Gore VBX FORWARD Clinical Study Enrolls First Patients

January 16, 2024—Gore & Associates announced that the first patients have been enrolled in the Gore VBX FORWARD clinical study.

The global prospective, multicenter, randomized controlled trial is comparing the company’s Viabahn VBX balloon expandable endoprosthesis—the VBX stent graft—versus bare metal stents (BMSs) for the treatment of patients with complex iliac occlusive disease. The company first announced the initiation of the trial in June 2023.

According to the company, the VBX FORWARD study aims to enroll an estimated 244 patients across 40 sites in the United States, Australia, New Zealand, and Europe. Patients will be randomized 1:1 to the VBX stent graft group or the BMS control group. The investigators will conduct follow-up visits through 5 years from the initial procedure.

The study aims to compare primary patency with the VBX stent graft to BMS to evaluate superiority with the goal of informing practice guidelines around which modality is best suited for patients with this condition.

“Our team is pleased to be among the first to enroll patients in this important study,” commented Fakhir Elmasri, MD, in Gore’s press release.

Dr. Elmasri, who is an interventional radiologist at Lakeland Vascular Institute in Lakeland, Florida, continued, “Our first patient presented with complex, bilateral iliac disease and was randomized to treatment with VBX stent grafts. I look forward to seeing the results of the study to inform device selection for durable outcomes in the future.”

Prakash Krishnan, MD, an interventional cardiologist at The Mount Sinai Hospital in New York, New York added, “While stenting is common when treating complex iliac occlusive disease, the question around whether to use a covered or bare metal stent remains a source of debate. This trial is designed to answer the question as to whether covered stents are the superior modality among commonly used devices in contemporary practice.”

Melissa Kirkwood, MD, who is Professor and Chief of Vascular Surgery at University of Texas Southwestern Medical Center in Dallas, Texas, and VBX FORWARD Study Steering Committee Member.

“Treating complex iliac occlusive disease often comes with significant challenges, including tortuous anatomy and calcified lesions with the potential for rupture,” commented Dr. Kirkwood in the press release. “The outcomes of this important trial will help determine whether the VBX stent graft, with its unique and versatile design, plays a meaningful role in addressing these challenges.”

The company stated that the VBX stent graft offers precise delivery in the treatment of complex aortoiliac applications. Long-term follow-up of patients treated with the VBX stent graft for aortoiliac occlusive disease demonstrated the robustness and durability of the device through 5 years.

In April 2023, 5-year follow-up clinical data underscoring the long-term robustness and durability of the Viabahn VBX device to treat patients with iliac occlusive disease were published by Andrew Holden, MD, et al online in Journal of Endovascular Therapy, noted the company.