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

Launched by W.L.GORE & ASSOCIATES · Mar 30, 2023

Keywords

ClinConnect Summary

The GORE VBX FORWARD Clinical Study is investigating a new device called the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to see if it works better than standard bare metal stents for patients with complex iliac occlusive disease, which affects blood flow in the pelvis and legs. This study aims to determine if the VBX device can keep blood vessels open longer, which can help relieve symptoms like leg pain and improve overall health.

To participate in this trial, patients must be at least 18 years old and have specific leg conditions causing pain or other issues. They should have blockages in their iliac arteries that are significant enough to require treatment. Patients will need to agree to follow-up visits and be able to comply with study requirements. Those with certain health issues, like severe kidney problems or infections, are not eligible. If selected, participants can expect to receive either the new VBX device or the standard stenting treatment and will be monitored closely throughout the study to evaluate their progress.

Gender

ALL

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).