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

Study Overview
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Brief Summary
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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).

Detailed Description
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HERCULES is an investigator driven trial and a collaborative research project with Medtronic. Design; Prospective, post-market, global, multicenter, randomized (1:1), two-arm, superiority trial Up to 300 subjects will be recruited in up to 40 sites in Europe and the US. All subjects shall be followed per local societal guidelines and per the Endurant II/IIs and Heli-FX EndoAnchor instruction for use (IFU) recommendations for post-implant follow-up and CT-imaging, with expected assessments at baseline, index procedure(s), 1-month, and annually at 1, 2, 3, 4, and 5 years post-index procedure. Devices used in HERCULES include the Endurant II/IIs stent graft system (EVAR arm) and the Endurant II/IIs stent graft system plus the Heli-FX EndoAnchor System (ESAR arm) This study is being conducted to collect clinical evidence from treatment of patients with infrarenal AAA having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm), comparing clinical outcomes with treatment of the AAA with the Endurant II/IIs stent graft in conjunction with Heli-FX EndoAnchors to treatment of the AAA with the Endurant II/IIs stent graft alone. Though both the Endurant II/IIs stent graft and Heli-FX EndoAnchors are commercially approved in this indication, clinical evidence comparing these two treatments in patients with wide proximal aortic neck diameters is not currently available. Collecting clinical data specific to this patient population, including procedure and imaging data as well as long term outcomes, will provide a foundation to further characterize the clinical outcomes of treatment for patients with infrarenal AAA with wide proximal aortic neck diameters.

Official Title
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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)

Conditions
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Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Device: endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
* Device: endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: HERCULES is a post-market, prospective, global, multicenter, randomized (1:1), two-arm, superiority trial designed to compare ESAR to standard EVAR clinical outcomes in treatment of infrarenal AAA in patients having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system<br> | Device: endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system<br>* treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system<br>|
| Active Comparator: Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors<br> | Device: endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system<br>* treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: type IA endoleak and Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging) and Aneurysm sac growth ≥5 mm (compared to 1-month imaging). | 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from type IA endoleak | Freedom from type IA endoleak | 1 year follow-up | 
| Freedom from migration | Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging) | 1 year follow-up | 
| Freedom from aneurysm sac growth | Aneurysm sac growth ≥5 mm (compared to 1-month imaging). | 1 year follow-up | 
| Freedom from neck dilatation ≥ 3 mm | Neck dilatation ≥ 3 mm (compared to 1-month imaging). | 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AAA, Endovascular treatment, Wide proximal neck, EndoAnchors, Infrarenal, EVAR (Endovascular aneurysm repair), ESAR (Endosuture aneurysm repair), Endurant II/IIs stent graft system, Heli-FX EndoAnchor system