Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05811364




Registration number
NCT05811364
Ethics application status
Date submitted
14/03/2023
Date registered
13/04/2023
Date last updated
9/11/2023

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
VBX 22-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortoiliac Occlusive Disease 0 0
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Treatment: Devices - Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent

Active Comparator: VBX Device Group - Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

Active Comparator: BMS Control Group - Subjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease


Treatment: Devices: Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.

Treatment: Devices: Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
Treatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Patency
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Technical success
Timepoint [1] 0 0
at the procedure
Secondary outcome [2] 0 0
Acute procedural success
Timepoint [2] 0 0
at the procedure
Secondary outcome [3] 0 0
Clinical success
Timepoint [3] 0 0
Through 1 month
Secondary outcome [4] 0 0
Hemodynamic Status
Timepoint [4] 0 0
Through 5 years
Secondary outcome [5] 0 0
Change in EQ-5D-5L
Timepoint [5] 0 0
Through 5 years
Secondary outcome [6] 0 0
Change in WIQ
Timepoint [6] 0 0
Through 5 years
Secondary outcome [7] 0 0
Primary patency
Timepoint [7] 0 0
Through 5 years
Secondary outcome [8] 0 0
Freedom from binary restenosis
Timepoint [8] 0 0
Through 5 years
Secondary outcome [9] 0 0
Primary assisted patency
Timepoint [9] 0 0
Through 5 years
Secondary outcome [10] 0 0
Secondary patency
Timepoint [10] 0 0
Through 5 years
Secondary outcome [11] 0 0
Freedom from target lesion revascularization
Timepoint [11] 0 0
Through 5 years
Secondary outcome [12] 0 0
Cumulative reintervention rate
Timepoint [12] 0 0
Through 5 years
Secondary outcome [13] 0 0
Freedom from clinically driven target lesion revascularization
Timepoint [13] 0 0
Through 5 years
Secondary outcome [14] 0 0
Amputation-free survival
Timepoint [14] 0 0
Through 5 years
Secondary outcome [15] 0 0
Survival
Timepoint [15] 0 0
Through 5 years
Secondary outcome [16] 0 0
Change in Rutherford Category
Timepoint [16] 0 0
Through 5 years

Eligibility
Key inclusion criteria
- Age = 18 years at time of informed consent signature

- Informed Consent Form (ICF) is signed by the subject

- Subject can comply with protocol requirements, including follow-up

- Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford
Category 2-5)

- Patient has de novo or restenotic lesion(s) found in the common and/or external iliac
artery(ies)

- Patient has: Unilateral or bilateral single or multiple lesions (>50% stenosis or
chronic total occlusion) each between 4 and 11 cm in length

- Patient has a target vessel diameter visually estimated to be approximately between 5
mm and 13 mm

- Patient has a sufficient (<50% stenotic) common femoral artery and at least one
sufficient (<50% stenotic) femoral artery (deep or superficial).

- Patient has at least one sufficient (<50% stenotic) infrapopliteal run-off vessel.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Life expectancy <1 year

- Patient is pregnant at time of informed consent.

- Patient has a known allergy to stent or stent graft components (including nitinol,
stainless steel, or heparin).

- Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and
not undergoing hemodialysis.

- Patient has evidence of a systemic infection.

- Patient has a known intolerance to antithrombotic medications that prevent compliance
with study or control device Instructions for Use.

- Patient has had vascular catheterization of the lower extremities within 30 days of
randomization (excluding diagnostic angiograms for the study procedure).

- Patient has previous stenting in the iliac arteries.

- Patient has previous surgical bypass in the target limb.

- Patient is currently participating in another investigative clinical study unless
received written approval by the sponsor.

- Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy,
lithotripsy, or any ablative device to facilitate stent delivery.

- Patient has an abdominal aortic artery lesion or aneurysm.

- Patient has a lesion that requires stent placement within 2 cm of the inguinal
ligament.

- Patient has isolated common iliac artery stenosis that can be treated with a single
device (i.e., common iliac artery stenosis that does not require kissing stents or
extend into the external iliac artery).

- Patient has outflow disease that requires concomitant interventions (i.e. common
femoral endarterectomy or femoral / tibial revascularization).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2031
Actual
Sample size
Target
244
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Germany
State/province [5] 0 0
Regensburg
Country [6] 0 0
Netherlands
State/province [6] 0 0
Arnhem
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
W.L.Gore & Associates
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this prospective, multicenter, randomized, controlled clinical trial is to
demonstrate the superiority of the VBX Device for primary patency when compared to bare metal
stenting in complex iliac occlusive disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05811364
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Makensley Lordeus
Address 0 0
Country 0 0
Phone 0 0
623-234-5989
Fax 0 0
Email 0 0
mlordeus@wlgore.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05811364