Actively Recruiting
Randomized Controlled Trial of Heli-FX EndoAnchors with Endurant II/IIs Endograft for Infrarenal Aortic Aneurysms with Wide Neck
Led by Rijnstate Hospital · Updated on 2026-05-11
300
Participants Needed
36
Research Sites
208 weeks
Total Duration
On this page
Sponsors
R
Rijnstate Hospital
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for infrarenal abdominal aortic aneurysm (AAA) with wide proximal aortic neck diameters (28mm to 32mm). The trial compares clinical outcomes of two methods: endosuture aneurysm repair (ESAR) and standard endovascular aneurysm repair (EVAR). This randomized controlled trial aims to provide clinical evidence about the effectiveness of these approaches in patients with this specific aneurysm anatomy, addressing a current lack of comparative data. The study involves two groups: one receiving EVAR using the Endurant II/IIs stent graft system alone, and the other receiving ESAR with the Endurant II/IIs stent graft plus the Heli-FX EndoAnchor system. Up to 300 participants will be enrolled across multiple sites in Europe and the US. Participants will be followed according to recommended guidelines and device instructions, with assessments at baseline, the procedure, 1 month, and annually for up to 5 years. During the study, participants will undergo clinical evaluations including CT imaging and other assessments at scheduled visits. Researchers will measure outcomes such as the composite proximal seal success at 1 year, freedom from type IA endoleak, migration, aneurysm sac growth, and neck dilatation. Safety and long-term effectiveness will be monitored through these follow-ups, providing detailed information about the treatments over time.
CONDITIONS
Brief 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 necessity for AAA treatment per local guidelines
- Elective repair planned
- Eligible anatomy for Endurant II/IIs stent graft and Heli-FX EndoAnchor 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 outside device instructions for use
- Planned use of AUI main body device
- Participation in another conflicting clinical study
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2 before intervention
- Life expectancy less than 2 years
- Psychiatric or other condition interfering with study participation
- Known allergy to any device component
- Systemic infection increasing graft infection risk
- Coagulopathy or uncontrolled bleeding disorder
- Ruptured, leaking, or infected aneurysm
- Not eligible for standard EVAR
- Stroke or heart attack within prior three months
- Pregnancy (for females of childbearing potential)
- Active COVID-19 infection or recent long COVID requiring hospitalization
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Index procedure day
Participants undergo endovascular aneurysm repair using either the Endurant II/IIs stent graft system alone or with the Heli-FX EndoAnchor system to treat their infrarenal abdominal aortic aneurysm.
1 procedure visit (in-person)
Duration - Up to 5 years
Participants are followed with imaging and clinical assessments to monitor their recovery and the outcomes of the aneurysm repair.
1 baseline visit, 1 follow-up visit at 1 month, then annual visits at years 1 through 5
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
D
Daphne van der Veen, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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