Last reviewed · How we verify
NCT05484115: HERCULES
Randomized Controlled Clinical Trial on the Application of Heli-FX EndoAnchors in Conjunction With the Endurant II/IIs Endograft in Infrarenal Aortic Aneurysms With a Wide Infrarenal Neck (HERCULES Trial)
NA trial testing endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system in Aortic Aneurysm, Abdominal in 300 participants. Currently enrolling.
1 April 2029
Quick facts
| Lead sponsor | Rijnstate Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 26 May 2023 |
| Primary completion | 1 April 2029 |
| Estimated completion | 1 April 2033 |
| Sites | 36 locations across United States, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom |
Drugs / interventions tested
- endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
- endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
Conditions studied
- Aortic Aneurysm, Abdominal — all drugs for Aortic Aneurysm, Abdominal →
Sponsor
Rijnstate Hospital
Who can join
18 and older, any sex, with Aortic Aneurysm, Abdominal. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Composite endpoint at on proximal seal outcomes
Time frame: 1 year follow-up
The primary endpoint is a composite endpoint based on core lab reported data from computed tomography (CT) with contrast imaging of freedom from: 1. type IA endoleak and 2. Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging) and 3. Aneurysm sac growth ≥5 mm (compared to 1-month imaging).
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm with a Wide or Conical-Shaped Infrarenal Neck Anatomy.
Plug M, Holewijn S, Meershoek A, van der Veen D, et al · · 2025 · PMID 40565878 · DOI 10.3390/jcm14124133
Verify or expand the search:
- PubMed search for NCT05484115
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Aortic Aneurysm, Abdominal
Currently open trials in the same condition.
- NCT06488898 — Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts · Phase 2 · recruiting
- NCT05972018 — Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters · Phase 4 · recruiting
- NCT04503395 — ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES · NA · recruiting
- NCT05360108 — Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm · active not recruiting
- NCT02489539 — Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms · NA · active not recruiting
Other Rijnstate Hospital trials
Trials by the same sponsor.
- NCT07070583 — Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure · NA · recruiting
- NCT07304401 — Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induce · recruiting
- NCT06883591 — Triaxial Accelerometry Study · active not recruiting
- NCT06827509 — Blood Flow Evaluation After Carotid Surgical Treatment · not yet recruiting
- NCT05633550 — Flexion-Extension Radiograph Imaging Protocol Reliability Study · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05484115 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rijnstate Hospital
- Last refreshed: 8 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05484115.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing