Continued progress in the VIBRANT (VIaBahn® (endoprosthesis) veRsus bAre Nitinol stenT) Study of comparative treatments for peripheral arterial disease (PAD) of the superficial femoral artery (SFA) was announced by W. L. Gore & Associates. Sponsored by Gore, the VIBRANT Study is a randomized, prospective, multi-center clinical trial intended to demonstrate mid- and long-term superior performance in the treatment of SFA lesions eight centimeters or longer with the GORE VIABAHN® Endoprosthesis compared to bare nitinol stents.
Gary Ansel, co-principle investigator on the VIBRANT Study and an interventional cardiologist at Riverside Methodist Hospital in Columbus, Ohio, presented a study update from the podium at the International Symposium on Endovascular Therapy (ISET). Dr. Ansel reported that combined data from both arms of the study is showing a very low 30 Day Major Adverse Events (MAE) including no early thrombosis. Dr. Ansel stated that “This study is demonstrating that both treatment options have a good early safety profile and a low 30-day Target Lesion Revascularization (TLR).”
The study investigators report that the number of study sites has increased to 16, which has helped patient enrollment approach the halfway mark of the trial. “VIBRANT will allow physicians to understand the appropriate treatment and follow-up for patients with PAD,” said Dr. Ansel.
The VIBRANT study will follow patients for three years with surveillance via duplex ultrasound at 1, 6, 12, 24, and 36-month intervals. An independent core laboratory will interpret results of the follow-up ultrasound imaging. Study endpoints will be centered on primary and secondary patency – the state of vessel blood flow – of the treated lesion. Study investigators include vascular surgeons, interventional radiologists and interventional cardiologists. The core lab will also review flat-film x-rays annually to assess for stent fractures. For a list of study sites and to download a patient brochure, visit www.goremedical.com/vibrantstudy.
“We are encouraged by the continued enthusiasm of the study sites to participate in the VIBRANT study,” said Melissa Brookshier, product specialist for the GORE VIABAHN® Endoprosthesis. “The purpose of the study is to demonstrate that a flexible stent graft is the optimal treatment option for long lesions in the SFA, and we’re pleased that so many physicians are coming together to help evaluate the comparative effectiveness of VIABAHN and bare stents for the treatment of long lesion SFA occlusive disease.”
The GORE VIABAHN® Endoprosthesis is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. Worldwide, more than 70,000 GORE VIABAHN® Endoprostheses have been implanted.
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 23 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery. Gore was recently named the tenth best company to work for by Fortune magazine.
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