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Recruiting Not applicable

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

NCT05484115 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-05-26
Last updated
2026-05-11

Condition(s) studied

Aortic Aneurysm, Abdominal

Investigational drug(s) / intervention(s)

endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft systemendosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system

endovascular 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

endosuture 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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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).

Trial sites (36)

FacilityCityRegionStatus
Washington Regional Medical Center Washington Arkansas Recruiting
Mt Sinai Med Ctr Miami Beach Florida Recruiting
Loyola Maywood Illinois Recruiting
Henry Ford Hospital Detroit Michigan Not Yet Recruiting
Beaumont University Hospital Royal Oak Michigan Recruiting
Alina Health Minneapolis Minnesota Recruiting
University of Missouri Columbia Missouri Recruiting
Barnes-Jewish Hospital St Louis Missouri Recruiting
Robert Wood Johnson University Medical Center New Brunswick New Jersey Recruiting
Sisters of Charity hospital Buffalo New York Recruiting
Stony Brook University Medical Center Stony Brook New York Recruiting
NC Heart& Vascular Raleigh North Carolina Recruiting
Promedica Toledo Hospital Toledo Ohio Recruiting
Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania Recruiting
Ballad Health/Holston Valley Kingsport Tennessee Recruiting
Virginia Commonwealth University (VCU) Richmond Virginia Recruiting
HCL Lyon Lyon France Recruiting
Saint Joseph Marseille Marseille France Recruiting
Les Franciscaines Nîmes France Recruiting
Asklepios Klinik Langen Langen Hesse Recruiting
Universitatsklinikum Frankfurt Frankfurt Germany Not Yet Recruiting
University Hospital Leipzig Leipzig Germany Recruiting
IRCCS Ospedale Policlinico San Martino Genova Metropolitan City of Genoa Recruiting
Osp. S.Orsola Malpighi - Bologna Bologna Italy Recruiting
Noordwest ziekenhuis Alkmaar North Holland Not Yet Recruiting
Spaarne Gasthuis Haarlem North Holland Not Yet Recruiting
Rijnstate hospital Arnhem Netherlands Recruiting
Catharina Ziekenhuis Eindhoven Netherlands Recruiting
Hospital Clinic de Barcelona Barcelona Spain Recruiting
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain Recruiting
Hospital Universitario Miguel Servet Zaragoza Spain Not Yet Recruiting
EHC-Hôpital de Morges Morges Switzerland Recruiting
Queen Elizabeth University Hospital, Glasgow Glasgow United Kingdom Recruiting
Leeds General Infirmary Leeds United Kingdom Recruiting
St. George's Hospital London United Kingdom Recruiting
St. Mary's Hospital London United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05484115 on ClinicalTrials.gov ↗ ← All trials in Italy