NCT05484115 Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
| NCT ID | NCT05484115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rijnstate Hospital |
| Condition | Aortic Aneurysm, Abdominal |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-05-26 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-05-26 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 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 * Patient's life expectancy \<2 years as judged by the investigator * Patient has a psychiatric or other condition that may interfere with the study * Patient has a known allergy to any device component * Patients with a systemic infection who may be at increased risk of endovascular graft infection. * Patient has a coagulopathy or uncontrolled bleeding disorder * Patient has a ruptured, leaking, or mycotic aneurysm * Patient is not eligible for standard EVAR * Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI) within the prior three months * Patient is pregnant (Female patients of childbearing potential only) * Patient has active COVID-19 infection or has been diagnosed with long COVID-19 requiring hospitalization within the 6 months prior to procedure. * Patient has previously been treated with stent grafts in the aorto-iliac arteries
Contact & Investigator
MMPJ Reijnen, Prof. Dr.
PRINCIPAL INVESTIGATOR
Rijnstate, Arnhem, the Netherlands
Frequently Asked Questions
Who can join the NCT05484115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Aneurysm, Abdominal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05484115 currently recruiting?
Yes, NCT05484115 is actively recruiting participants. Contact the research team at herculestrial@rijnstate.nl for enrollment information.
Where is the NCT05484115 trial being conducted?
This trial is being conducted at Washington, United States, Miami Beach, United States, Maywood, United States, Detroit, United States and 11 additional locations.
Who is sponsoring the NCT05484115 clinical trial?
NCT05484115 is sponsored by Rijnstate Hospital. The principal investigator is MMPJ Reijnen, Prof. Dr. at Rijnstate, Arnhem, the Netherlands. The trial plans to enroll 300 participants.