ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES (SOCRATES)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Device: ESAR treatment: Endograft + Heli-FX Endoanchor; Device: FEVAR treatment : Fenestrated endograft

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karlotta Knuth; Phone Number: +4915785318893; Email: info@fcre.eu

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Recruiting
    • Hospital Ottakring, Institute for Vascular Surgery
    • Contact: Afshin Assadian
• Belgium
  • Genk, Belgium, 3600
    • Recruiting
    • CRC thoracic Vascular Surgery, ZOL Genk
    • Contact: Wouter Lansink, Dr MD
  • Ghent, Belgium, 9000
    • Recruiting
    • Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde
    • Contact: Isabelle vanHerzeele
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa ziekenhuis
    • Contact: Du Pont
• France
  • Boulogne, France
    • Recruiting
    • Amrois Paré Hospital (APHP)
    • Contact: Raphael Coscas
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert
    • Contact: Fabien Thaveau
  • Lyon, France
    • Recruiting
    • Hospices Civils de lyon - Hôpital Edouard Herriot
    • Contact: Antoine Millon
  • Rennes, France
    • Recruiting
    • Centre Hospitalier Universitaire de Rennes
    • Contact: Adrien Kaladji
• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • University Hospital RWTH Aachen
    • Contact: Alexander Gombert
  • Leipzig, Germany, 04109
    • Recruiting
    • University Hospital Leipzig
    • Contact: Dierk Scheinert
  • München, Germany, 81675
    • Recruiting
    • Klinikum der Technischen Universität München
    • Contact: Branzan
  • Münster, Germany, 48145
    • Completed
    • Martin Austermann
• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • University of Bologna, IRCCS S. Orsola Hospital,
    • Contact: Mauro Gargiulo, Prof
  • Genova, Italy, 16132
    • Recruiting
    • Az. Ospedaliera San Martino, Genova
    • Contact: Giovanni Pratesi
  • Milan, Italy, 20132
    • Recruiting
    • IRCCS Ospedale San Raffaele, Chirurgia Vascolare
    • Contact: Andrea Kahlberg, Prof
  • Perugia, Italy, 06100
    • Not yet recruiting
    • Vascular Endovascular Surgery University of Perugia;
    • Contact: Massimo Lenti, Prof MD
    • Contact: Giacomo Isernia, MD, PHD
  • Turin, Italy, 10154
    • Recruiting
    • Az.Osped.Univers.S.Giovanni, Turin
    • Contact: Fabio Verzini
  • Verona, Italy
    • Recruiting
    • Azienda Ospedaliera Universitaria Integrata di Verona
    • Contact: Veraldi
• Netherlands
  • Amsterdam, Netherlands
    • Not yet recruiting
    • VUMC Amsterdam
    • Contact: Kak Khee Yeung
  • Eindhoven, Netherlands
    • Not yet recruiting
    • Catharina Ziekenhuis
    • Contact: Philippe Cuypers
• Poland
  • Warsaw, Poland, 04-628
    • Recruiting
    • National Institute of Cardiology Warzwa
    • Contact: Piotr Szopinski
• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Ramon y Cajal
    • Contact: Andrés Reyer
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Clinico Universitario Valladolid
    • Contact: Lourdes del Rio Sola
• Switzerland
  • Bern, Switzerland, 3010
    • Not yet recruiting
    • Inselspital Bern, Universitätsklinik für Gefässchirurgie
    • Contact: Drosos Kotelis, Prof
• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • UCSD Medical Center Hillcrest
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Jason Lee
  • Florida
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • University of Florida
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Corewell Health (Spectrum)
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Rami Tadros
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Recruiting
      • Oklahoma Heart
      • Contact: Adel Barkat
  • Oregon
    • Portland, Oregon, United States, 97213
      • Recruiting
      • Providence Portland Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 14212
      • Recruiting
      • Allegheny General Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara Norfolk General Hospital
      • Contact: Hosam El-Sayed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESAR; Endovascular Aneurysm Repair + Heli-FX EndoAnchors	Device: ESAR treatment: Endograft + Heli-FX Endoanchor; ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
Active Comparator: FEVAR; Fenestrated EndoVascular Aneurysm Repair	Device: FEVAR treatment : Fenestrated endograft; Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total contrast volume (ml) at index procedure	Total contrast volume (mL) at index procedure	at index procedure
Total fluoroscopy time (minutes) at index procedure	Total fluoroscopy time (minutes) at index procedure	at index procedure
Duration (minutes) of index procedure	3. Duration (minutes) of index procedure (time between initial skin access to final closure of the last artery access site)	at index procedure
Clinical success	7. Clinical success defined as technical success + freedom from intra-operative death and freedom from type IA/III endoleak in the first post-op image within 30 days.	through 30 days post-procedure
Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up	Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up	Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up	Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up	Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up	Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up	through 12,24 and 36-months post-op
Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up	Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up	through 12,24 and 36-months post-op
Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up	Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up	Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up	through 1,12,24 and 36-months post-op
Overall SCI rate, include transient events at 1 and 12 months follow-up	Overall SCI rate, include transient events at 1 and 12 months follow-up	through 1 and 12 months post-op
Freedom from aortic neck-related secondary interventions	reinterventions for Type IAa endoleak, migration of the proximal stent graft, and progression of disease in the infrarenal aortic neck; progression of disease is defined as enlargement of the infrarenal aortic neck compared to the first postprocedural CT scan, as measured by either diameter, surface and/or volume.	at 1-, 12-, 24- and 36-months follow-up
Adequate penetration of EndoAnchor implants as assessed by the Core Lab	Adequate penetration of EndoAnchor implants as assessed by the Core Lab	at index procedure

Collaborators and Investigators

• Sponsor: FCRE (Foundation for Cardiovascular Research and Education)
• Collaborators: Medtronic
• Investigators: Principal Investigator: Giovanni Torsello, Prof. Dr., Vascupedia; Principal Investigator: Brant Ullery, MD, MBA, Medical Director, Vascular Surgery Providence Heart and Vascular Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: FCRE-191125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes