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Studies

Interventional Recruiting

NCT04503395 on ClinicalTrials.gov

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

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

  • Sponsor: FCRE (Foundation for Cardiovascular Research and Education)
  • Collaborators: Medtronic
  • Enrollment: 204 (Estimated)
  • Study start: 2021-05-21 (Actual)
  • Primary completion: 2026-06-01 (Estimated)
  • Study completion: 2032-06-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: comparision of two different procedure to repair abdominal aortic aneurysms with short necks
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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).

Conditions

  • Aortic Aneurysm, Abdominal

Intervention / Treatment

  • Device: ESAR treatment: Endograft + Heli-FX Endoanchor
  • Device: FEVAR treatment : Fenestrated endograft

Primary Outcome Measures

  • 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

Countries

Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United States

Locations and Investigators

  • UCSD Medical Center Hillcrest, La Jolla, United States (Recruiting)
  • Stanford University, Stanford, United States (Recruiting)
    • Jason Lee
  • University of Florida, Gainesville, United States (Recruiting)
  • Corewell Health (Spectrum), Grand Rapids, United States (Recruiting)
  • Mount Sinai Hospital, New York, United States (Recruiting)
    • Rami Tadros
  • Oklahoma Heart, Tulsa, United States (Recruiting)
    • Adel Barkat
  • Providence Portland Medical Center, Portland, United States (Recruiting)
  • Allegheny General Hospital, Pittsburgh, United States (Recruiting)
  • Sentara Norfolk General Hospital, Norfolk, United States (Recruiting)
    • Hosam El-Sayed
  • Hospital Ottakring, Institute for Vascular Surgery, Vienna, Austria (Recruiting)
    • Afshin Assadian
  • CRC thoracic Vascular Surgery, ZOL Genk, Genk, Belgium (Recruiting)
    • Wouter Lansink, Dr MD
  • Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde, Ghent, Belgium (Recruiting)
    • Isabelle vanHerzeele
  • Jessa Ziekenhuis, Hasselt, Belgium (Recruiting)
    • Du Pont
  • Amrois Paré Hospital (APHP), Boulogne, France (Recruiting)
  • Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert, Clermont-Ferrand, France (Recruiting)
    • Fabien Thaveau
  • Hospices Civils de lyon - Hôpital Edouard Herriot, Lyon, France (Recruiting)
    • Antoine Millon
  • Centre Hospitalier Universitaire de Rennes, Rennes, France (Recruiting)
  • University Hospital RWTH Aachen, Aachen, Germany (Recruiting)
  • University Hospital Leipzig, Leipzig, Germany (Recruiting)
    • Dierk Scheinert
  • Klinikum der Technischen Universität München, München, Germany (Recruiting)
    • Branzan
  • Martin Austermann, Münster, Germany (Completed)
  • University of Bologna, IRCCS S. Orsola Hospital,, Bologna, Italy (Recruiting)
    • Mauro Gargiulo, Prof
  • Az. Ospedaliera San Martino, Genova, Genova, Italy (Recruiting)
    • Giovanni Pratesi
  • IRCCS Ospedale San Raffaele, Chirurgia Vascolare, Milan, Italy (Recruiting)
    • Andrea Kahlberg, Prof
  • Vascular Endovascular Surgery University of Perugia;, Perugia, Italy (Not yet recruiting)
    • Massimo Lenti, Prof MD
    • Giacomo Isernia, MD, PHD
  • Az.Osped.Univers.S.Giovanni, Turin, Turin, Italy (Recruiting)
    • Fabio Verzini
  • Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy (Recruiting)
    • Veraldi
  • VUMC Amsterdam, Amsterdam, Netherlands (Not yet recruiting)
    • Kak Khee Yeung
  • Catharina Ziekenhuis, Eindhoven, Netherlands (Not yet recruiting)
    • Philippe Cuypers
  • National Institute of Cardiology Warzwa, Warsaw, Poland (Recruiting)
    • Piotr Szopinski
  • Hospital Ramon Y Cajal, Madrid, Spain (Recruiting)
    • Andrés Reyer
  • HOSPITAL CLINICO UNIVERSITARIO Valladolid, Valladolid, Spain (Recruiting)
    • Lourdes del Rio Sola
  • Inselspital Bern, Universitätsklinik für Gefässchirurgie, Bern, Switzerland (Not yet recruiting)
    • Drosos Kotelis, Prof

Study Officials

  • Giovanni Torsello, Prof. Dr. (Principal Investigator) — Vascupedia
  • Brant Ullery, MD, MBA (Principal Investigator) — Medical Director, Vascular Surgery Providence Heart and Vascular Institute