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Aortic Aneurysm, AbdominalSOCRATESNCT04503395

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

A study testing ESAR treatment: Endograft + Heli-FX Endoanchor and FEVAR treatment : Fenestrated endograft in people with Aortic Aneurysm, Abdominal, run by FCRE (Foundation for Cardiovascular Research and Education) at 33 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Aneurysm, Abdominal
What is being tested?
ESAR treatment: Endograft + Heli-FX Endoanchor and FEVAR treatment : Fenestrated endograft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
33 sitesin 10 countries
Study dates
21 May 2021to 1 Jun 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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°

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

33 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Karlotta Knuth contact

+4915785318893

info@fcre.eu

33 sites in 10 countries

United States9 sites, 9 recruiting

  • University of Florida

    Gainesville, Florida, 32608

    Recruiting

  • Corewell Health (Spectrum)

    Grand Rapids, Michigan, 49503

    Recruiting

  • UCSD Medical Center Hillcrest

    La Jolla, California, 92037

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Rami Tadros

    Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

    Hosam El-Sayed

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 14212

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Recruiting

  • Stanford University

    Stanford, California, 94305

    Jason Lee

    Recruiting

  • Oklahoma Heart

    Tulsa, Oklahoma, 74104

    Adel Barkat

    Recruiting

Other trials in United States

Italy6 sites, 6 recruiting

  • University of Bologna, IRCCS S. Orsola Hospital,

    Bologna, 40138

    Mauro Gargiulo, Prof

    Recruiting

  • Az. Ospedaliera San Martino, Genova

    Genova, 16132

    Giovanni Pratesi

    Recruiting

  • IRCCS Ospedale San Raffaele, Chirurgia Vascolare

    Milan, 20132

    Andrea Kahlberg, Prof

    Recruiting

  • Vascular Endovascular Surgery University of Perugia;

    Perugia, 06100

    Massimo Lenti, Prof MD

    Giacomo Isernia, MD, PHD

    Not yet recruiting

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

    Turin, 10154

    Fabio Verzini

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona

    Veraldi

    Recruiting

Other trials in Italy

France4 sites, 4 recruiting

  • Amrois Paré Hospital (APHP)

    Boulogne

    Raphael Coscas

    Recruiting

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

    Clermont-Ferrand, 63003

    Fabien Thaveau

    Recruiting

  • Hospices Civils de lyon - Hôpital Edouard Herriot

    Lyon

    Antoine Millon

    Recruiting

  • Centre Hospitalier Universitaire de Rennes

    Rennes

    Adrien Kaladji

    Recruiting

Other trials in France

Germany4 sites, 3 recruiting

  • University Hospital RWTH Aachen

    Aachen, 52074

    Alexander Gombert

    Recruiting

  • University Hospital Leipzig

    Leipzig, 04109

    Dierk Scheinert

    Recruiting

  • Klinikum der Technischen Universität München

    München, 81675

    Branzan

    Recruiting

  • Martin Austermann

    Münster, 48145

    Completed

Other trials in Germany

Belgium3 sites, 3 recruiting

  • CRC thoracic Vascular Surgery, ZOL Genk

    Genk, 3600

    Wouter Lansink, Dr MD

    Recruiting

  • Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde

    Ghent, 9000

    Isabelle vanHerzeele

    Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500

    Du Pont

    Recruiting

Other trials in Belgium

Netherlands2 sites, 2 recruiting

  • VUMC Amsterdam

    Amsterdam

    Kak Khee Yeung

    Not yet recruiting

  • Catharina Ziekenhuis

    Eindhoven

    Philippe Cuypers

    Not yet recruiting

Other trials in Netherlands

Spain2 sites, 2 recruiting

  • Hospital Ramon Y Cajal

    Madrid

    Andrés Reyer

    Recruiting

  • HOSPITAL CLINICO UNIVERSITARIO Valladolid

    Valladolid, 47003

    Lourdes del Rio Sola

    Recruiting

Other trials in Spain

Austria1 site, 1 recruiting

  • Hospital Ottakring, Institute for Vascular Surgery

    Vienna, 1160

    Afshin Assadian

    Recruiting

Other trials in Austria

Poland1 site, 1 recruiting

  • National Institute of Cardiology Warzwa

    Warsaw, 04-628

    Piotr Szopinski

    Recruiting

Other trials in Poland

Switzerland1 site, 1 recruiting

  • Inselspital Bern, Universitätsklinik für Gefässchirurgie

    Bern, 3010

    Drosos Kotelis, Prof

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: 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).

Being tested
ESAR treatment: Endograft + Heli-FX Endoanchor, FEVAR treatment : Fenestrated endograft
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ESAR treatment: Endograft + Heli-FX EndoanchorDevice

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

  • FEVAR treatment : Fenestrated endograftDevice

    Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft

Study groups in NCT04503395
Study groupRoleWhat they receive
ESARExperimentalEndovascular Aneurysm Repair + Heli-FX EndoAnchors
Receives: Device: ESAR treatment: Endograft + Heli-FX Endoanchor
FEVARActive comparatorFenestrated EndoVascular Aneurysm Repair
Receives: Device: FEVAR treatment : Fenestrated endograft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through 12 months post-procedure

  2. 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

    Measured: through 30 days post-procedure

Secondary outcomes (15)

  1. Total contrast volume (ml) at index procedure

    Total contrast volume (mL) at index procedure

    Measured: at index procedure

  2. Total fluoroscopy time (minutes) at index procedure

    Total fluoroscopy time (minutes) at index procedure

    Measured: at index procedure

  3. Duration (minutes) of index procedure

    1. Duration (minutes) of index procedure (time between initial skin access to final closure of the last artery access site)

    Measured: at index procedure

  4. Adequate penetration of EndoAnchor implants as assessed by the Core Lab

    Adequate penetration of EndoAnchor implants as assessed by the Core Lab

    Measured: at index procedure

  5. Clinical success

    1. 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.

    Measured: through 30 days post-procedure

  6. 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

    Measured: through 1,12,24 and 36-months post-op

  7. 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

    Measured: through 1,12,24 and 36-months post-op

  8. 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

    Measured: through 1,12,24 and 36-months post-op

  9. 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

    Measured: through 1,12,24 and 36-months post-op

  10. 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

    Measured: through 12,24 and 36-months post-op

  11. 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

    Measured: through 12,24 and 36-months post-op

  12. 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

    Measured: through 1,12,24 and 36-months post-op

  13. 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

    Measured: through 1,12,24 and 36-months post-op

  14. 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

    Measured: through 1 and 12 months post-op

  15. 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.

    Measured: at 1-, 12-, 24- and 36-months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2020
  2. Study start21 May 2021
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
comparision of two different procedure to repair abdominal aortic aneurysms with short necks
Masking
None (open label)
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04503395
Sponsor's protocol ID
FCRE-191125
Acronym
SOCRATES
Status last verified
May 2026
First submitted
22 Jul 2020
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ESAR treatment: Endograft + Heli-FX Endoanchor and FEVAR treatment : Fenestrated endograft in people with Aortic Aneurysm, Abdominal, run by FCRE (Foundation for Cardiovascular Research and Education) at 33 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Italy, France, Germany, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karlotta Knuth (+4915785318893, info@fcre.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness Endpoint - Technical Success (time frame: through 12 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04503395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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