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

May 20, 2026 updated by: Marc Bosiers, MD, FCRE (Foundation for Cardiovascular Research and Education)

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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 Édouard 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness Endpoint - Technical Success
Time Frame: through 12 months post-procedure
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
Time Frame: through 30 days post-procedure
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total contrast volume (ml) at index procedure
Time Frame: at index procedure
Total contrast volume (mL) at index procedure
at index procedure
Total fluoroscopy time (minutes) at index procedure
Time Frame: at index procedure
Total fluoroscopy time (minutes) at index procedure
at index procedure
Duration (minutes) of index procedure
Time Frame: at 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
Time Frame: through 30 days post-procedure
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
Time Frame: through 1,12,24 and 36-months post-op
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
Time Frame: 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
through 1,12,24 and 36-months post-op
Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up
Time Frame: through 1,12,24 and 36-months post-op
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
Time Frame: through 1,12,24 and 36-months post-op
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
Time Frame: through 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
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
Time Frame: 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
through 12,24 and 36-months post-op
Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up
Time Frame: through 1,12,24 and 36-months post-op
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
Time Frame: through 1,12,24 and 36-months post-op
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
Time Frame: through 1 and 12 months post-op
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
Time Frame: at 1-, 12-, 24- and 36-months follow-up
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
Time Frame: at index procedure
Adequate penetration of EndoAnchor implants as assessed by the Core Lab
at index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FCRE (Foundation for Cardiovascular Research and Education)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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