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The objective of this study is to compare the primary patency of the GORE® VIABAHN® VBX balloon-expandable stent with bare metal stent placement to evaluate superiority in the treatment of complex iliac occlusive disease, with the goal of establishing practical guidelines. about which modality is most appropriate for patients with this condition
FLAGSTAFF, Ariz., Jan. 16, 2024 /PRNewswire/ -- W. L. Gore
"Our team is pleased to be one of the first to enroll patients in this important study," said Dr. Fakhir Elmasri, interventional radiologist at Lakeland Vascular Institute in Lakeland, Florida. "Our first patient had complex bilateral iliac disease and was randomly assigned to treatment with VBX stent grafts. I look forward to the results of the study to inform device selection for long-lasting results in the future."
"Although stenting is common in the treatment of complex iliac occlusive disease, the question of whether to use a covered or uncoated metallic stent remains a matter of debate," said Dr. Prakash Krishnan, an interventional cardiologist at Mount Sinai Hospital. from New York. "This trial is designed to answer the question of whether covered stents are the superior modality among devices commonly used in contemporary practice."
The VBX FORWARD study aims to enroll approximately 244 subjects at 40 centers in the United States, Australia, New Zealand, and Europe, randomly assigning them 1:1 to the VBX stent graft group or the control group (BMS) and conducting follow-up visits. follow-up up to five years after the initial intervention.
"Treatment of complex iliac occlusive disease often poses significant challenges, including tortuous anatomy and calcified lesions with potential for rupture," said Melissa Kirkwood, M.D., professor and chief of Vascular Surgery at the University of Southwestern Medical Center. Texas, Dallas, Texas, and member of the Steering Committee of the VBX FORWARD study. "The results of this important trial will help determine whether the VBX stent graft, with its unique and versatile design, plays a significant role in addressing these challenges."
The VBX stent graft offers precise placement and enables positive outcomes in complex aortoiliac applications.1 Recently published long-term follow-up of patients treated with the VBX stent graft for aortoiliac occlusive disease (AIOD) demonstrates the robustness and durability of the device for five years.1
"Today marks important progress in our continued effort to raise the bar for endovascular treatment outcomes that demonstrate a positive impact on the lives of patients suffering from this disease," said Eric Zacharias, director of the Division of W. L. Gore Medical Products
The GORE® VIABAHN® Device stent-graft family, including the VBX stent-graft and the GORE VIABAHN stent-graft with bioactive heparin surface*,† offers the flexibility and conformability needed to safely and confidently address even the most complex cases.‡ ,2,3
For more information on the GORE VIABAHN Device family of stent grafts, visit: https://www.goremedical.com/viabahn/device-family/devices
More information about the VBX FORWARD study at: https://clinicaltrials.gov/ct2/show/NCT0...
Gore designs medical devices for the treatment of various cardiovascular and other diseases. With more than 55 million medical devices implanted over more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for doctors, hospitals and insurers. Gore is at the service of doctors and thanks to this collaboration we are improving lives. For more information, visit goremedical.com.
W. L. Gore
For complete directions and other important safety information for Gore commercial products referenced in this document, please refer to the applicable instructions for use (IFU).
*As used by Gore, Bioactive Heparin Surface refers to Gore's proprietary CBAS® Heparin Surface.
†Also called the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface in some regions.
‡ The indication for the GORE VIABAHN VBX balloon-expandable stent includes de novo or restenotic lesions in the iliac arteries, including those of the aortic bifurcation. The indication for the GORE VIABAHN endoprosthesis includes only injuries to the iliac arteries. See product instructions.
1. Holden A, Takele E, Hill A, et al. Long-term follow-up of subjects with iliac occlusive disease treated with the Viabahn VBX balloon-expandable stent. Journal of Endovascular Therapy. In press.
2. Piazza M, Squizzato F, Dall'Antonia A, et al. Outcomes of self-expanding PTFE-covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score models. European Journal of Vascular
3. Panneton JM, Bismuth J, Gray BH, Holden A. Three-year follow-up of patients with iliac occlusive disease treated with the Viabahn balloon-expandable stent. Journal of Endovascular Therapy 2020;27(5):728-736.
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GORE, Together, improving life, PROPATEN, VBX and VIABAHN are registered trademarks of W. L. Gore
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