Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Part of paid clinical trials in Loma Linda, California.

Sponsor
Medtronic Cardiovascular
Study ID
NCT05378347
Status
Recruiting
Apply to this trial

Conditions

  • Abdominal Aortic Aneurysm
  • Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
  • Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)

Eligibility Criteria

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

Interventions

  • Medtronic Endurant II or Endurant IIs Stent Graft System — DEVICE
    EVAR treatment with Medtronic Endurant II/IIs Stent Graft System
  • Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis — DEVICE
    EVAR treatment with Excluder / Excluder Conformable Stent Graft System

Study Details

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.

Key Dates

Start date
Jan 5, 2023
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2031

Study Design

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

Arms

  • Experimental: Medtronic Endurant II/IIs
    Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.
  • Experimental: Gore Excluder / Excluder Conformable
    Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.

Primary Outcome Measure

Sac Regression [ Time Frame: 12 months ]

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
Loma Linda University Medical CenterLoma LindaCalifornia92354
Ahmed Abou-Zamzam, MD (PRINCIPAL_INVESTIGATOR)
Hoag HospitalNewport BeachCalifornia92663
Allen Murga
Allen Murga (PRINCIPAL_INVESTIGATOR)
University of California Irvine Medical CenterOrangeCalifornia92868
Anthony Chau, MD (PRINCIPAL_INVESTIGATOR)
University of California Davis Medical CenterSacramentoCalifornia95817-
University of California San Francisco UCSF Medical CenterSan FranciscoCalifornia94143
Jade Hiramoto, MD (PRINCIPAL_INVESTIGATOR)
Denver Health Medical CenterDenverColorado80204
Lisa Bennett, MD, MS (PRINCIPAL_INVESTIGATOR)
Yale Center for Clinical InvestigationNew HavenConnecticut06519
David Kuwayama, MD (PRINCIPAL_INVESTIGATOR)
Medstar Washington Hospital CenterWashington D.C.District of Columbia20010
Steven Abramowitz, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
Young Erben, MD (PRINCIPAL_INVESTIGATOR)
Sarasota Memorial HospitalSarasotaFlorida34239
Jason Wagner, MD (PRINCIPAL_INVESTIGATOR)
Northside Hospital ForsythAtlantaGeorgia30342
Siddharth Patel
Northshore University Health SystemSkokieIllinois60076
Cheong Jun Lee, MD (PRINCIPAL_INVESTIGATOR)
Ascension Via Christi Saint FrancisWichitaKansas67214
Chad Ammar, MD (PRINCIPAL_INVESTIGATOR)
University of KentuckyLexingtonKentucky40536
Sam C Tyagi, MD (PRINCIPAL_INVESTIGATOR)
Maine Medical CenterPortlandMaine04102
Kristina Giles, MD (PRINCIPAL_INVESTIGATOR)
VA Maryland Health Care SystemBaltimoreMaryland21201
Areck Ucuzian, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Marc Schermerhorn, MD (PRINCIPAL_INVESTIGATOR)
Baystate Medical CenterSpringfieldMassachusetts01199
Matthew Kronick, MD (PRINCIPAL_INVESTIGATOR)
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Jeffrey Jim
Mayo Clinic RochesterRochesterMinnesota55905
Randall DeMartino, MD (PRINCIPAL_INVESTIGATOR)
Albany Medical CollegeAlbanyNew York12208-
Northwell Health Lenox Hill HospitalNew YorkNew York10075
Alfio Carroccio, MD (PRINCIPAL_INVESTIGATOR)
Westchester Medical CenterValhallaNew York10595
Igor Laskowski, MD (PRINCIPAL_INVESTIGATOR)
Novant Health Forsyth Medical CenterWinston-SalemNorth Carolina27103
Phillip Moore, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals, Cleveland Medical CenterClevelandOhio44106
Jae Cho, MD (PRINCIPAL_INVESTIGATOR)
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Grace Wang, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15232
Nathan Liang, MD (PRINCIPAL_INVESTIGATOR)
Prisma HealthGreenvilleSouth Carolina29615-
Cardiovascular Surgery ClinicMemphisTennessee38120-
University of Texas Health Science Center at HoustonHoustonTexas77030
Rana Afifi, MD (PRINCIPAL_INVESTIGATOR)
The Heart Hospital Baylor PlanoPlanoTexas75093
Elyza Guerrero
Dennis Gable, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Health SystemCharlottesvilleVirginia22908
Margaret C Tracci, MD, JD (PRINCIPAL_INVESTIGATOR)

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