Actively Recruiting
Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
Led by Rijnstate Hospital · Updated on 2026-05-11
300
Participants Needed
36
Research Sites
514 weeks
Total Duration
On this page
Sponsors
R
Rijnstate Hospital
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Provided written informed consent
- Clinical need for AAA treatment according to local guidelines
- Scheduled for elective repair
- Anatomy suitable for Endurant II/IIs stent graft and Heli-FX EndoAnchor use per device instructions
- Infrarenal neck diameter between 28 mm and 32 mm
- Proximal neck length of at least 10 mm
You will not qualify if you...
- Anatomy not suitable per device instructions for Endurant II/IIs stent graft or Heli-FX EndoAnchor
- Planned use of AUI main body device
- Participation in another clinical study that could affect outcomes
- Kidney function with eGFR less than 30 ml/min/1.73m2 before treatment
- Life expectancy less than 2 years as judged by the investigator
- Psychiatric or other conditions interfering with study participation
- Known allergy to any device components
- Systemic infection increasing risk of graft infection
- Coagulopathy or uncontrolled bleeding disorders
- Presence of ruptured, leaking, or infected aneurysm
- Not eligible for standard EVAR
- Stroke or heart attack within the past 3 months
- Pregnancy (for female participants of childbearing potential)
- Active COVID-19 infection or hospitalization for long COVID-19 within 6 months
- Previous treatment with stent grafts in the aorto-iliac arteries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
Washington Regional Medical Center
Washington, Arkansas, United States, 27962
Actively Recruiting
2
Mt Sinai Med Ctr
Miami Beach, Florida, United States, 33140
Actively Recruiting
3
Loyola
Maywood, Illinois, United States, 60153
Actively Recruiting
4
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Not Yet Recruiting
5
Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
6
Alina Health
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
7
University of Missouri
Columbia, Missouri, United States, 65211
Actively Recruiting
8
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Robert Wood Johnson University Medical Center
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
10
Sisters of Charity hospital
Buffalo, New York, United States, 14214
Actively Recruiting
11
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
12
NC Heart& Vascular
Raleigh, North Carolina, United States, 27607
Actively Recruiting
13
Promedica Toledo Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
14
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17036
Actively Recruiting
15
Ballad Health/Holston Valley
Kingsport, Tennessee, United States, 37660
Actively Recruiting
16
Virginia Commonwealth University (VCU)
Richmond, Virginia, United States, 23284
Actively Recruiting
17
HCL Lyon
Lyon, France, 69002
Actively Recruiting
18
Saint Joseph Marseille
Marseille, France, 13285
Actively Recruiting
19
Les Franciscaines
Nîmes, France, 30000
Actively Recruiting
20
Asklepios Klinik Langen
Langen, Hesse, Germany, 63225
Actively Recruiting
21
Universitatsklinikum Frankfurt
Frankfurt, Germany, 60596
Not Yet Recruiting
22
University Hospital Leipzig
Leipzig, Germany, 04103
Actively Recruiting
23
IRCCS Ospedale Policlinico San Martino
Genova, Metropolitan City of Genoa, Italy, 16132
Actively Recruiting
24
Osp. S.Orsola Malpighi - Bologna
Bologna, Italy, 40138
Actively Recruiting
25
Noordwest ziekenhuis
Alkmaar, North Holland, Netherlands, 1815 JD
Not Yet Recruiting
26
Spaarne Gasthuis
Haarlem, North Holland, Netherlands, 2000 AK
Not Yet Recruiting
27
Rijnstate hospital
Arnhem, Netherlands, 6815 AD
Actively Recruiting
28
Catharina Ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
29
Hospital Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
30
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Actively Recruiting
31
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Not Yet Recruiting
32
EHC-Hôpital de Morges
Morges, Switzerland, 1110
Actively Recruiting
33
Queen Elizabeth University Hospital, Glasgow
Glasgow, United Kingdom
Actively Recruiting
34
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
35
St. George's Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
36
St. Mary's Hospital
London, United Kingdom
Actively Recruiting
Research Team
S
Suzanne Holewijn, PhD
CONTACT
D
Daphne van der Veen, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here