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

Study acronym: HERCULES
StatusRecruiting
PhaseNot applicable
Started2023-05-26
View on ClinicalTrials.gov ↗

Amendment history

2026-05-08
Study Status, Contacts/Locations v12
Study sites37→36
2026-03-16
Study Status, Contacts/Locations v11
Study sites36→37
2025-12-18
Study Status, Contacts/Locations v10
Study sites33→36
2025-11-18
Study Status, Contacts/Locations v9
Study sites27→33
2025-08-04
Study Status, Contacts/Locations v8
Study sitesdetails revised at 3 of 27 sites
Show 7 earlier versions
2025-03-17
Study Status, Oversight, Contacts/Locations v7
Primary completion date2027-06→2029-04
Completion date2031-12→2033-04
Study sites22→27
2024-06-12
Study Status, Contacts/Locations v6
Study sites15→22
2024-05-08
Study Status, Oversight, Contacts/Locations v5
Study sites3→15
2023-11-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-05→confirmed 2023-05-26
Study sites0→3
2023-04-24
Study Status, Outcome Measures v3
Secondary endpoints3 to 4 entries
Freedom from type IaIA endoleak freedomFreedom from aneurysm sac growth Freedom from neck dilatation ≥ 3 mm
2023-04-05
Study Status, Study Description, Study Design, Outcome Measures v2
Primary completion date2026-10→2027-06
Completion date2031-04→2031-12
Start date2022-10→2023-05
Secondary endpointsdetails revised at 3 of 3 entries
Primary endpoints1 entry, revised
Composite endpoint at one-year follow-up on proximal seal outcomes
Study description-4 characters
[...] ost-market, global, multicenter, randomized (1:1), two-arm, non-inferioritysuperiority trial Up to 300 subjects will be recruited in up to 40 site [...]
2022-08-05
Study Status, Study Description, Arms and Interventions v1
Interventionsendovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system (Device), endovascular sealing aneurysm repair (ESAR)…→endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system (Device), endovascular aneurysm repair (EVAR) using the Endurant II/IIs…
2022-08-01
Original filing
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).
Trial Details
NCT Number NCT05484115
Lead Sponsor Rijnstate Hospital
Collaborators: Medtronic
Conditions Aortic Aneurysm, Abdominal
Enrollment 300 participants
Start Date 2023-05-26
Primary Completion 2029-04 (estimated)
Study Completion 2033-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-11