Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
ConditionAortic Aneurysm, Abdominal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRijnstate Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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 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
Trial design
Treatments tested in this trial
- endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
- endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rijnstate Hospital
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov