At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system (device), endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system (device)
- How long the study runs
- Study runs about 119 months (dates as stated)
- About the drug or intervention
- endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system — device: treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system · endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system — device: treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system
- Patient visit burden
- Not specified by the sponsor
In plain English
This study compares two ways of repairing a swelling in the body's main artery in the tummy (an abdominal aortic aneurysm) that has a short or wide section at the top. One method is standard keyhole repair using a tube called a stent graft (known as EVAR, or endovascular aneurysm repair). The other uses the same stent graft plus small anchors (called EndoAnchors) to help hold it in place (known as ESAR). The study is being run by Rijnstate Hospital.
Who can take part
- Adults aged 18 or over
- Have given written permission (consent) to take part
- Need planned (non-emergency) treatment for their aneurysm, following local guidelines
- Have an aneurysm shape that suits both the Endurant II/IIs stent graft and the Heli-FX EndoAnchor devices, as set out in the makers' instructions
- The section (neck) of the artery near the kidneys is between 28 and 32 mm wide
- That neck section is at least 10 mm long
Who may not be able to
- An aneurysm shape that does not suit the two devices
- Plans to use a special one-legged stent graft (called an AUI main body device)
- Taking part in another clinical study that could affect this study's results
- Severe kidney problems (eGFR below 30) before the procedure
- Life expectancy of under 2 years, in the researcher's view
- A mental health or other condition that could interfere with the study
- An allergy to any part of the devices
- A body-wide infection that could raise the risk of the graft becoming infected
- A blood clotting problem or uncontrolled bleeding disorder
- An aneurysm that has burst, is leaking, or is infected
- Not suitable for standard EVAR
- A stroke or heart attack in the past 3 months
- Pregnancy
- Active COVID-19 infection, or long COVID needing a hospital stay in the 6 months before the procedure
- Previous stent graft treatment in the aorta or the arteries to the hips
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2023-05-26
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for aortic aneurysm, abdominal
- • NA - 300 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with aortic aneurysm, abdominal
Where?
- • Glasgow - Queen Elizabeth University Hospital, Glasgow
- • Leeds - Leeds General Infirmary
- • London - St. George's Hospital
- • London - St. Mary's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
HERCULES is an investigator driven trial and a collaborative research project with Medtronic. Design; Prospective, post-market, global, multicenter, randomized (1:1), two-arm, superiority trial Up to 300 subjects will be recruited in up to 40 sites in Europe and the US. All subjects shall be followed per local societal guidelines and per the Endurant II/IIs and Heli-FX EndoAnchor instruction for use (IFU) recommendations for post-implant follow-up and CT-imaging, with expected assessments at baseline, index procedure(s), 1-month, and annually at 1, 2, 3, 4, and 5 years post-index procedure. Devices used in HERCULES include the Endurant II/IIs stent graft system (EVAR arm) and the Endurant II/IIs stent graft system plus the Heli-FX EndoAnchor System (ESAR arm) This study is being conducted to collect clinical evidence from treatment of patients with infrarenal AAA having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm), comparing clinical outcomes with treatment of the AAA with the Endurant II/IIs stent graft in conjunction with Heli-FX EndoAnchors to treatment of the AAA with the Endurant II/IIs stent graft alone. Though both the Endurant II/IIs stent graft and Heli-FX EndoAnchors are commercially approved in this indication, clinical evidence comparing these two treatments in patients with wide proximal aortic neck diameters is not currently available. Collecting clinical data specific to this patient population, including procedure and imaging data as well as long term outcomes, will provide a foundation to further characterize the clinical outcomes of treatment for patients with infrarenal AAA with wide proximal aortic neck diameters.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Age 18 years or older
- ✓Provided written agreement to take part
- ✓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...
Who cannot take part
- ✗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 with eGFR \< 30 ml/min/1.73m2 before the intervention
- ✗Patient's life expectancy \<2 years as judged by the investigator
See the full criteria
Where Is This Study? (4 UK sites)
Queen Elizabeth University Hospital, Glasgow
Glasgow, United Kingdom
Leeds General Infirmary
Leeds LS1 3EX, United Kingdom
St. George's Hospital
London SW17 0QT, United Kingdom
St. Mary's Hospital
London, United Kingdom
How to Get in Touch
Suzanne Holewijn, PhD
Sponsor contactCONTACT
Daphne van der Veen, MSc
Sponsor contactCONTACT