Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
- Conditions
- Aortic Aneurysm, Abdominal
- Interventions
- Device: endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor systemDevice: endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
- Registration Number
- NCT05484115
- Lead Sponsor
- Rijnstate Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system - Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 type IA endoleak 1 year follow-up Freedom from type IA endoleak
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).
Trial Locations
- Locations (27)
Loyola
🇺🇸Maywood, Illinois, United States
Osp. S.Orsola Malpighi - Bologna
🇮🇹Bologna, Italy
Hospital Ramon Y Cajal
🇪🇸Madrid, Spain
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
St. George's Hospital
🇬🇧London, United Kingdom
Washington Regional Medical Center
🇺🇸Washington, Arkansas, United States
Mt Sinai Med Ctr
🇺🇸Miami Beach, Florida, United States
Beaumont University Hospital
🇺🇸Royal Oak, Michigan, United States
Alina Health
🇺🇸Minneapolis, Minnesota, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Robert Wood Johnson University Medical Center
🇺🇸New Brunswick, New Jersey, United States
Sisters of Charity hospital
🇺🇸Buffalo, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
NC Heart& Vascular
🇺🇸Raleigh, North Carolina, United States
Promedica Toledo Hospital
🇺🇸Toledo, Ohio, United States
Ballad Health/Holston Valley
🇺🇸Kingsport, Tennessee, United States
Virginia Commonwealth University (VCU)
🇺🇸Richmond, Virginia, United States
HCL Lyon
🇫🇷Lyon, France
Saint Joseph Marseille
🇫🇷Marseille, France
Les Franciscaines
🇫🇷Nîmes, France
Rijnstate hospital
🇳🇱Arnhem, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
EHC-Hôpital de Morges
🇨🇭Morges, Switzerland
Queen Elizabeth University Hospital, Glasgow
🇬🇧Glasgow, United Kingdom
St. Mary's Hospital
🇬🇧London, United Kingdom