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)
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).
Description
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.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Deviceendovascular 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
- Deviceendosuture 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 CenterWashington, Arkansas
- Mt Sinai Med CtrMiami Beach, Florida
- LoyolaMaywood, Illinois
- Henry Ford HospitalDetroit, Michigan
- Beaumont University HospitalRoyal Oak, Michigan
- Alina HealthMinneapolis, Minnesota