Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™

Inclusion Criteria

• •patient is greater than or equal to 18 years of age.
• •Anticipated patient life expectancy is of at least one year from the date of the index procedure.
• •Lesion is located in the common carotid artery (CCA) and/or the internal carotid artery (ICA) or the carotid bifurcation.
• •Target vessel is the only vessel being treated at this intervention and the lesion is less than or equal to 30 mm and can be treated with a single stent.
• •Vessel to be treated is between 4.0 mm and 9.0 mm in diameter.
• •Patient can be either symptomatic or asymptomatic; Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke, TIA and/or amaurosis fugax in the hemisphere supplied by the target vessel within 180 days of the procedure.
• •Patient can be either symptomatic or asymptomatic; Asymptomatic: Stenosis must be greater than or equal to 60% as determined by angiogram without any neurological symptoms.
• •Distal vessel "landing zone" for placement of the FilterWire must be between 3.5 mm and 5.5 mm in diameter with visual angiographic recommendations as described in the IFU.
• •Female patients with no childbearing potential or a documented negative pregnancy test (urine or blood) within 10 days of the index procedure.
• •Patient (or their legal guardian) understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
• •Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations
• •Patient must fulfill at least one of the following Class I: Unstable angina, LVEF less than 30%, CHF class III or class IV, dialysis dependent renal failure, severe COPD, requirement for staged CABG or valve replacement post carotid index procedure,Previous carotid endarterectomy with significant restenosis, total occlusion of the contralateral carotid artery, Previous radiation treatment to the neck or radical neck dissection, Target lesion is at or above the second vertebral body C2 or below the clavicle, Inability to extend the head due to cervical arthritis or other cervical disorders, Tracheostomy or tracheal stoma,Presence of laryngeal nerve palsy, Bilateral carotid artery stenosis as determined by angiography.
• •If a patient does not meet Class I criteria, a patient must meet two of the follwing class II criteria: Patient is greater than or equal to 75 years of age, Myocardial infarction within previous 6 weeks, Requires staged peripheral vascular surgery (i.e. abdominal aortic aneurysm repair) or other major surgery post carotid index procedure, Two or more proximal or major diseased coronary arteries with greater than or equal to 70% stenosis that have not or cannot be revascularized.