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
NCT ID: NCT05811364
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
244 participants
INTERVENTIONAL
2023-10-17
2032-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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VBX Device Group
Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
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.
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
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Locations
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North Suburban Medical Center
Denver, Colorado, United States
Radiology and Imaging Specialists of Lakeland
Lakeland, Florida, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Krankenhaus der Barmherzigen Brüder
Regensburg, , Germany
Rijnstate Hospital
Arnhem, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Ehrin Armstrong, MD
Role: primary
Fakhir Elmasri, MD
Role: primary
Grace Wang, MD
Role: primary
Melissa Kirkwood, MD
Role: primary
Markus Steinbauer, MD
Role: primary
Michel Reijnen, MD
Role: primary
Andrew Holden, MD
Role: primary
References
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Kirkwood ML, Armstrong EJ, Ansari MM, Holden A, Reijnen MMPJ, Steinbauer M, Crannell Z, Novoa H, Phillips A, Schneider DB. FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial. JMIR Res Protoc. 2023 Dec 4;12:e51480. doi: 10.2196/51480.
Other Identifiers
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VBX 22-06
Identifier Type: -
Identifier Source: org_study_id
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