Evaluation of the GORE® Ascending Stent Graft

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
W.L.Gore & Associates
Study ID
NCT05800743
Status
Enrolling By Invitation

Conditions

  • Aorta; Lesion
  • Aortic Aneurysm, Thoracic
  • Aortic Dissection
  • Pseudoaneurysm

Eligibility Criteria

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

Interventions

  • GORE® Ascending Stent Graft (ASG device) — DEVICE
    Endovascular aortic repair of the ascending aorta
  • GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device) — DEVICE
    Endovascular aortic repair of the ascending aorta/aortic arch
  • Surgery — PROCEDURE
    Open surgical repair of the ascending aorta and/or the aortic arch

Study Details

The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.

Key Dates

Start date
Nov 28, 2023
Status verified
May 2026
Primary completion
Oct 31, 2029
Completion
Jan 31, 2034

Study Design

Enrollment
370 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ASG device only in Ascending Aorta
    Ascending Aortic Isolated Lesions, Pseudoaneurysms and Penetrating Aortic Ulcers in subjects at high-risk for surgical repair, treated with endovascular repair using the ASG device alone.
  • Experimental: ASG + TBE
    Ascending Aorta/Aortic Arch Isolated Lesions and Chronic De Novo Dissections in subjects at high-risk for surgical repair, treated with endovascular repair using the ASG and TBE devices.
  • Other: Surgical Follow-up Cohort
    Open surgical repair of ascending aorta in subjects at high-risk for surgical repair

Primary Outcome Measure

Primary effectiveness endpoint as measured by device technical success and absence of reintervention. [ Time Frame: 30 Days ]

Locations (41)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
MemorialCare Heart and Vascular Institute - Long Beach Medical CenterLong BeachCalifornia90806-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Keck Medical Center University of Southern California, HCC IILos AngelesCalifornia90033-
Stanford HospitalStanfordCalifornia94305-
University of Colorado Hospital AuthorityAuroraColorado80045-
Hartford HospitalHartfordConnecticut06102-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
University of Florida - GainesvilleGainesvilleFlorida32610-
University of South FloridaTampaFlorida33606-
Emory University HospitalAtlantaGeorgia30322-
Northwestern University -Bluhm Cardiovascular Institute, Clinical Trials UnitChicagoIllinois60611-
Indiana University School of MedicineIndianapolisIndiana46202-
University of Maryland Medical CenterBaltimoreMaryland21201-
Massachusetts General HospitalBostonMassachusetts02114-
University of Michigan Frankel Cardiovascular CenterAnn ArborMichigan48109-
Corewell HealthGrand RapidsMichigan49503-
Mayo Clinic - RochesterRochesterMinnesota55905-
Washington University School of Medicine - St. LouisSt LouisMissouri63110-
Hackensack UMCHackensackNew Jersey07601-
Westchester Medical CenterValhallaNew York10595-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Atrium HealthCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland Clinic FoundationClevelandOhio44195-
OhioHealth Research and Innovation InstituteColumbusOhio43214-
Oregon Health and Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19105-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Lankenau Institute for Medical ResearchWynnewoodPennsylvania19096-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Cardiothoracic and Vascular SurgeonsAustinTexas78756-
Methodist DeBakey Heart & Vascular CenterHoustonTexas77030-
The Heart Hospital at Baylor PlanoPlanoTexas75093-
Intermountain Heart InstituteMurrayUtah84107-
Inova Fairfax Medical CampusFalls ChurchVirginia22042-
Sentara Mid Atlantic Cardiothoracic SurgeonsNorfolkVirginia23507-
University of Washington Medical CenterSeattleWashington98195-
West Virginia University MedicineMorgantownWest Virginia26506-
University of Wisconsin Hospital & ClinicsMadisonWisconsin53792-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALMemorialCare Heart and Vascular Institute - Long Beach Medical Center· Long Beach, CACedars Sinai Medical Center· Los Angeles, CAKeck Medical Center University of Southern California, HCC II· Los Angeles, CAStanford Hospital· Stanford, CAUniversity of Colorado Hospital Authority· Aurora, CO

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