Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease

Part of paid clinical trials in Fresno, California.

Sponsor
W.L.Gore & Associates
Study ID
NCT06872905
Status
Recruiting
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Conditions

  • Aortoiliac Occlusive Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX) — DEVICE
    Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.

Study Details

The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).

Key Dates

Start date
May 30, 2025
Status verified
Mar 2026
Primary completion
Aug 16, 2027
Completion
Aug 16, 2027

Study Design

Enrollment
158 participants (estimated)

Arms

  • Arm: GORE VIABAHN® VBX Balloon Expandable Endoprosthesis
    Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure.

Primary Outcome Measure

Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing) [ Time Frame: 1-Year ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
University of CaliforniaFresnoCalifornia93721
Jessica Gallegos
Leigh Ann O'Banion, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33606
Charles Briggs, M.D.
[email protected]
813-505-4787
Beth Montera
[email protected]
1-813-844-7948
Mayo Clinic RochesterRochesterMinnesota55905
Samantha Knight
Fahad Shuja, MBBS (PRINCIPAL_INVESTIGATOR)
Cooper University HospitalCamdenNew Jersey08103
Jonelle O'Shea
Laurel Hastings, MD (PRINCIPAL_INVESTIGATOR)
RutgersNew BrunswickNew Jersey08901
Marie Macor
William Beckerman, MD (PRINCIPAL_INVESTIGATOR)
Research Foundation SUNY BuffaloBuffaloNew York14203
Dawn Holler
Linda Harris, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai Medical CenterNew YorkNew York10029
Bridget Coyle
Ajit Rao, MD (PRINCIPAL_INVESTIGATOR)
Research Foundation at SUNY SyracuseSyracuseNew York13210
Maria Walker
Palma Shaw, MD (PRINCIPAL_INVESTIGATOR)
Fawaz Araim, MD (SUB_INVESTIGATOR)
Atrium Health Sanger Heart & Vascular InstituteCharlotteNorth Carolina28203
Houston Chapman
Hector Crespo-Soto, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Medical CenterColumbusOhio43210
Subhashish Das
Kyongjune Lee, MD (PRINCIPAL_INVESTIGATOR)
Geisinger Medical CenterDanvillePennsylvania17822
Rebecca Mack
Evan Ryer, MD (PRINCIPAL_INVESTIGATOR)
University Of PennsylvaniaPhiladelphiaPennsylvania19104
Carolina Reyes
Grace WANG, MD (PRINCIPAL_INVESTIGATOR)
Sanford Clinical Vascular AssociatesSioux FallsSouth Dakota57105
Karla Reily
Anand Dayama, MD (PRINCIPAL_INVESTIGATOR)
Wellmont Holston Valley Medical CenterKingsportTennessee37760
Ashley Bowen
Ryan Cronin, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Lori Michalowski
Daniiel Clair, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas AustinAustinTexas78712
Andrea Stapper
Meryl Logan, MD (PRINCIPAL_INVESTIGATOR)
Carilion ClinicRoanokeVirginia24016
Yili Zhong
Esmaeel Dadashzadeh, MD (PRINCIPAL_INVESTIGATOR)
Marshfield HospitalMarshfieldWisconsin54449
Angela Varsho
Shameem Kunhammed, MD (PRINCIPAL_INVESTIGATOR)
Marshfield Medical Center - MarshfieldMarshfieldWisconsin54449
Angela Varsho
Shameem Kunhammed, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fresno, CA

By research site
University of California· Fresno, CAUniversity of South Florida· Tampa, FLMayo Clinic Rochester· Rochester, MNCooper University Hospital· Camden, NJRutgers· New Brunswick, NJResearch Foundation SUNY Buffalo· Buffalo, NY

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