Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck

Launched by RIJNSTATE HOSPITAL · Aug 1, 2022

Keywords

ClinConnect Summary

The HERCULES trial is a study that aims to compare two different methods for treating a type of blood vessel problem called an infrarenal abdominal aortic aneurysm (AAA). Specifically, it looks at endosuture aneurysm repair (ESAR) versus the standard method known as endovascular aneurysm repair (EVAR) in patients who have a wider section of the aorta at the top of the aneurysm. This trial is currently recruiting participants aged 18 and older who need treatment for their AAA and have certain measurements in their blood vessels, specifically a neck diameter between 28 mm and 32 mm.

To join the study, participants must meet specific criteria, such as being in good enough health for the procedure and having the right type of blood vessel anatomy for the devices used in the study. During the trial, participants can expect to receive either the ESAR or EVAR treatment, and their outcomes will be monitored to see which method works better. It's important for potential participants to know that those with certain health conditions or recent serious medical events may not be eligible. This research could help improve treatment options for people with similar aneurysms in the future.

Gender

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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