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