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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
Devicetreatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system
endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
Devicetreatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft systemActive comparator 1 intervention
Group B: Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with EndoanchorsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite endpoint at on proximal seal outcomes
The primary endpoint is a composite endpoint based on core lab reported data from computed tomography (CT) with contrast imaging of freedom from: 1. type IA endoleak and 2. Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging) and 3. Aneurysm sac growth ≥5 mm (compared to 1-month imaging).
Time frame
1 year follow-upSecondary outcomes
1
Freedom from type IA endoleak
Freedom from type IA endoleak
Time frame
1 year follow-up2
Freedom from migration
Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging)
Time frame
1 year follow-up3
Freedom from aneurysm sac growth
Aneurysm sac growth ≥5 mm (compared to 1-month imaging).
Time frame
1 year follow-up4
Freedom from neck dilatation ≥ 3 mm
Neck dilatation ≥ 3 mm (compared to 1-month imaging).
Time frame
1 year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rijnstate Hospital
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov