ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Last updated: April 28, 2025
Sponsor: FCRE (Foundation for Cardiovascular Research and Education)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Heart Disease

Cardiovascular Disease

Treatment

ESAR treatment: Endograft + Heli-FX Endoanchor

FEVAR treatment : Fenestrated endograft

Clinical Study ID

NCT04503395
FCRE-191125
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Subject is >18 years old

  • Subject is scheduled for primary treatment of the abdominal aortic aneurysm with anon-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that issufficiently healthy for a proximal neck length that is at least 4mm and not morethan15 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 tochallenging anatomical criteria as confirmed by the Core Lab screening

  • Subject is able and willing to comply with the protocol and to adhere to thefollow-up requirements.

  • Subject has provided written informed consent

CT Angiographic Inclusion Criteria

  • Subject meets the other anatomical requirements according to the locally applicableEndurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo FenestratedAnaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructionsfor Use

  • Proximal neck length of the aorta within 4-15mm and a minimum circumferentialsealing zone of 8mm

  • Aortic neck diameter from 19 to 31mm

  • Infrarenal neck angulation ≤45°

Exclusion

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 forabdominal 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 definedas availability of positive COVID-19 test with sequelae or hospitalization fortreatment of COVID-19.

Study Design

Total Participants: 204
Treatment Group(s): 2
Primary Treatment: ESAR treatment: Endograft + Heli-FX Endoanchor
Phase:
Study Start date:
May 21, 2021
Estimated Completion Date:
June 01, 2028

Connect with a study center

  • Hospital Ottakring, Institute for Vascular Surgery

    Vienna, 1160
    Austria

    Active - Recruiting

  • CRC thoracic Vascular Surgery, ZOL Genk

    Genk, 3600
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde

    Gent, 9000
    Belgium

    Active - Recruiting

  • Amrois Paré Hospital (APHP)

    Boulogne,
    France

    Active - Recruiting

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

    Clermont Ferrand, 63003
    France

    Active - Recruiting

  • Hospices Civils de lyon - Hôpital Edouard Herriot

    Lyon,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Rennes

    Rennes,
    France

    Active - Recruiting

  • University Hospital RWTH Aachen

    Aachen, 52074
    Germany

    Active - Recruiting

  • University Hospital Leipzig

    Leipzig, 04109
    Germany

    Active - Recruiting

  • University Hospital LMU Munich

    Munich, 81337
    Germany

    Site Not Available

  • Martin Austermann

    Münster, 48145
    Germany

    Site Not Available

  • University Hospital Regensburg

    Regensburg, 93053
    Germany

    Site Not Available

  • University of Bologna, IRCCS S. Orsola Hospital,

    Bologna, 40138
    Italy

    Active - Recruiting

  • Az. Ospedaliera San Martino, Genova

    Genova, 16132
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele, Chirurgia Vascolare

    Milano, 20132
    Italy

    Active - Recruiting

  • Vascular Endovascular Surgery University of Perugia;

    Perugia, 06100
    Italy

    Site Not Available

  • Az.Osped.Univers.S.Giovanni, Turin

    Turin, 10154
    Italy

    Active - Recruiting

  • VUMC Amsterdam

    Amsterdam,
    Netherlands

    Site Not Available

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Site Not Available

  • National Institute of Cardiology Warzwa

    Warszawa, 04-628
    Poland

    Active - Recruiting

  • Hospital Ramon Y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Donostia

    San Sebastián,
    Spain

    Active - Recruiting

  • HOSPITAL CLINICO UNIVERSITARIO Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Inselspital Bern, Universitätsklinik für Gefässchirurgie

    Bern, 3010
    Switzerland

    Site Not Available

  • UCSD Medical Center Hillcrest

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • Corewell Health (Spectrum)

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Oklahoma Heart

    Tulsa, Oklahoma 74104
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 14212
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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