GORE VBX FORWARD Clinical Study (VBX 22-06)
Research type
Research Study
Full title
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients with Complex Iliac Occlusive Disease
IRAS ID
330686
Contact name
Ashish Patel
Contact email
Sponsor organisation
W. L. Gore & Associates, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Two hundred and forty-four (244) subjects will be randomized 1:1 to treatment
with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis or bare
metal stenting.
The sites are anticipated to treat one subject every one to six
months. Accounting for timing of sites gradually phasing into the study, this
translates into an expected total accrual period of approximately 24-32 months.
No site may contribute more than 49 randomized patients to the overall
enrollment.
Once study eligibility criteria are confirmed and all guidewire(s) have
crossed the targeted lesion(s), the subject will be randomized to treatment with
the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis or bare metal
stenting. Each investigator will determine the number of devices required to
adequately treat the target lesion(s). The investigator is required to select
devices that are consistent with the assigned treatment group. Subjects will be
evaluated through hospital discharge and return for follow-up visits at 1, 6, 12,
24, 36, 48, and 60 months post-treatment. The total estimated duration of the
study is 92 months.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0265
Date of REC Opinion
7 Sep 2023
REC opinion
Further Information Favourable Opinion