEVICE

ESAR treatment: Endograft + Heli-FX Endoanchor

ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor

DEVICE

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