Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)
Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)
The purpose of this study is to determine whether morbidity and mortality for high-risk
 surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX
 and EZ System distal protection device will be less than or equal to that of objective
 performance criteria (OPC) derived from historic controls undergoing surgical intervention
 with a carotid endarterectomy (CEA).
Stroke is the third leading cause of death in this country with approximately 600,000 new
 stroke cases each year. Mortality rates as high as 40 percent have been reported for stroke
 as a result of ischemia associated with the carotid distribution. Currently, the primary
 therapy for carotid artery occlusive disease is carotid endarterectomy (CEA) or the surgical
 removal of atheromatous material from inside the artery.

 Although CEA is an effective treatment for the majority of patients with carotid occlusive
 disease, there remains a need for a treatment option for those patients with significant
 surgical risk factors. These patients have been shown to have much higher rates of morbidity
 and mortality. There are approximately 50,000-70,000 patients each year who are considered
 poor surgical candidates. These patients present with either one or more anatomical or
 co-morbid conditions and have a one-year stroke and death rate of up to 15% with traditional
 surgical treatment.

 Carotid artery stenting (CAS) has been reported by numerous single-center trials to be
 feasible in the treatment of carotid artery stenosis. Moreover, the risk benefit ratio has
 been suggested to be the largest in those patients with a higher risk profile for the CEA
 treatment option.

 This trial will study the effects of percutaneous intervention using the Monorail™ Carotid
 Wallstent® Endoprosthesis (Carotid Wallstent) in conjunction with the FilterWire System
 distal protection device (FilterWire EX and EZ) on rates of common peri-procedural
 complications as well as on long-term outcomes as compared to historical outcomes of patients
 undergoing CEA.
Key General Inclusion Criteria:

 -  Patient must meet criteria for either A or B:

 A. Symptomatic: Carotid stenosis of greater than or equal to 50% via angiography with
 associated cerebral or retinal TIA or ischemic stroke symptoms within 180 days of the
 procedure, which are determined to have occurred in the cerebral hemisphere or eye
 ipsilateral to the target carotid artery lesion and to be reasonably attributable to that
 lesion; or

 B. Asymptomatic: Carotid stenosis greater than or equal to 80% via angiography without
 associated cerebral or retinal TIA or ischemic stroke symptoms within 180 days of the
 procedure.

 -  Target lesion is in the native common carotid artery (CCA), internal carotid artery
 (ICA), or carotid bifurcation.

 -  Target arterial segment to be stented has a diameter of greater than or equal to 4.0
 mm to less than or equal to 9.0 mm.

 -  Vessel diameter distal to the target lesion is greater than or equal to 3.5 mm and
 less than or equal to 5.5 mm as an optimal "landing zone" for placement of the
 FilterWire EZ System with visual angiographic recommendations as described in the
 instructions for use (IFU).

 Key High-Risk Eligibility Inclusion Criteria:

 -  Patients must qualify in at least one high-risk category. The high-risk categories are
 defined as:

 -  Anatomical conditions [one (1) criterion qualifies]

 -  Co-morbid conditions Class I [one (1) criterion qualifies]

 -  Co-morbid conditions Class II [two (2) criteria qualify]

 Exclusion Criteria:

 -  Patient has experienced an evolving, acute, or recent stroke within 21 days of study
 evaluation.

 -  A total occlusion of the ipsilateral carotid artery. (Only for Roll-In and Pivotal
 patients.)

 -  A total occlusion of the contralateral carotid artery. (Only for Bilateral Registry
 patients.)

 -  Pre-existing stent(s):

 -  Roll-In and Pivotal Patients: located within the ipsilateral carotid
 distribution; a stent was placed in a contralateral vessel within the previous 30
 days of the study enrollment.

 -  Bilateral Registry Patients: located within the carotid distribution.

 -  A target lesion which is expected to require more than one stent.

 -  Known cardiac sources of emboli of a type likely to be associated with cerebral
 ischemic events [e.g. endocarditis, intracardiac thrombus, embolic-associated
 cardiovascular lesions, or any current arrhythmia (e.g. atrial fibrillation, atrial
 flutter, etc.)].

 -  Myocardial infarction (MI) within 72 hours prior to the index procedure, defined as
 creatine kinase (CK)-MB > 2 X the local laboratory's upper limit of normal (ULN).

 -  Any surgery requiring general anesthesia (e.g. coronary artery bypass graft [CABG],
 valve replacement, or abdominal aortic aneurysm) less than or equal to 30 days
 preceding the stent procedure.

 -  The patient is enrolled in another investigational study protocol and has not
 completed the required follow-up period of the evaluation. The patient may not
 participate in another investigational study that may confound the treatment or
 outcomes of the BEACH protocol.