Aortic Aneurysm, Abdominal
Conditions
Keywords
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
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).
Detailed description
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.
Interventions
DEVICEendovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system
DEVICEendosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system
Sponsors
Rijnstate Hospital
Medtronic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint at on proximal seal outcomes | 1 year follow-up | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from type IA endoleak | 1 year follow-up | Freedom from type IA endoleak |
| Freedom from migration | 1 year follow-up | Migration of the proximal portion of the stent graft ≥5 mm (compared to 1-month imaging) |
| Freedom from aneurysm sac growth | 1 year follow-up | Aneurysm sac growth ≥5 mm (compared to 1-month imaging). |
| Freedom from neck dilatation ≥ 3 mm | 1 year follow-up | Neck dilatation ≥ 3 mm (compared to 1-month imaging). |
Countries
France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTSuzanne Holewijn, PhD
CONTACTDaphne van der Veen, MSc
PRINCIPAL_INVESTIGATORMMPJ Reijnen, Prof. Dr.
Rijnstate, Arnhem, the Netherlands
PRINCIPAL_INVESTIGATORK. Donas, Prof. Dr.
Asklepios Clinic Langen, Langen, Germany
Outcome results
None listed