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New treatment option for Aortoiliac Occlusive Disease
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
ClinicalTrials.gov ID: NCT05811364
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)
You likely can't join 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.
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Long Beach, California, United States
- Denver, Colorado, United States
- Gainesville, Florida, United States
- Lakeland, Florida, United States
- Tampa, Florida, United States
- Decatur, Georgia, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Columbia, Missouri, United States
- Amherst, New York, United States
- Buffalo, New York, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Ashland, Ohio, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Wilsonville, Oregon, United States
- Philadelphia, Pennsylvania, United States
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Long Beach, California, United States; Denver, Colorado, United States; Gainesville, Florida, United States; Lakeland, Florida, United States; Tampa, Florida, United States and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.