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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD). 2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure. 3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date. 4. Age ≥18 years at the time of CERAB procedure. 5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -

Exclusion Criteria

  1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure. 2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery). 3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints. -

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
GORE VIABAHN® VBX Balloon Expandable Endoprosthesis Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
  • Device: GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
    Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.

Recruiting Locations

University of California
Fresno, California 93721
Contact:
Jessica Gallegos

University of South Florida
Tampa, Florida 33606
Contact:
Charles Briggs, M.D.
813-505-4787
cbriggs@usf.edu

Mayo Clinic Rochester
Rochester, Minnesota 55905
Contact:
Samantha Knight

Cooper University Hospital
Camden, New Jersey 08103
Contact:
Jonelle O'Shea

Rutgers
New Brunswick, New Jersey 08901
Contact:
Marie Macor

Research Foundation SUNY Buffalo
Buffalo, New York 14203
Contact:
Dawn Holler

Mount Sinai Medical Center
New York, New York 10029
Contact:
Bridget Coyle

Research Foundation at SUNY Syracuse
Syracuse, New York 13210
Contact:
Maria Walker

Atrium Health Sanger Heart & Vascular Institute
Charlotte, North Carolina 28203
Contact:
Houston Chapman

Ohio State University Medical Center
Columbus, Ohio 43210
Contact:
Subhashish Das

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Rebecca Mack

University Of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Carolina Reyes

Sanford Clinical Vascular Associates
Sioux Falls, South Dakota 57105
Contact:
Karla Reily

Wellmont Holston Valley Medical Center
Kingsport, Tennessee 37760
Contact:
Ashley Bowen

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Lori Michalowski

The University of Texas Austin
Austin, Texas 78712
Contact:
Andrea Stapper

University of Virginia
Charlottesville, Virginia 22908
Contact:
Robin Kelly

Carilion Clinic
Roanoke, Virginia 24016
Contact:
Yili Zhong

Marshfield Hospital
Marshfield, Wisconsin 54449
Contact:
Angela Varsho

Marshfield Medical Center - Marshfield
Marshfield, Wisconsin 54449
Contact:
Angela Varsho

More Details

Status
Recruiting
Sponsor
W.L.Gore & Associates

Study Contact

Jennifer Camoriano, BS
14805365820
jcamoria@wlgore.com

Detailed Description

A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.