Table 2.

Inclusion and exclusion criteria for participant selection.

Inclusion criteria
1.	Patient age ≥18 and ≤ 79 years old (upper age limit was added March 2004. .
2.	Symptomatic patient, as evidenced by transient ischemic attack (TIA), amaurosis fugax, minor or non-disabling stroke (in the hemisphere supplied by the target vessel) within 180 days of the treatment date, or asymptomatic patients meeting angiographic criteria (≥70% stenosis).
3.	Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.
4.	Patient and the patient's physician agree to have the patient return for all required clinical contacts following study enrollment.
5.	Patient has been informed of the nature of the study, and has provided written informed consent.
6.	Patient has a discrete lesion located in the internal carotid artery (ICA) (with or without involvement of the contiguous common carotid artery (CCA)).
7.	Carotid stenosis ≥50% defined by angiography in symptomatic patients or ≥70% in asymptomatic patients (based on NASCET Criteria.)
8.	Target ICA vessel reference diameter must be measured to be ≥4.0 mm and ≤9.0 mm. Target ICA may be reasonably estimated by angiography of the contralateral artery.
9.	Expected ability to deliver the stent to the lesion (absence of excessive tortuosity).
Exclusion criteria
1.	Patient has an evolving stroke.
2.	Patient has history of intolerance or allergic reaction to any of the study medications, including aspirin (ASA), ticlopidine and clopidogrel. (Patients must be able to tolerate a combination of ASA and ticlopidine OR ASA and clopidogrel)
3.	Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusions.
4.	Patient with a history of major ipsilateral stroke likely to confound study endpoints.
5.	Patient has severe dementia.
6.	Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
7.	Patient has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.
8.	Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
9.	Patient has Hgb <10 g/dl, platelet count <125,000/µl, uncorrected INR >1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia.
10.	Patient has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe. (e.g., morbid obesity, sustained SBP >180 mm Hg.)
11.	Patient has had neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke (e.g. partial or secondarily generalized seizures; complicated or classic migraine; tumor or other space-occupying brain lesions; subdural hematoma, cerebral contusion or other post-traumatic lesions; intracranial infection; demyelinating disease; moderate to severe dementia; or intracranial hemorrhage).
12.	If a patient has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery, he/she will be considered an asymptomatic patient for the lead-in phase of the study.
13.	Knowledge of cardiac sources of emboli (e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).
14.	Chronic atrial fibrillation, known by history or present on entry examination.
15.	Any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
16.	Patient has had a MI within previous 30 days.
17.	Patient has had a recent GI bleed that would interfere with antiplatelet therapy.
18.	Severe vascular tortuosity or anatomy that would preclude the safe introduction of a guiding catheter, guiding sheath, or stent placement.
19.	Presence of a previously placed intravascular stent or graft in the ipsilateral distribution.
20.	Presence of extensive or diffuse atherosclerotic disease involving the aortic arch and proximal common carotid artery that would preclude the safe introduction of a guiding catheter or guiding sheath.
21.	An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) that is not associated with an ulcerated target lesion.
22.	Ipsilateral intracranial or extracranial arterial stenosis greater in severity than the lesion to be treated, cerebral aneurysm ≥5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings that constitute contraindication to CAS.
23.	Bilateral carotid stenosis if intervention is planned within the 30-day periprocedure period.
24.	Occlusion [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] “string sign” >1 cm of the ipsilateral common or internal carotid artery.
25.	Well-delineated carotid artery dissection below the carotid siphon.
26.	Ostial lesion of LCCA/RCCA.