BEACH

A prospective, single-arm, multicenter trial to evaluate the safety and efficacy of the Monorail® Carotid Wallstent® Endoprosthesis in conjunction with the FilterWire EX® and FilterWire EZ™ Embolic Protection Systems in the treatment of selected high-risk surgical patients with stenosis of the carotid artery. Success of this study will be assessed by comparison to an Objective Performance Criteria.

Objective:	Evaluate safety and efficacy of the Monorail Carotid Wallstent Endoprosthesis in conjunction with the FilterWire EX and FilterWire EZ Embolic Protection Systems for the treatment of carotid artery stenosis in patients at high-risk for carotid endarterectomy (CEA).
Number of Patients:	747 (Roll-In = 189; Pivotal = 480; Bilateral Registry = 78)
Lesion Type:	Native Common Carotid Artery (CCA), Internal Carotid Artery (ICA) or Carotid Bifurcation; 30-50 mm length; 4.0-9.0 mm vessel diameter
Stent Platform:	Monorail Carotid Wallstent Endoprosthesis
Release Kinetics:	NA
Primary Endpoint:	One year composite endpoint, defined as cumulative morbidity & mortality: =24 hours: Non Q-wave MI =30 days: All death, all stroke, Q-wave MI >30 days and = one year: ipsilateral stroke or neurological death
P.I. and Co-P.I.:	Christopher White, MD Sriram Iyer, MD
Status:	Enrollment Complete