RELINE MAX Postapproval Study of the Viabahn to Treat In-Stent Restenosis in the SFA Begins Enrollment

December 16, 2015—Gore & Associates announced the start of enrollment in the Gore RELINE MAX clinical study, a postapproval study to continue to evaluate the Gore Viabahn endoprosthesis with heparin bioactive surface for the treatment of in-stent restenosis in the superficial femoral artery (SFA). 

According to the company, the Gore RELINE MAX clinical study will enroll 108 patients, largely in the United States. The study population will include patients with up to a 27-cm lesion length who have already failed stenting. 

In Gore’s press release, M. Casey Becker, MD, commented “I am thrilled to be one of the many peripheral experts who are bringing patients into the Gore RELINE MAX clinical study. 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.” Dr. Becker is with the Peripheral Structural and Coronary Interventional Therapies Division at the St. Vincent Heart and Vascular Institute in Erie, Pennsylvania.

The company advised that results of the original Gore RELINE clinical study supported US Food and Drug Administration approval of the Viabahn device for the treatment of in-stent restenosis in the SFA in 2014. The RELINE study found that patients treated with the Viabahn device were approximately three times less likely to require a target lesion revascularization after 1 year than those patients treated with percutaneous transluminal angioplasty (PTA). After 12 months, the Gore Viabahn showed a primary patency of 74.8%, compared to 28% for PTA (P < .001).