NCT05484115

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

Official Title:

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)

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

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

Disease(s) and\or Condition(s)

Aortic Aneurysm, Abdominal

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DEVICE
    • Name: endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
    • Description: treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system
    • Arm Group Labels: Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
    • Type: DEVICE
    • Name: endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
    • Description: treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system
    • Arm Group Labels: Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors
Sponsor
  • Rijnstate Hospital