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NCT04503395NARecruiting

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

FCRE (Foundation for Cardiovascular Research and Education)

Start Date

5/21/2021

Completion Date

6/1/2032

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 CT Angiographic Inclusion Criteria * 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° Exclusion Criteria: * 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.

Interventions

DEVICE

ESAR treatment: Endograft + Heli-FX Endoanchor

DEVICE

FEVAR treatment : Fenestrated endograft

Interested in This Trial?

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Conditions

Aortic Aneurysm, Abdominal

Locations

UCSD Medical Center Hillcrest

La Jolla, California 92037

United States

Stanford University

Stanford, California 94305

United States

University of Florida

Gainesville, Florida 32608

United States

Corewell Health (Spectrum)

Grand Rapids, Michigan 49503

United States

Mount Sinai Hospital

New York, New York 10029

United States

Oklahoma Heart

Tulsa, Oklahoma 74104

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 14212

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States

Hospital Ottakring, Institute for Vascular Surgery

Vienna, 1160

Austria

CRC thoracic Vascular Surgery, ZOL Genk

Genk, 3600

Belgium

Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde

Ghent, 9000

Belgium

Jessa Ziekenhuis

Hasselt, 3500

Belgium

Amrois Paré Hospital (APHP)

Boulogne,

France

Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert

Clermont-Ferrand, 63003

France

Hospices Civils de lyon - Hôpital Edouard Herriot

Lyon,

France

Centre Hospitalier Universitaire de Rennes

Rennes,

France

University Hospital RWTH Aachen

Aachen, 52074

Germany

University Hospital Leipzig

Leipzig, 04109

Germany

Klinikum der Technischen Universität München

München, 81675

Germany

Martin Austermann

Münster, 48145

Germany

University of Bologna, IRCCS S. Orsola Hospital,

Bologna, 40138

Italy

Az. Ospedaliera San Martino, Genova

Genova, 16132

Italy

IRCCS Ospedale San Raffaele, Chirurgia Vascolare

Milan, 20132

Italy

Vascular Endovascular Surgery University of Perugia;

Perugia, 06100

Italy

Az.Osped.Univers.S.Giovanni, Turin

Turin, 10154

Italy

Azienda Ospedaliera Universitaria Integrata di Verona

Verona,

Italy

VUMC Amsterdam

Amsterdam,

Netherlands

Catharina Ziekenhuis

Eindhoven,

Netherlands

National Institute of Cardiology Warzwa

Warsaw, 04-628

Poland

Hospital Ramon Y Cajal

Madrid,

Spain

HOSPITAL CLINICO UNIVERSITARIO Valladolid

Valladolid, 47003

Spain

Inselspital Bern, Universitätsklinik für Gefässchirurgie

Bern, 3010

Switzerland