Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

NCT04503395 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

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

Study Locations (20)

Other

  • Hospital Ottakring, Institute for Vascular Surgery — Vienna
  • CRC thoracic Vascular Surgery, ZOL Genk — Genk
  • Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde — Ghent
  • Amrois Paré Hospital (APHP) — Boulogne
  • Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert — Clermont-Ferrand
  • Hospices Civils de lyon - Hôpital Edouard Herriot — Lyon
  • Centre Hospitalier Universitaire de Rennes — Rennes
  • University Hospital RWTH Aachen — Aachen
  • University Hospital Leipzig — Leipzig
  • Martin Austermann — Münster

California

  • UCSD Medical Center Hillcrest — La Jolla
  • Stanford University — Stanford

Florida

  • University of Florida — Gainesville

Michigan

  • Corewell Health (Spectrum) — Grand Rapids

New York

  • Mount Sinai Hospital — New York

North Carolina

  • Atrium Health Carolinas Medical Center — Charlotte

Oklahoma

  • Oklahoma Heart — Tulsa

Oregon

  • Providence Portland Medical Center — Portland

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2021-05-21
Est. Completion 2028-06-01
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04503395

The ClinicalTrials.gov registry entry for NCT04503395 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is FCRE (Foundation for Cardiovascular Research and Education), which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Aortic Aneurysm, Abdominal appearing as the primary indexed condition, and to 2 interventions — of which ESAR treatment: Endograft + Heli-FX Endoanchor is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04503395 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04503395 about?

NCT04503395 is a clinical study titled "ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES". 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 aorti...

What is the current status of trial NCT04503395?

This trial is currently recruiting. It is a NA study. The enrollment target is 204 participants. The study started on 2021-05-21. Estimated completion is 2028-06-01.

What conditions does trial NCT04503395 study?

This clinical trial studies the following conditions: Aortic Aneurysm, Abdominal. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04503395?

The interventions under investigation include: ESAR treatment: Endograft + Heli-FX Endoanchor (DEVICE), FEVAR treatment : Fenestrated endograft (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04503395?

This trial is sponsored by FCRE (Foundation for Cardiovascular Research and Education), which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04503395 being conducted?

This trial has 20 study locations across California, Florida, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial