Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting

The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with embolic protection studies

Patient registry procedures include:

* Clinical Events Committee (CEC); responsibility for validating all reported primary safety outcomes
* Data Safety Monitoring Board (DSMB); to review and evaluate safety data including serious adverse events
* 100% data monitoring; to compare data entered into the registry
* Source data verification; to assess the accuracy, completeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms).
* Standard Operating Procedures; to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis and reporting for adverse events.
* Sample size assessment to specify the number of participants and follow up duration.
* Data Management Plan; to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
* Statistical analysis plan; describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Anticipated patient life expectancy of at least 1 year
* Patient or authorized representative, signed a written Informed Consent form
* Patient is willing to comply with the protocol requirements
* Candidate for catheter-based therapy of a single stenosis located in the internal carotid artery (ICA) or the carotid bifurcation, suitable for treatment with a single FDA-approved stent with a carotid use indication
* Reference vessel diameter for intended filter location between 3.5mm and 6.0mm
* An adequate "landing zone" of at least 30mm
* Patients with severe symptomatic or asymptomatic carotid artery stenosis, to be ≥ 50% for symptomatic patients OR ≥ 80% for asymptomatic patients
* At least one high surgical risk criteria, either anatomical or co-morbid risk factors, as listed below:

Category I - Anatomical high risk factors

* Recurrent stenosis after endarterectomy
* Previous radical neck surgery or radiation therapy to the neck
* High cervical ICA lesions or CCA lesions at or above C2 or below the clavicle
* Spinal immobility of the neck
* Tracheostomy or tracheal stoma
* Any laryngeal nerve palsy and bilateral carotid artery stenosis

Category II - Co-morbid risk factors

* Contralateral carotid occlusion
* Unstable angina (Canadian Cardiovascular Society class III/IV)
* Congestive Heart Failure (New York Heart Association functional class III/IV) and/or known severe left ventricular dysfunction LVEF\<30%
* Requires coronary artery bypass surgery, cardiac valve surgery, major vascular surgery, or abdominal aortic aneurysm repair 31-60 days post carotid stent procedure
* Recent MI (\>72 hr and \<4 weeks)
* Severe pulmonary disease with FEV1 of \<30%
* CAD in ≥2 unrevascularized vessels with stenosis ≥70%
* Age ≥75 years
* Uncontrolled diabetes - Female patient with no child bearing potential or has negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study

Exclusion Criteria:

* Total occlusion or near-occlusion of the target vessel
* Severe lesion calcification
* Presence of an alternate source of emboli
* Presence of a filling defect, or angiographically visible thrombus, at target site
* A greater than 50% CCA lesion proximal to the target or a distal (intracranial) lesion more severe than the target lesion
* Evolving, acute or recent stroke within the last 30 days
* Major stroke with a residual neurological deficit that would confound neurologic assessment
* Vertebrobasilar insufficiency symptoms only
* Major operation 30 days before or after the index procedure
* Ipsilateral intracranial stenosis that requires treatment
* Any pre-existing stent in ipsilateral carotid artery, or placement of a stent in contralateral carotid within 30 days of the index procedure
* History of intracranial hemorrhage within 12 months
* Any condition that precludes proper angiographic assessment or prevents femoral arterial access
* Uncontrolled hypertension
* Contraindication to heparin and bivalirudin, aspirin, thienopyridines
* Known sensitivity to radiographic contrast media which cannot be controlled with pre-medication
* History or current indication of bleeding diathesis or coagulopathy
* Chronic renal insufficiency
* Carotid artery dissection or aortic arch anatomical anomalies
* Dementia or a neurological illness
* Patient is enrolled in another drug or device study protocol that has not reached its primary endpoint
* Severe pulmonary hypertension
* Intra-cranial pathology (e.g., tumor, AVM. aneurysm, etc) that would make study participation inappropriate or confound neurologic assessment