ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

NCT04503395 | Recruiting DMC FDA Device

• 1 other identifier: FCRE-191125
• Study Type: interventional
• Target: 204
• Locations: 10 countries
• Sites: 32

Brief 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).

Conditions

Aortic Aneurysm, Abdominal

Outcome Measures

Primary Outcomes (2)

• Effectiveness Endpoint - Technical Success

  Composite of technical success at index procedure, and freedom from type IA or type III endoleak, freedom from aneurysm related mortality (ARM), and freedom from secondary reinterventions through 12 months post index procedure.

  through 12 months post-procedure

• Safety Endpoint - Freedom from Major Adverse Events

  Freedom from MAE through 30 days post index procedure. MAE defined as: All-Cause-Mortality, Bowel Ischemia, Myocardial Infraction, Procedural Blood Loss \> 1000cc, Access related complications, permanent paraplegia and paraparesis at 30 days, disabling stroke, respiratory failure, or renal complications

  through 30 days post-procedure

Secondary Outcomes (15)

• Total contrast volume (ml) at index procedure

  at index procedure

• Total fluoroscopy time (minutes) at index procedure

  at index procedure

• Duration (minutes) of index procedure

  at index procedure

• Adequate penetration of EndoAnchor implants as assessed by the Core Lab

  at index procedure

• Clinical success

  through 30 days post-procedure

Study Arms (2)

ESAR

EXPERIMENTAL

Endovascular Aneurysm Repair + Heli-FX EndoAnchors

Device: ESAR treatment: Endograft + Heli-FX Endoanchor

FEVAR

ACTIVE COMPARATOR

Fenestrated EndoVascular Aneurysm Repair

Device: FEVAR treatment : Fenestrated endograft

Interventions

ESAR treatment: Endograft + Heli-FX Endoanchor DEVICE

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

ESAR

FEVAR treatment : Fenestrated endograft DEVICE

Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft

FEVAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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°

You may not qualify if:

• 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

Sponsors & Collaborators

• FCRE (Foundation for Cardiovascular Research and Education): lead
• Medtronic: collaborator

Study Sites (32)

UCSD Medical Center Hillcrest

La Jolla, California, 92037, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

Corewell Health (Spectrum)

Grand Rapids, Michigan, 49503, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

Oklahoma Heart

Tulsa, Oklahoma, 74104, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 14212, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Hospital Ottakring, Institute for Vascular Surgery

Vienna, 1160, Austria

RECRUITING

CRC thoracic Vascular Surgery, ZOL Genk

Genk, 3600, Belgium

RECRUITING

Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde

Ghent, 9000, Belgium

RECRUITING

Amrois Paré Hospital (APHP)

Boulogne, France

RECRUITING

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

Clermont-Ferrand, 63003, France

RECRUITING

Hospices Civils de lyon - Hôpital Edouard Herriot

Lyon, France

RECRUITING

Centre Hospitalier Universitaire de Rennes

Rennes, France

RECRUITING

University Hospital RWTH Aachen

Aachen, 52074, Germany

RECRUITING

University Hospital Leipzig

Leipzig, 04109, Germany

RECRUITING

Martin Austermann

Münster, 48145, Germany

ACTIVE NOT RECRUITING

University of Bologna, IRCCS S. Orsola Hospital,

Bologna, 40138, Italy

RECRUITING

Az. Ospedaliera San Martino, Genova

Genova, 16132, Italy

RECRUITING

IRCCS Ospedale San Raffaele, Chirurgia Vascolare

Milan, 20132, Italy

RECRUITING

Vascular Endovascular Surgery University of Perugia;

Perugia, 06100, Italy

NOT YET RECRUITING

Az.Osped.Univers.S.Giovanni, Turin

Turin, 10154, Italy

RECRUITING

VUMC Amsterdam

Amsterdam, Netherlands

NOT YET RECRUITING

Catharina Ziekenhuis

Eindhoven, Netherlands

NOT YET RECRUITING

National Institute of Cardiology Warzwa

Warsaw, 04-628, Poland

RECRUITING

Hospital Ramon Y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario Donostia

San Sebastián, Spain

RECRUITING

HOSPITAL CLINICO UNIVERSITARIO Valladolid

Valladolid, 47003, Spain

RECRUITING

Inselspital Bern, Universitätsklinik für Gefässchirurgie

Bern, 3010, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Giovanni Torsello, Prof. Dr.

  Vascupedia

  PRINCIPAL INVESTIGATOR

• Brant Ullery, MD, MBA

  Medical Director, Vascular Surgery Providence Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Litterscheid, PhD

CONTACT

+49 15785319015; info@fcre.eu

Sarah Litterscheid

CONTACT

+49 15785319015; sarah.litterscheid@fcre.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: comparision of two different procedure to repair abdominal aortic aneurysms with short necks

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 7, 2020
• Study Start: May 21, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); AU (1); FR (4); BE (2); NL (2); ES (3); CH (1); US (10); IT (5); PL (1)