Recruiting NCT05811364
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent.
- Who it may be relevant to
- Registry conditions: Aortoiliac Occlusive Disease, Peripheral Arterial Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Germany, Italy, Netherlands +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 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. - Device 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.
Primary outcome measures
- Primary Patency [Time frame: 1 year]
Secondary outcome measures (12)
- Technical success [Time frame: at the procedure]
- Acute procedural success [Time frame: at the procedure]
- Clinical success [Time frame: Through 1 month]
- Hemodynamic Status [Time frame: Through 5 years]
- Change in EQ-5D-5L [Time frame: Through 5 years]
- Change in WIQ [Time frame: Through 5 years]
- Primary patency [Time frame: Through 5 years]
- Freedom from binary restenosis [Time frame: Through 5 years]
- Primary assisted patency [Time frame: Through 5 years]
- Secondary patency [Time frame: Through 5 years]
- Freedom from target lesion revascularization [Time frame: Through 5 years]
- Cumulative reintervention rate [Time frame: Through 5 years]
Eligibility criteria
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.
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 26 centers
- Central Arkansas Veterans Healthcare System — Little Rock
- VA Long Beach Healthcare System — Long Beach
- Denver Health and Hospital Authority — Denver
- North Suburban Medical Center — Denver
- University of Florida - Gainesville — Gainesville
- Radiology and Imaging Specialists of Lakeland — Lakeland
- University of South Florida — Tampa
- Atlanta VA Medical Center — Decatur
- … and 18 more centers
Germany · 4 centers
- Universitats-Herzzentrum Freiburg Bad Krozingen GmbH — Bad Krozingen
- St. Franziskus Hospital — Münster
- Krankenhaus der Barmherzigen Brüder — Regensburg
- Klinikum Stuttgart — Stuttgart
Italy · 4 centers
- Ospedale Niguarda Ca'Granda — Milan
- Ospedale Santa Maria della Misericordia — Perugia
- Azienda Complesso Ospedaliero San Filippo Neri — Roma
- Ospedale San Giovanni Molinette — Turin
Australia · 3 centers
- Central Adelaide Local Health Network Incorporated — Adelaide
- Royal Perth Hospital — Nedlands
- Prince of Wales Hospital — Randwick
United Kingdom · 3 centers
- East Kent Hospitals University NHS Foundation Trust — Canterbury
- Guy's and St Thomas', NHS Foundation Trust — London
- University Hospital Southampton NHS Foundation Trust — Southampton
Netherlands · 2 centers
- Rijnstate Hospital — Arnhem
- Stichting Elisabeth-TweeSteden Ziekenhuis — Tilburg
New Zealand · 1 center
- Auckland City Hospital — Auckland
Publications
- 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 Pr PMID 38048145
Identifiers
NCT: NCT05811364 · VBX 22-06