CLINICAL TRIALS
FiberNet® Clinical Trials
UNITED STATES
EPIC Pivotal Study
Evaluating the Use of the FiberNet Embolic Protection Device in Carotid Artery Stenting
This is a multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients. The primary endpoint of the study is the rate of all death, all stroke, and myocardial infarction within 30 days of the procedure. A number of secondary endpoints will also be evaluated.
Status: Enrollment Complete
Result: View Document
FORTRESS
Sponsored by VIVA Physicians, Inc. FORTRESS is a prospective, single-arm multi-center feasibility trial of renal artery distal protection using the Lumen Biomedical FiberNet® Embolic Protection System in patients with atherosclerotic renal artery stenosis. The study enrolled 20 patients at 5 Clinical Centers.
Study Title: FiberNet® Renal Artery Embolic Protection Study; A Prospective, singlearm feasibility trial of renal artery distal protection using the Lumen Biomedical FiberNet® Embolic Protection System in patients with atherosclerotic renal artery stenosis.
Study Objective: To evaluate the procedural safety and filter efficiency of the FiberNet® Embolic Protection System when used in conjunction with the Boston Scientific Express SD Stent System for primary stenting of ostial atherosclerotic renal lesions in patients with atherosclerotic renal artery stenosis.
Status: Completed on January 12, 2010.