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Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
Sponsor: Rijnstate Hospital
Summary
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).
Official 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 (HERCULES Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-05-26
Completion Date
2033-04
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
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
Locations (37)
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
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 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