Actively Recruiting
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
Led by W.L.Gore & Associates · Updated on 2026-05-13
244
Participants Needed
43
Research Sites
432 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of informed consent
- Signed informed consent form
- Ability to follow study protocol and attend follow-up visits
- Symptoms including claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)
- De novo or restenotic lesion(s) in the common and/or external iliac artery(ies)
- Unilateral or bilateral single or multiple lesions with more than 50% stenosis or chronic total occlusion, each 4 to 11 cm long
- Target vessel diameter estimated to be approximately between 5 mm and 13 mm
- Common femoral artery and at least one femoral artery (deep or superficial) with less than 50% stenosis
- At least one infrapopliteal run-off vessel with less than 50% stenosis
You will not qualify if you...
- Life expectancy less than 1 year
- Pregnant at time of informed consent
- Known allergy to stent or stent graft components such as nitinol, stainless steel, or heparin
- Severe chronic renal insufficiency with serum creatinine level above 2.5 mg/dL and not on hemodialysis
- Evidence of systemic infection
- Known intolerance to antithrombotic medications preventing study compliance
- Vascular catheterization of lower extremities within 30 days before randomization (except diagnostic angiograms for study)
- Previous stenting in the iliac arteries
- Previous surgical bypass in the target limb
- Participation in another investigational clinical study without sponsor approval
- Lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or ablative device to deliver stent
- Abdominal aortic artery lesion or aneurysm
- Lesion requiring stent placement within 2 cm of the inguinal ligament
- Isolated common iliac artery stenosis treatable with a single device
- Outflow disease requiring additional interventions like common femoral endarterectomy or femoral/tibial revascularization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 43 locations
1
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
Withdrawn
2
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
Actively Recruiting
3
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Actively Recruiting
4
North Suburban Medical Center
Denver, Colorado, United States, 80229
Withdrawn
5
University of Florida - Gainesville
Gainesville, Florida, United States, 32608
Actively Recruiting
6
Radiology and Imaging Specialists of Lakeland
Lakeland, Florida, United States, 33801
Actively Recruiting
7
University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
8
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Actively Recruiting
9
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
10
Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
Corewell Health System
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
12
The Curators of the University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
13
Research Foundation SUNY Buffalo
Amherst, New York, United States, 14228
Withdrawn
14
Trinity Medical Center
Buffalo, New York, United States, 14214
Actively Recruiting
15
VA Western New York Healthcare System
Buffalo, New York, United States, 14215
Actively Recruiting
16
New York University School of Medicine
New York, New York, United States, 10016
Actively Recruiting
17
Mt. Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
18
Atrium Health
Charlotte, North Carolina, United States, 28210
Actively Recruiting
19
University Hospitals - Cleveland Medical Center
Ashland, Ohio, United States, 44805
Actively Recruiting
20
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
21
Portland Health Care System VA
Portland, Oregon, United States, 97239
Actively Recruiting
22
Providence Heart & Vascular Institute
Wilsonville, Oregon, United States, 97070
Actively Recruiting
23
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
24
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660
Actively Recruiting
25
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
26
Sentara Medical Group
Norfolk, Virginia, United States, 23507
Actively Recruiting
27
Central Adelaide Local Health Network Incorporated
Adelaide, Australia
Actively Recruiting
28
Royal Perth Hospital
Nedlands, Australia
Actively Recruiting
29
Prince of Wales Hospital
Randwick, Australia
Actively Recruiting
30
Universitats-Herzzentrum Freiburg Bad Krozingen GmbH
Bad Krozingen, Germany
Actively Recruiting
31
St. Franziskus Hospital
Münster, Germany
Actively Recruiting
32
Krankenhaus der Barmherzigen Brüder
Regensburg, Germany
Actively Recruiting
33
Klinikum Stuttgart
Stuttgart, Germany
Actively Recruiting
34
Ospedale Niguarda Ca'Granda
Milan, MI, Italy
Actively Recruiting
35
Ospedale Santa Maria della Misericordia
Perugia, Italy
Actively Recruiting
36
Azienda Complesso Ospedaliero San Filippo Neri
Roma, Italy
Actively Recruiting
37
Ospedale San Giovanni Molinette
Turin, Italy
Actively Recruiting
38
Rijnstate Hospital
Arnhem, Netherlands
Actively Recruiting
39
Stichting Elisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
Actively Recruiting
40
Auckland City Hospital
Auckland, New Zealand
Actively Recruiting
41
East Kent Hospitals University NHS Foundation Trust
Canterbury, United Kingdom
Actively Recruiting
42
Guy's and St Thomas', NHS Foundation Trust
London, United Kingdom
Actively Recruiting
43
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Actively Recruiting
Research Team
A
Alexander Ambrocik
CONTACT
E
Enoque Costa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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