AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - anyAllRijnstate Hospital
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 (โ‰ฅ 28mm and โ‰ค 32mm).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 28 mm and โ‰ค32 mm * Proximal neck length โ‰ฅ10mm 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
๐Ÿ’Š

What it tests

  • endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
  • endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system
๐Ÿ“

Where

36 sites
Washington Regional Medical Center
Washington, United States
Mt Sinai Med Ctr
Miami Beach, United States
Loyola
Maywood, United States
Henry Ford Hospital
Detroit, United States
Beaumont University Hospital
Royal Oak, United States
Alina Health
Minneapolis, United States
University of Missouri
Columbia, United States
Barnes-Jewish Hospital
St Louis, United States

โ€ฆand 28 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy