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

NCT05484115 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-11

No results posted yet for this 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

  • Aortic Aneurysm, Abdominal

Interventions

DEVICE

endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system

treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system

DEVICE

endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system

treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • MMPJ Reijnen, Prof. Dr. · Rijnstate, Arnhem, the Netherlands

  • K. Donas, Prof. Dr. · Asklepios Clinic Langen, Langen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-26
Primary Completion
2029-04-30
Completion
2033-04-30
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

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 NCT05484115 on ClinicalTrials.gov