Gore announces two trials to assess Viabahn and Propaten devices.
WL Gore & Associates has announced the creation of two new studies, each designed to collect important data about the performance of heparin-bonded vascular grafts in treating lower-limb peripheral vascular disease (PVD).
The new Gore VIPER (Gore VIabahn Endoprosthesis with Heparin Bioactive Surface for SuPERficial Femoral Artery Endoluminal Bypass) Study is a prospective, single-arm, multi-center evaluation of the recently-approved Gore Viabahn Endoprosthesis with Heparin Bioactive Surface, the only stent-graft of its kind approved for treating the superficial femoral artery (SFA). Gore VIPER Study aims to collect important performance data of the heparin-bonded device. While the Gore Viabahn Endoprosthesis has consistently been shown to be clinically effective in treating SFA disease, there is no data available on its performance when utilizing the Heparin Bioactive Surface. The principal investigator for the study is Dr Richard Saxon, Tri-City Medical Center, Oceanside, CA.
The new Gore PRODIGY (Comparison of Primary Patency Between Gore PROpaten Vascular Graft and DIsadvantaged Autologous Vein Graft for Below-Knee Arterial BYpass) Study is a post-marketing study with the Gore Propaten Vascular Graft, the only ePTFE-heparin combination cleared in the US for surgical bypass and has shown promising results in the reduction of thrombosis in pre-clinical testing. Gore PRODIGY Study is a prospective, randomized, multi-center study designed to demonstrate noninferiority in patency performance of the Gore Propaten Vascular Graft as compared to disadvantaged autologous vein graft in a below-knee peripheral bypass application. The study will provide insights into performance benchmarks of autologous veins and prosthetic bypasses. The patients will be followed-up for a period of three years and will be evaluated for several other secondary outcomes including safety, quality of life and limb salvage. The principal investigator for the study is Dr Richard Neville, Georgetown University Medical Center, Washington, DC. Earlier this year, the company received FDA approval to begin the REVISE and AVIATOR studies. The Gore REVISE (VasculaR AccEss ReVision with Gore Viabahn EndoproSthesis vs. PercutanEous Transluminal Angioplasty) Study, is a randomized, multi-center clinical trial intended to establish efficacy and safety of the Gore Viabahn Endoprosthesis with Propaten Bioactive Surface to revise arterio-venous grafts at the venous anastomosis in hemodialysis patients. The study will randomize patients to the Gore Viabahn Endoprosthesis and to percutaneous transluminal angioplasty (PTA). The AVIATOR (Angioplasty vs. Gore VIAbahn Endoprosthesis Treatment Of GRaft Stenosis) study, is a randomized, multi-center clinical trial intended to establish efficacy and safety of the Gore Viabahn Endoprosthesis with Propaten Bioactive Surface to revise arteriovenous grafts at the venous anastomosis in hemodialysis patients. The study will randomize patients to the Gore Viabahn Endoprosthesis and to percutaneous transluminal angioplasty (PTA). Enrollment for both studies was expected to begin in the third quarter of 2007.