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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
Trial website
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05811364