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

Description

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).

Conditions

Aortic Aneurysm, Abdominal

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

Randomized Controlled Clinical Trial on the Application of Heli-FX EndoAnchors in Conjunction With the Endurant II/IIs Endograft in Infrarenal Aortic Aneurysms With a Wide Infrarenal Neck (HERCULES Trial)

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

Condition
Aortic Aneurysm, Abdominal
Intervention / Treatment

-

Contacts and Locations

Washington

Washington Regional Medical Center, Washington, Arkansas, United States, 27962

Miami Beach

Mt Sinai Med Ctr, Miami Beach, Florida, United States, 33140

Royal Oak

Beaumont University Hospital, Royal Oak, Michigan, United States, 48073

Minneapolis

Alina Health, Minneapolis, Minnesota, United States, 55407

Columbia

University of Missouri, Columbia, Missouri, United States, 65211

Saint Louis

Barnes-Jewish Hospital, Saint Louis, Missouri, United States, 63110

New Brunswick

Robert Wood Johnson University Medical Center, New Brunswick, New Jersey, United States, 08901

Buffalo

Sisters of Charity hospital, Buffalo, New York, United States, 14214

Stony Brook

Stony Brook University Medical Center, Stony Brook, New York, United States, 11794

Raleigh

NC Heart& Vascular, Raleigh, North Carolina, United States, 27607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rijnstate Hospital,

MMPJ Reijnen, Prof, PRINCIPAL_INVESTIGATOR, Rijnstate, Arnhem, the Netherlands

K. Donas, Prof, PRINCIPAL_INVESTIGATOR, Asklepios Clinic Langen, Langen, Germany

Study Record Dates

2031-12