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

RECRUITING NA

Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck

NCT05484115 · View on ClinicalTrials.gov ↗

Study Summary

The HERCULES trial is a Randomized controlled clinical trial designed to prospectively compare endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) clinical outcomes in treatment of infrarenal abdominal aortic aneurysm (AAA) in subjects having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm).

Conditions Studied

Interventions

  • DEVICE endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
  • DEVICE endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system

Study Locations (20)

Other

  • HCL Lyon — Lyon
  • Saint Joseph Marseille — Marseille
  • Les Franciscaines — Nîmes

Michigan

  • Henry Ford Hospital — Detroit
  • Beaumont University Hospital — Royal Oak

Missouri

  • University of Missouri — Columbia
  • Barnes-Jewish Hospital — St Louis

New York

  • Sisters of Charity hospital — Buffalo
  • Stony Brook University Medical Center — Stony Brook

Arkansas

  • Washington Regional Medical Center — Washington

Florida

  • Mt Sinai Med Ctr — Miami Beach

Illinois

  • Loyola — Maywood

Minnesota

  • Alina Health — Minneapolis

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2023-05-26
Est. Completion 2033-04
Phase NA

Sponsor

Rijnstate Hospital

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05484115

The ClinicalTrials.gov registry entry for NCT05484115 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 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rijnstate Hospital, which has 1 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 endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system 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: NCT05484115 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Michigan, Missouri. 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 NCT05484115 about?

NCT05484115 is a clinical study titled "Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck". The HERCULES trial is a Randomized controlled clinical trial designed to prospectively compare endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) clinical outcomes in treatment of infrarenal abdominal aortic aneurysm (AAA) in subjects having wide proximal aortic neck d...

What is the current status of trial NCT05484115?

This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2023-05-26. Estimated completion is 2033-04.

What conditions does trial NCT05484115 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 NCT05484115?

The interventions under investigation include: endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system (DEVICE), endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05484115?

This trial is sponsored by Rijnstate Hospital, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05484115 being conducted?

This trial has 20 study locations across Arkansas, Florida, Illinois, Michigan, Minnesota. 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