RECRUITING

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

Talk to us

Conditions

Aortic Aneurysm, AbdominalAAAEndovascular treatmentWide proximal neckEndoAnchorsInfrarenalEVAR (Endovascular aneurysm repair)ESAR (Endosuture aneurysm repair)Endurant II/IIs stent graft systemHeli-FX EndoAnchor system

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2023-05-26
Study Completion:2031-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05484115

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Provided written informed consent
  3. * Clinical necessity for treatment of the AAA, according to the current guidelines in the geographies participating
  4. * Elective repair
  5. * Eligible anatomy for treatment with the Endurant II/IIs stent graft system and Heli-FX EndoAnchor system according to the IFU of both devices
  6. * Infrarenal neck diameter ≥ 28 mm and ≤32 mm
  7. * Proximal neck length ≥10mm
  1. * Anatomy outside the IFU of the ndurant II/IIs stent graft system and Heli-FX EndoAnchor system
  2. * Planned use of AUI main body device
  3. * Patient is participating in another clinical study, potentially conflicting with the outcomes of the current study.
  4. * Patient with eGFR \< 30 ml/min/1.73m2 before the intervention
  5. * Patient's life expectancy \<2 years as judged by the investigator
  6. * Patient has a psychiatric or other condition that may interfere with the study
  7. * Patient has a known allergy to any device component
  8. * Patients with a systemic infection who may be at increased risk of endovascular graft infection.
  9. * Patient has a coagulopathy or uncontrolled bleeding disorder
  10. * Patient has a ruptured, leaking, or mycotic aneurysm
  11. * Patient is not eligible for standard EVAR
  12. * Patient had a Cerebro Vascular Accident (CVA) or a myocardial infarction (MI) within the prior three months
  13. * Patient is pregnant (Female patients of childbearing potential only)
  14. * Patient has active COVID-19 infection or has been diagnosed with long COVID-19 requiring hospitalization within the 6 months prior to procedure.
  15. * Patient has previously been treated with stent grafts in the aorto-iliac arteries

Contacts and Locations

Study Contact

Suzanne Holewijn, PhD
CONTACT
0031880057282
vascularsurgery@rijnstate.nl
Daphne van der Veen, MSc
CONTACT
0031880057282
vascularsurgery@rijnstate.nl

Principal Investigator

MMPJ Reijnen, Prof
PRINCIPAL_INVESTIGATOR
Rijnstate, Arnhem, the Netherlands
K. Donas, Prof
PRINCIPAL_INVESTIGATOR
Asklepios Clinic Langen, Langen, Germany

Study Locations (Sites)

Washington Regional Medical Center
Washington, Arkansas, 27962
United States
Mt Sinai Med Ctr
Miami Beach, Florida, 33140
United States
Beaumont University Hospital
Royal Oak, Michigan, 48073
United States
Alina Health
Minneapolis, Minnesota, 55407
United States
University of Missouri
Columbia, Missouri, 65211
United States
Barnes-Jewish Hospital
Saint Louis, Missouri, 63110
United States
Robert Wood Johnson University Medical Center
New Brunswick, New Jersey, 08901
United States
Sisters of Charity hospital
Buffalo, New York, 14214
United States
Stony Brook University Medical Center
Stony Brook, New York, 11794
United States
NC Heart& Vascular
Raleigh, North Carolina, 27607
United States
Promedica Toledo Hospital
Toledo, Ohio, 43606
United States
Ballad Health/Holston Valley
Kingsport, Tennessee, 37660
United States
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23284
United States

Collaborators and Investigators

Sponsor: Rijnstate Hospital

  • MMPJ Reijnen, Prof, PRINCIPAL_INVESTIGATOR, Rijnstate, Arnhem, the Netherlands
  • K. Donas, Prof, PRINCIPAL_INVESTIGATOR, Asklepios Clinic Langen, Langen, Germany

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-26
Study Completion Date2031-12

Study Record Updates

Study Start Date2023-05-26
Study Completion Date2031-12

Terms related to this study

Keywords Provided by Researchers

  • AAA
  • Endovascular treatment
  • Wide proximal neck
  • EndoAnchors
  • Infrarenal
  • EVAR (Endovascular aneurysm repair)
  • ESAR (Endosuture aneurysm repair)
  • Endurant II/IIs stent graft system
  • Heli-FX EndoAnchor system

Additional Relevant MeSH Terms

  • Aortic Aneurysm, Abdominal