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

Part of paid clinical trials in Washington, Arkansas.

Sponsor
Rijnstate Hospital
Study ID
NCT05484115
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Aneurysm, Abdominal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system — DEVICE
    treatment of AAA's with wide proximal neck diameters with Endurant II/IIs endograft system
  • endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system — DEVICE
    treatment of AAA's with wide proximal neck diameters with the Endurant II/IIs in conjunction with the Heli-FX EndoAnchor system

Study Details

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).

Key Dates

Start date
May 26, 2023
Status verified
May 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2033

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system
  • Active Comparator: Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors

Primary Outcome Measure

Composite endpoint at on proximal seal outcomes [ Time Frame: 1 year follow-up ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Washington Regional Medical CenterWashingtonArkansas27962
R. Wood, MD (PRINCIPAL_INVESTIGATOR)
Mt Sinai Med CtrMiami BeachFlorida33140
M Ayad, MD (PRINCIPAL_INVESTIGATOR)
LoyolaMaywoodIllinois60153
P. Dr. Halandras, MD
Henry Ford HospitalDetroitMichigan48202
Dr. Mitchel Weaver
Beaumont University HospitalRoyal OakMichigan48073
O.W. Brown, MD (PRINCIPAL_INVESTIGATOR)
Alina HealthMinneapolisMinnesota55407
J. Jim, MD (PRINCIPAL_INVESTIGATOR)
University of MissouriColumbiaMissouri65211
T. Vogel, MD (PRINCIPAL_INVESTIGATOR)
Barnes-Jewish HospitalSt LouisMissouri63110
L Sanchez, MD (PRINCIPAL_INVESTIGATOR)
Robert Wood Johnson University Medical CenterNew BrunswickNew Jersey08901
Beckerman, MD (PRINCIPAL_INVESTIGATOR)
Sisters of Charity hospitalBuffaloNew York14214
P Anain, MD (PRINCIPAL_INVESTIGATOR)
Stony Brook University Medical CenterStony BrookNew York11794
A. Tassiopoulos, MD (PRINCIPAL_INVESTIGATOR)
NC Heart& VascularRaleighNorth Carolina27607
R. Mendez, MD (PRINCIPAL_INVESTIGATOR)
Promedica Toledo HospitalToledoOhio43606
B. Aplin, MD (PRINCIPAL_INVESTIGATOR)
Penn State Health Milton S. Hershey Medical CenterHersheyPennsylvania17036
Dr. Faisal Aziz, MD
[email protected]
Ballad Health/Holston ValleyKingsportTennessee37660
R. Allen, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth University (VCU)RichmondVirginia23284
Newton, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington, AR

By research site
Washington Regional Medical Center· Washington, ARMt Sinai Med Ctr· Miami Beach, FLLoyola· Maywood, ILHenry Ford Hospital· Detroit, MIBeaumont University Hospital· Royal Oak, MIAlina Health· Minneapolis, MN

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