The Gore VIPER Patient Registry is a prospective, single-arm, multi-center evaluationof the GORE VIABAHN^® Endoprosthesis with Heparin Bioactive Surface in the treatment of superficial femoral artery obstructive disease that will collect important performance data of the device. Forty subjects have been enrolled at six centers in the US. Subjects will be followed for one year.

The Gore REVISE Clinical Study is a randomized, multi-center IDE trial in the US intended to establish efficacy and safety of the GORE VIABAHN^® Endoprosthesis with PROPATEN Bioactive Surface to revise arterio-venous (AV) grafts at the venous anastomosis in hemodialysis patients. The study will randomize patients to the GORE VIABAHN^® Endoprosthesis with PROPATEN Bioactive Surface and to percutaneous transluminal angioplasty (PTA). The study will involve approximately 280 subjects, 140 subjects in each treatment arm, at 30 sites. Subjects will be followed for a period of two years. To date, 10 sites are active and 11 subjects have been enrolled. Site start-up and initiation visits are continuing. GORE VIABAHN^® Endoprosthesis with PROPATEN Bioactive Surface is based on the proprietary end-point covalent bonding of heparin to expand polytetrafluoroethylene first made commercially available by Gore with GORE PROPATEN^® Vascular Graft.

The Gore PRODIGY Clinical Study is a prospective, randomized, multi-center study to compare the performance of the GORE PROPATEN^® Vascular Graft, which features the anticoagulant drug heparin, to a disadvantaged autologous vein graft in a below-knee peripheral bypass application. The study will enroll approximately 280 patients throughout the US. The subjects will be followed for a period of three years and will be evaluated for primary patency, as well several other secondary outcomes, including safety, quality of life and limb salvage.