ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
NCT ID: NCT04503395
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
204 participants
INTERVENTIONAL
2021-05-21
2028-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
NCT05484115
Outcomes of FEVAR and BEVAR to Treat Secondary Type 1 Endoleak After EVAR: A Prospective Multicentre Study
NCT04532450
Evaluation of the Treatment of Abdominal Aortic Pathology With Hostile Necks, Para-/Juxra-renal and Sovrarenal Pathology at Short, Mid and Long Term
NCT03608683
Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair
NCT00118573
Endovascular Aneurysm Repair (EVAR) Gate Study
NCT02934087
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ESAR
Endovascular Aneurysm Repair + Heli-FX EndoAnchors
ESAR treatment: Endograft + Heli-FX Endoanchor
ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
FEVAR
Fenestrated EndoVascular Aneurysm Repair
FEVAR treatment : Fenestrated endograft
Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ESAR treatment: Endograft + Heli-FX Endoanchor
ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
FEVAR treatment : Fenestrated endograft
Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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°
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic
INDUSTRY
FCRE (Foundation for Cardiovascular Research and Education)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marc Bosiers, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giovanni Torsello, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Vascupedia
Brant Ullery, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Medical Director, Vascular Surgery Providence Heart and Vascular Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCSD Medical Center Hillcrest
La Jolla, California, United States
Stanford University
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
Corewell Health (Spectrum)
Grand Rapids, Michigan, United States
Mount Sinai Hospital
New York, New York, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
Oklahoma Heart
Tulsa, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Hospital Ottakring, Institute for Vascular Surgery
Vienna, , Austria
CRC thoracic Vascular Surgery, ZOL Genk
Genk, , Belgium
Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde
Ghent, , Belgium
Amrois Paré Hospital (APHP)
Boulogne, , France
Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert
Clermont-Ferrand, , France
Hospices Civils de lyon - Hôpital Edouard Herriot
Lyon, , France
Centre Hospitalier Universitaire de Rennes
Rennes, , France
University Hospital RWTH Aachen
Aachen, , Germany
University Hospital Leipzig
Leipzig, , Germany
Martin Austermann
Münster, , Germany
University of Bologna, IRCCS S. Orsola Hospital,
Bologna, , Italy
Az. Ospedaliera San Martino, Genova
Genova, , Italy
IRCCS Ospedale San Raffaele, Chirurgia Vascolare
Milan, , Italy
Vascular Endovascular Surgery University of Perugia;
Perugia, , Italy
Az.Osped.Univers.S.Giovanni, Turin
Turin, , Italy
VUMC Amsterdam
Amsterdam, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
National Institute of Cardiology Warzwa
Warsaw, , Poland
Hospital Ramon Y Cajal
Madrid, , Spain
Hospital Universitario Donostia
San Sebastián, , Spain
HOSPITAL CLINICO UNIVERSITARIO Valladolid
Valladolid, , Spain
Inselspital Bern, Universitätsklinik für Gefässchirurgie
Bern, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jason Lee
Role: primary
Rami Tadros
Role: primary
Frank Arko
Role: primary
Adel Barkat
Role: primary
Hosam El-Sayed
Role: primary
Afshin Assadian
Role: primary
Wouter Lansink, Dr MD
Role: primary
Isabelle vanHerzeele
Role: primary
Raphael Coscas
Role: primary
Fabien Thaveau
Role: primary
Antoine Millon
Role: primary
Adrien Kaladji
Role: primary
Alexander Gombert
Role: primary
Dierk Scheinert
Role: primary
Mauro Gargiulo, Prof
Role: primary
Giovanni Pratesi
Role: primary
Andrea Kahlberg, Prof
Role: primary
Massimo Lenti, Prof MD
Role: primary
Giacomo Isernia, MD, PHD
Role: backup
Fabio Verzini
Role: primary
Kak Khee Yeung
Role: primary
Philippe Cuypers
Role: primary
Piotr Szopinski
Role: primary
Andrés Reyer
Role: primary
Mariano de Blas
Role: primary
Lourdes del Rio Sola
Role: primary
Drosos Kotelis, Prof
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FCRE-191125
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.