Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
Other trials for the same condition
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