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
1 other identifier
interventional
244
7 countries
43
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2023
CompletedFirst Posted
Study publicly available on registry
April 13, 2023
CompletedStudy Start
First participant enrolled
October 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2032
May 13, 2026
May 1, 2026
4.5 years
March 14, 2023
May 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Patency
Blood flow through the target lesion (no evidence of binary restenosis \>50% or occlusion) without a Target Lesion Revascularization (TLR).
1 year
Secondary Outcomes (16)
Technical success
at the procedure
Acute procedural success
at the procedure
Clinical success
Through 1 month
Hemodynamic Status
Through 5 years
Change in EQ-5D-5L
Through 5 years
- +11 more secondary outcomes
Study Arms (2)
VBX Device Group
ACTIVE COMPARATORSubject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
BMS Control Group
ACTIVE COMPARATORSubjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease
Interventions
Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
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
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205, United States
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
North Suburban Medical Center
Denver, Colorado, 80229, United States
University of Florida - Gainesville
Gainesville, Florida, 32608, United States
Radiology and Imaging Specialists of Lakeland
Lakeland, Florida, 33801, United States
University of South Florida
Tampa, Florida, 33620, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts, 02215, United States
Corewell Health System
Grand Rapids, Michigan, 49503, United States
The Curators of the University of Missouri
Columbia, Missouri, 65212, United States
Research Foundation SUNY Buffalo
Amherst, New York, 14228, United States
Trinity Medical Center
Buffalo, New York, 14214, United States
VA Western New York Healthcare System
Buffalo, New York, 14215, United States
New York University School of Medicine
New York, New York, 10016, United States
Mt. Sinai Medical Center
New York, New York, 10029, United States
Atrium Health
Charlotte, North Carolina, 28210, United States
University Hospitals - Cleveland Medical Center
Ashland, Ohio, 44805, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Portland Health Care System VA
Portland, Oregon, 97239, United States
Providence Heart & Vascular Institute
Wilsonville, Oregon, 97070, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Sentara Medical Group
Norfolk, Virginia, 23507, United States
Central Adelaide Local Health Network Incorporated
Adelaide, Australia
Royal Perth Hospital
Nedlands, Australia
Prince of Wales Hospital
Randwick, Australia
Universitats-Herzzentrum Freiburg Bad Krozingen GmbH
Bad Krozingen, Germany
St. Franziskus Hospital
Münster, Germany
Krankenhaus der Barmherzigen Brüder
Regensburg, Germany
Klinikum Stuttgart
Stuttgart, Germany
Ospedale Niguarda Ca'Granda
Milan, MI, Italy
Ospedale Santa Maria della Misericordia
Perugia, Italy
Azienda Complesso Ospedaliero San Filippo Neri
Roma, Italy
Ospedale San Giovanni Molinette
Turin, Italy
Rijnstate Hospital
Arnhem, Netherlands
Stichting Elisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
Auckland City Hospital
Auckland, New Zealand
East Kent Hospitals University NHS Foundation Trust
Canterbury, United Kingdom
Guy's and St Thomas', NHS Foundation Trust
London, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Related Publications (1)
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.
PMID: 38048145DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Every effort will be made to blind subjects to the treatment device up to the 1 year follow up visit. The independent Core Lab and Clinical Events Committee (CEC) members will also be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2023
First Posted
April 13, 2023
Study Start
October 17, 2023
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
January 31, 2032
Last Updated
May 13, 2026
Record last verified: 2026-05