HERCULES Trial
Research type
Research Study
Full 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.
IRAS ID
328552
Contact name
Colin Bicknell
Contact email
Sponsor organisation
Rijnstate
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 11 months, 31 days
Research summary
The HERCULES Trial is designed to compare the clinical outcomes in treatment of patients with infrarenal abdominal aortic aneurysm (located below the kidneys), who have a wide proximal aortic neck (diameter between 28-32mm).
It is a randomised study where patients will be equally split into one of two treatment groups. 1 group of patients will receive standard Endovascular Aneurysm Repair (EVAR) with the Endurant II/IIs endograft and the other group will receive Endosuture Aneurysm Repair with Endurant II/IIs in conjunction with Heli-FX EndoAnchors.
The HERCULES trial is a post-market study that will take place in approximately 40 centres across a range of countries. The study will aim to enrol up to 300 participants that will be followed up for 5 years following their surgery. Participants will receive CT imaging scans with contrast every year for their 5 year follow-up. These scans will be reviewed by an independent screening committee for the primary and secondary study endpoints.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0270
Date of REC Opinion
31 Jan 2024
REC opinion
Further Information Favourable Opinion