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Two repair methods for abdominal aortic aneurysm with a wide neck

Compares standard stent graft repair with added anchors for abdominal aortic aneurysm.

Key facts

Who runs it
Rijnstate Hospital
Where
Glasgow, Leeds, and London, United KingdomSee the 4 sitesAlso in 7 other countries, 32 sites
Trial code
Registry title
Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
Status
Recruiting
People taking part
300 people, planned
Started
26 May 2023
Expected to end
Apr 2033
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
  • endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
Record updated
11 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with an abdominal aortic aneurysm below the kidneys and a wide aortic neck. It compares standard stent graft repair (EVAR) with stent graft repair plus EndoAnchors (ESAR).

Age
18 years or older
Sex
All sexes
Disease stage
Infrarenal abdominal aortic aneurysm that needs planned (not emergency) repair. Neck diameter ≥ 28 mm and ≤32 mm, neck length ≥10mm. Anatomy must fit the instructions for use of the Endurant II/IIs stent graft system and Heli-FX EndoAnchor system.
Earlier treatment
People cannot join if they have had stent grafts in the aorto-iliac arteries before.

Main reasons for not taking part

  • Ruptured, leaking or infected (mycotic) aneurysm
  • Kidney function with eGFR < 30 ml/min/1.73m2
  • Stroke or heart attack within the prior three months
  • Life expectancy <2 years, bleeding disorder, or systemic infection
  • Pregnancy, or active COVID-19 or long COVID-19 needing hospital care within 6 months

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Age 18 years or older
  • Provided written informed consent
  • Clinical necessity for treatment of the AAA, according to the current guidelines in the geographies participating
  • Elective repair
  • Eligible anatomy for treatment with the Endurant II/IIs stent graft system and Heli-FX EndoAnchor system according to the IFU of both devices
  • Infrarenal neck diameter ≥ 28 mm and ≤32 mm
  • Proximal neck length ≥10mm

Who cannot take part

  • Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI) within the prior three months
  • Patient has active COVID-19 infection or has been diagnosed with long COVID-19 requiring hospitalization within the 6 months prior to procedure
  • Patient has previously been treated with stent grafts in the aorto-iliac arteries
  • Patient has a psychiatric or other condition that may interfere with the study
  • Patient has a known allergy to any device component
  • Patients with a systemic infection who may be at increased risk of endovascular graft infection
  • Patient has a coagulopathy or uncontrolled bleeding disorder
  • Patient with eGFR < 30 ml/min/1.73m2 before the intervention
  • Patient's life expectancy <2 years as judged by the investigator
  • Anatomy outside the IFU of the ndurant II/IIs stent graft system and Heli-FX EndoAnchor system
  • Planned use of AUI main body device
  • Patient is participating in another clinical study, potentially conflicting with the outcomes of the current study
  • Patient has a ruptured, leaking, or mycotic aneurysm
  • Patient is not eligible for standard EVAR
  • Patient is pregnant (Female patients of childbearing potential only)

Where in United Kingdom

Also in 7 other countries, 32 sites

  • Queen Elizabeth University Hospital GlasgowGlasgow, United KingdomContact: M Hennessy, MD (principal investigator)Taking people
  • Leeds General InfirmaryLeeds, United KingdomContact: P. Dr. Walker, MDTaking people
  • St Mary's HospitalLondon, United KingdomContact: C. Bicknell, MD (principal investigator)Taking people
  • St. George's HospitalLondon, United KingdomContact: I Prof. Loftus, MD PhDTaking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft systemExisting treatment, for comparison

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

  • Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with EndoanchorsExisting treatment, for comparison

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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)
Plain-language title
Two repair methods for abdominal aortic aneurysm with a wide neckGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
11 May 2026