RecruitingNot ApplicableNCT04503395

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck

Sponsor

FCRE (Foundation for Cardiovascular Research and Education)

Enrollment

204 participants

Start Date

May 21, 2021

Study Type

INTERVENTIONAL

Conditions

Aortic Aneurysm, Abdominal

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ESAR treatment: Endograft + Heli-FX Endoanchor and a medical device called FEVAR treatment : Fenestrated endograft for people with aortic aneurysm, abdominal. The study is currently recruiting participants at 33 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEESAR treatment: Endograft + Heli-FX Endoanchor

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

DEVICEFEVAR treatment : Fenestrated endograft

Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft

Locations(33)

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

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

Jessa Ziekenhuis

Hasselt, 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

Klinikum der Technischen Universität München

München, 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

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Italy

VUMC Amsterdam

Amsterdam, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

National Institute of Cardiology Warzwa

Warsaw, Poland

Hospital Ramon Y Cajal

Madrid, Spain

HOSPITAL CLINICO UNIVERSITARIO Valladolid

Valladolid, Spain

Inselspital Bern, Universitätsklinik für Gefässchirurgie

Bern, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04503395

Related Trials

iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study

NCT070051412 locations

Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck

NCT0548411536 locations

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

NCT0602966049 locations

AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation

NCT074383273 locations

Zenith® Fenestrated+ Clinical Study

NCT0487542933 locations