Comparing the GORE VIABAHN VBX Balloon Expandable Endoprosthesis to Bare Metal Stents for Treating Complex Iliac Artery Blockages

What this Trial Is About

Researchers are studying a device called the GORE VIABAHN VBX Balloon Expandable Endoprosthesis to treat people with complex iliac occlusive disease, a condition affecting blood flow in the iliac arteries. This clinical trial is designed to compare this device to bare metal stenting, aiming to see which approach better keeps the arteries open over time. The study is prospective, multicenter, randomized, and controlled with a double masking design. Participants will be randomly assigned to one of two groups one receiving the GORE VIABAHN VBX device and the other receiving a commercially available bare metal stent approved for this condition. Treatments focus on the common andor external iliac arteries with lesions between 4 and 11 cm and vessel diameters between 5 mm and 13 mm. Both groups will receive stenting procedures using these devices. During the trial, participants will undergo evaluations to measure artery openness primary patency at one year and up to five years. Additional measures include technical and clinical success of procedures, hemodynamic status, quality of life changes, freedom from restenosis and revascularization, amputation-free survival, and overall survival. The study involves follow-up visits over several years to monitor these outcomes and safety.

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