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ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

NCT04503395 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-05-22

No results posted yet for this 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).

Conditions

  • Aortic Aneurysm, Abdominal

Interventions

DEVICE

ESAR treatment: Endograft + Heli-FX Endoanchor

ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor

DEVICE

FEVAR treatment : Fenestrated endograft

Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • FCRE (Foundation for Cardiovascular Research and Education)

    lead OTHER

Principal Investigators

  • Giovanni Torsello, Prof. Dr. · Vascupedia

  • Brant Ullery, MD, MBA · Medical Director, Vascular Surgery Providence Heart and Vascular Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2026-06-01
Completion
2032-06-01
FDA Device
Yes

Countries

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04503395 on ClinicalTrials.gov