ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
Other trials for the same condition
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