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.
The principal investigators for this study are J. Michael Bacharach, MD (Heart Hospital of South Dakota, Sioux Falls, SD) and Subbarao Mylavarapu, MD (Hoag Hospital, Newport Beach, CA).
For more information about the clinical trial contact Lumen Biomedical.
Status: Enrollment Complete
Trial Design: http://www.clinicaltrials.gov/ct/show/NCT00460187
RETRIEVE Feasibility Study
Evaluating the Use of the FiberNet Embolic Protection System in Saphenous Vein Grafts
This is a multicenter, prospective study designed to demonstrate the performance and safety of the FiberNet Embolic Protection System when used as an adjunctive device during Saphenous Vein Graft (SVG) intervention.
For more information about the clinical trial contact Lumen Biomedical.
Status: Enrollment Complete
Trial Design: http://www.clinicaltrials.gov/ct/show/NCT0045351
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 will enroll 20 patients at 5 Clinical Centers.
Status: Enrolling
Trial Design: http://clinicaltrials.gov/ct2/show/NCT00674505
INTERNATIONAL
NET-PV
Novel Embolic Protection Trial - Peripheral Vasculature
The purpose of this study was to evaluate the performance and safety of the FiberNet Embolic Protection System as an adjunctive device in the treatment of carotid and renal artery stenosis. This study enrolled participants under the direction of Professors Antonios Polydorou (Athens, Greece) and Michel Henry (Nancy, France).
Status: Enrollment Complete
Status: Ongoing
Trial Design: http://www.clinicaltrials.gov/ct2/show/NCT00674505