First patients enrolled in the RELINE MAX Viabahn clinical study

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The first patients are now enrolled in the Gore RELINE MAX clinical study, a post-approval study to continue to evaluate the Viabahn endoprosthesis with heparin bioactive surface for the treatment of in-stent restenosis in the superficial femoral artery. Results of the original Gore RELINE clinical study supported the US Food and Drug Administration (FDA) approval of the Viabahn endoprosthesis for the treatment of in-stent restenosis in the superficial femoral artery in 2014.

In-stent restenosis or re-occlusion occurs in a significant number of patients over the course of one year after bare metal stenting, and occurrence rates are highly dependent on the severity of disease. Previous treatment options for in-stent restenosis included angioplasty, repeat stenting with another bare metal stent, and surgical bypass. Viabahn re-lines the failed bare metal stent and adjacent diseased vessel, providing a long-term physical barrier that extends the life of the intervention.

The RELINE MAX study will enrol 108 patients, largely in the USA, with up to a 27cm lesion length in patients who have already failed stenting, making it potentially one of the most difficult patient populations studied with lower limb disease. “By participating in such prospective, multicentre studies, clinicians provide further evidence of the safety and efficacy of the Viabahn endoprosthesis in a challenging group of patients with in-stent restenosis, for whom, until recently, percutaneous treatment options were very limited,” said M Casey Becker, with the Peripheral Structural and Coronary Interventional Therapies Division, St Vincent Heart and Vascular Institute, Portland, USA.

Gore says that the flexibility of the endoprosthesis enables it to traverse tortuous areas of the superficial femoral artery and conform closely to the complex anatomy of the artery. According to a company press release, Viabahn is the lowest profile, most flexible, self-expanding stent-graft available. It is the only stent-graft to receive approval for the superficial femoral artery (de novo, restenotic, and in-stent restenotic disease), iliac artery, and arteriovenous access revision. The device is constructed with a durable, reinforced, biocompatible, expanded ePTFE liner and attached to an external nitinol stent structure. The ePTFE luminal surface of the Viabahn device features the CBAS heparin surface intended to provide sustained thromboresistance.

The results of the original Gore RELINE clinical study, which supported the FDA approval of Viabahn for the treatment of in-stent restenosis in the superficial femoral artery, found that:

  • Subjects in the Viabahn device arm of the Gore RELINE clinical study were approximately three times less likely than those in the percutaneous transluminal angioplasty arm to require a target lesion revascularisation after one year.
  • After 12 months, the Viabahn endoprosthesis showed a primary patency of 74.8%, compared to only 28% for percutaneous transluminal angioplasty (p<0.001).
  • With the longest available 25cm stent-graft, heparin surface, and ePTFE liner, the Viabahn device is a long-lasting solution for treatment of failed bare stents.

“Up until now, when stents failed, at-risk patients were left with limited options. By continuing to study the 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.”