W.L. Gore & Associates said this week that it launched a post-approval study of its Viabahn stent graft for treating peripheral artery disease.
The 108-patient Reline Max study will examine the treatment of in-stent restenosis in the superficial femoral artery using the Viabahn device, which is designed to inhibit blood clots with its heparin coating.
The Viabahn stent graft, which 1st won FDA approval in 2005, was approved by the safety watchdog for treating in-stent restenosis last year. The Reline Max trial’s primary safety endpoint is procedure- and device-related serious adverse events at 30 days, according to ClinicalTrials.gov, and the primary efficacy endpoint is primary patency without repeat intervention after a year. The trial, estimated to be complete in November 2020, is slated for final data collection in November 2018.
“Up until now, when stents failed, at-risk patients were left with limited options. By continuing to study the Gore Viabahn endoprosthesis in these complex cases, we can best address the need for more successful outcomes in this challenging patient population,” clinical & technical peripheral intervention leader Ben Beckstead said in prepared remarks. “The original Gore Reline clinical study saw great results, and we expect to confirm the benefits of the device for this indication with the Gore Reline Max clinical study.”
“I am thrilled to be one of the many peripheral experts who are bringing patients into the Gore Reline Max Clinical Study,” added Dr. Casey Becker of Erie, Pa.’s St. Vincent Heart & Vascular Institute. “By participating in such prospective, multicenter studies, clinicians provide further evidence of the safety and efficacy of the Gore Viabahn endoprosthesis in a challenging group of patients with in-stent restenosis, for whom, until recently, percutaneous treatment options were very limited.”