EPIC US Pivotal Study
Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients.
Percutaneous Intervention of the Carotid Arteries.
Device: Percutaneous intervention of the carotid artery
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.|
- The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.
- Secondary Endpoints are: all death and all stroke rates, non-stroke neurological event rates, technical success rates, procedural success rates, and access site complication rates.
|Study Start Date:||March 2007|
|Study Completion Date:||June 2008|
|United States, California|
|Newport Beach, California, United States, 92663|
|United States, South Dakota|
|Heart Hospital of South Dakota|
|Sioux Falls, South Dakota, United States, 57108|
|Principal Investigator:||J. Michael Bacharach, MD||Heart Hospital of South Dakota|
|Principal Investigator:||Subbarao Mylavarapu, MD||Hoag Hospital|