Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
NCT ID: NCT05484115
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-05-26
2033-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system
Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors
endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system
Interventions
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endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system
endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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 has a ruptured, leaking, or mycotic aneurysm
* Patient is not eligible for standard EVAR
* Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI) within the prior three months
* Patient is pregnant (Female patients of childbearing potential only)
* 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
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Rijnstate Hospital
OTHER
Responsible Party
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Principal Investigators
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MMPJ Reijnen, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Rijnstate, Arnhem, the Netherlands
K. Donas, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Asklepios Clinic Langen, Langen, Germany
Locations
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Washington Regional Medical Center
Washington, Arkansas, United States
Mt Sinai Med Ctr
Miami Beach, Florida, United States
Loyola
Maywood, Illinois, United States
Henry Ford Hospital
Detroit, Michigan, United States
Beaumont University Hospital
Royal Oak, Michigan, United States
Alina Health
Minneapolis, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Robert Wood Johnson University Medical Center
New Brunswick, New Jersey, United States
Sisters of Charity hospital
Buffalo, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
NC Heart& Vascular
Raleigh, North Carolina, United States
Promedica Toledo Hospital
Toledo, Ohio, United States
Ballad Health/Holston Valley
Kingsport, Tennessee, United States
Virginia Commonwealth University (VCU)
Richmond, Virginia, United States
HCL Lyon
Lyon, , France
Saint Joseph Marseille
Marseille, , France
Les Franciscaines
Nîmes, , France
Asklepios Klinik Langen
Langen, Hesse, Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
University Hospital Leipzig
Leipzig, , Germany
IRCCS Ospedale Policlinico San Martino
Genova, Metropolitan City of Genoa, Italy
Osp. S.Orsola Malpighi - Bologna
Bologna, , Italy
Noordwest ziekenhuis
Alkmaar, North Holland, Netherlands
Spaarne Gasthuis
Haarlem, North Holland, Netherlands
Rijnstate hospital
Arnhem, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Ramon Y Cajal
Madrid, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
EHC-Hôpital de Morges
Morges, , Switzerland
Queen Elizabeth University Hospital, Glasgow
Glasgow, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
St. George's Hospital
London, , United Kingdom
St. Mary's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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P. Dr. Halandras, MD
Role: primary
Dr. Mitchel Weaver
Role: primary
Prof. Dr. med. Konstantinos Donas, MD PhD
Role: primary
Anja Bukvarevic
Role: backup
Prof. Dr. med. Kyriakos Oikonomou, Prof. MD
Role: primary
Tanja Dietrich
Role: backup
Dr. Schmidt, MD PhD
Role: primary
Steffi Anding
Role: backup
Prof. G. Pratesi
Role: primary
M Prof. Gargiulo, PhD
Role: primary
Dr. Cagdas Unlu
Role: primary
Dr. Maarten Truijers
Role: primary
Suzanne Holewijn, PhD
Role: primary
Daphne van der Veen, MSc
Role: backup
Ph.W.M. Cuypers
Role: primary
A. Dr. Reyes Valdivia, MD
Role: primary
Dr Gabriel C. Inaraja Perez
Role: primary
Dr Marzo Alvarez
Role: primary
P. Dr. Walker, MD
Role: primary
I Prof. Loftus, MD PhD
Role: primary
Other Identifiers
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2021-1968
Identifier Type: -
Identifier Source: org_study_id