The Gore Vibrant study is a randomized, prospective, multi-center clinical trial intended to demonstrate patency superiority in the treatment of lesions eight centimetres or longer with the Gore VIABAHN Endoprosthesis compared to bare nitinol stents. The study enrolled 150 participants at 15 study sites over the course of three years, with patency surveillance via duplex ultrasound at one, six, 12, 24 and 36-month intervals.
An independent core laboratory will interpret results of the follow-up ultrasound imaging studies. Study endpoints focus on primary and secondary patency – the state of vessel blood flow – of the treated artery.
Gary Ansel, co-principal investigator for the Gore Vibrant study, said: “We look forward to the long-term follow-up data of patients and what it could reveal about the impact that adding a bypass-like covering to a stent can have on the results of bare metal stents.”