W. L. Gore & Associates tells us the first patients are now enrolled in its Gore RELINE MAX Clinical Study, a post-approval 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).
Background
In-stent restenosis or re-occlusion occurs in a significant number of patients over the course of one year after bare metal stenting for peripheral vascular disease. Until recently, in-stent restenosis treatments included angioplasty, repeat stenting with another bare metal stent (BMS), and surgical bypass. GORE says its VIABAHN Device changes the current treatment paradigm for in-stent restenosis by re-lining the failed BMS and adjacent diseased vessel, providing a long-term physical barrier that extends the life of the intervention. The flexibility of the device enables it to traverse tortuous areas of the SFA and conform closely to its complex anatomy. As the lowest profile, most flexible, self-expanding stent-graft available, the system is an obvious target for clinical study to evaluate the extent of its value in improving patient outcomes and reducing healthcare costs.
Results of the original Gore RELINE Clinical Study supported the FDA approval of the GORE VIABAHN Endoprosthesis for the treatment of in-stent restenosis in the SFA in 2014.
The new Gore RELINE MAX Clinical Study will enroll 108 patients, largely in the US, with up to a 27 cm lesion length in patients who have already failed stenting, making it potentially one of the most difficult patient populations studied with lower limb disease.
Investigator comments
“I am thrilled to be one of the many peripheral experts who are bringing patients into the Gore RELINE MAX Clinical Study,” said M. Casey Becker, MD, with the Peripheral Structural and Coronary Interventional Therapies Division, St. Vincent Heart and 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.”
Company comments
“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,” said Ben Beckstead, Clinical and Technical Peripheral Interventional Business Unit Leader. “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.”
Source: Business Wire
published: December 16, 2015 in: Clinical Studies/Trials, Vascular