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)
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years or older
• 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
Locations
United States
Arkansas
Washington Regional Medical Center
RECRUITING
Washington
Florida
Mt Sinai Med Ctr
RECRUITING
Miami Beach
Illinois
Loyola
RECRUITING
Maywood
Michigan
Beaumont University Hospital
RECRUITING
Royal Oak
Minnesota
Alina Health
RECRUITING
Minneapolis
Missouri
University of Missouri
RECRUITING
Columbia
Barnes-Jewish Hospital
RECRUITING
St Louis
North Carolina
NC Heart& Vascular
RECRUITING
Raleigh
New Jersey
Robert Wood Johnson University Medical Center
RECRUITING
New Brunswick
New York
Sisters of Charity hospital
RECRUITING
Buffalo
Stony Brook University Medical Center
RECRUITING
Stony Brook
Ohio
Promedica Toledo Hospital
RECRUITING
Toledo
Tennessee
Ballad Health/Holston Valley
RECRUITING
Kingsport
Virginia
Virginia Commonwealth University (VCU)
RECRUITING
Richmond
Other Locations
France
HCL Lyon
RECRUITING
Lyon
Saint Joseph Marseille
RECRUITING
Marseille
Les Franciscaines
RECRUITING
Nîmes
Italy
Osp. S.Orsola Malpighi - Bologna
RECRUITING
Bologna
Netherlands
Rijnstate hospital
RECRUITING
Arnhem
Catharina Ziekenhuis
RECRUITING
Eindhoven
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Ramon Y Cajal
RECRUITING
Madrid
Switzerland
EHC-Hôpital de Morges
RECRUITING
Morges
United Kingdom
Queen Elizabeth University Hospital, Glasgow
RECRUITING
Glasgow
Leeds General Infirmary
RECRUITING
Leeds
St. George's Hospital
RECRUITING
London
St. Mary's Hospital
RECRUITING
London
Contact Information
Primary
Suzanne Holewijn, PhD
herculestrial@rijnstate.nl
0031880057282
Backup
Daphne van der Veen, MSc
herculestrial@rijnstate.nl
0031880057282
Time Frame
Start Date: 2023-05-26
Estimated Completion Date: 2033-04
Participants
Target number of participants: 300
Treatments
Active_comparator: Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
Active_comparator: Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors
Related Therapeutic Areas
Sponsors
Leads: Rijnstate Hospital
Collaborators: Medtronic