Rijnstate Hospital
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).
HERCULES is an investigator driven trial and a collaborative research project with Medtronic. 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.…
Inclusion Criteria: * 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 Exclusion Criteria: * Anatomy outside the IFU of the ndurant II/IIs stent graft system and Heli-FX EndoAnchor system * Planned use of AUI main body device * Patient…
treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system
treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system