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

To be considered for this study, you need to be at least 18 years old and understand what the study involves and agree to take part. You should be experiencing leg pain when walking, at rest, or have minor skin problems due to poor blood flow. Doctors will look for blockages or narrowings in the main arteries leading to your legs (called iliac arteries) that are between 4 and 11 cm long and seem to be at least 5mm wide, but no wider than 13mm. Your other leg arteries should also be in good enough condition.

There are also reasons why you might not be able to join. For example, if you are pregnant, have a severe kidney problem, a current infection, or an allergy to materials used in the stents. You can't have had previous stenting in these specific leg arteries or recent surgery like a bypass on the affected leg. If you've recently had other procedures on your legs or are already in another medical study, you might also not be suitable.

If you decide to take part, you'll first have a procedure where either the GORE VIABAHN VBX stent or a standard bare metal stent will be placed in your narrowed artery – you won't get to choose which one. After the procedure, you'll have several follow-up appointments with the study team. These appointments usually involve check-ups, questionnaires, and perhaps some scans to see how your stent is working and how you're feeling. You'll need to follow specific instructions regarding any medicines you might need to take, especially those to prevent blood clots. The total length of your participation will involve these appointments over an extended period to monitor the stent's performance long-term.