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Recruiting Not applicable

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

NCT04503395 · tracked via the Priya Life Science Spain tracker
Sponsor
FCRE (Foundation for Cardiovascular Research and Education)
Phase
Not applicable
Started
2021-05-21
Last updated
2026-05-22

Condition(s) studied

Aortic Aneurysm, Abdominal

Investigational drug(s) / intervention(s)

ESAR treatment: Endograft + Heli-FX EndoanchorFEVAR treatment : Fenestrated endograft

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Effectiveness Endpoint - Technical Success — 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.
  • Safety Endpoint - Freedom from Major Adverse Events — 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

Trial sites (33)

FacilityCityRegionStatus
UCSD Medical Center Hillcrest La Jolla California Recruiting
Stanford University Stanford California Recruiting
University of Florida Gainesville Florida Recruiting
Corewell Health (Spectrum) Grand Rapids Michigan Recruiting
Mount Sinai Hospital New York New York Recruiting
Oklahoma Heart Tulsa Oklahoma Recruiting
Providence Portland Medical Center Portland Oregon Recruiting
Allegheny General Hospital Pittsburgh Pennsylvania Recruiting
Sentara Norfolk General Hospital Norfolk Virginia Recruiting
Hospital Ottakring, Institute for Vascular Surgery Vienna Austria Recruiting
CRC thoracic Vascular Surgery, ZOL Genk Genk Belgium Recruiting
Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde Ghent Belgium Recruiting
Jessa Ziekenhuis Hasselt Belgium Recruiting
Amrois Paré Hospital (APHP) Boulogne France Recruiting
Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert Clermont-Ferrand 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 Germany Recruiting
University Hospital Leipzig Leipzig Germany Recruiting
Klinikum der Technischen Universität München München Germany Recruiting
Martin Austermann Münster Germany Completed
University of Bologna, IRCCS S. Orsola Hospital, Bologna Italy Recruiting
Az. Ospedaliera San Martino, Genova Genova Italy Recruiting
IRCCS Ospedale San Raffaele, Chirurgia Vascolare Milan Italy Recruiting
Vascular Endovascular Surgery University of Perugia; Perugia Italy Not Yet Recruiting
Az.Osped.Univers.S.Giovanni, Turin Turin Italy Recruiting
Azienda Ospedaliera Universitaria Integrata di Verona Verona Italy Recruiting
VUMC Amsterdam Amsterdam Netherlands Not Yet Recruiting
Catharina Ziekenhuis Eindhoven Netherlands Not Yet Recruiting
National Institute of Cardiology Warzwa Warsaw Poland Recruiting
Hospital Ramon Y Cajal Madrid Spain Recruiting
HOSPITAL CLINICO UNIVERSITARIO Valladolid Valladolid Spain Recruiting
Inselspital Bern, Universitätsklinik für Gefässchirurgie Bern Switzerland Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04503395 on ClinicalTrials.gov ↗ ← All trials in Spain