Carotid With Bivalirudin Angioplasty

Inclusion Criteria:

- The patient must be at least 18 years of age.

- The patient must have a significant diameter reduction of the extracranial or
intracranial internal or common carotid artery, defined as ≥50% stenosis for
symptomatic patients or ≥80% stenosis for asymptomatic patients determined by carotid
duplex ultrasound scan and/or carotid angiography.

- Female patients with child bearing potential must have a negative pregnancy test.

- The patient and the patient's physician must agree to have the patient return for a
30-day and one-year clinical and ultrasound imaging follow-up evaluations as indicated
in the protocol.

- Reference vessel diameter ≥ 3.5 mm - ≤ 9.0 mm diameter.

Exclusion Criteria:

- The patient has had a recent (<4 weeks) disabling stroke or dementia with major
neurologic deficit (stroke scales: Barthel <60, NIH >15, or Rankin >3) at
pre-procedure neuro exam.

- The patient has had within four weeks of the treatment procedure an intracranial
hemorrhage, hemorrhage stroke, major stroke, or any stroke with mass effect
demonstrated on MRI or CT.

- The patient has a known allergy to heparin, bivalirudin, aspirin or to anti-platelet
agents that prevents taking aspirin plus ticlopidine or aspirin plus clopidogrel.

- The patient has received fractionated or unfractionated heparin within 8 hours prior
to the procedure.

- The patient has a history of prior life-threatening radiocontrast reaction that cannot
be pre-treated.

- The patient has a history of bleeding diathesis or coagulopathy within 3 months.

- The patient is currently participating in another study protocol that may influence
either procedure results or follow-up evaluations.

- Plasma/serum creatinine > 3.0 mg/dl at time of intervention.

- Hemodynamic instability at the time of intervention.

- Previous stent placement in the ipsilateral carotid distribution.

Angiographic Exclusion Criteria

- The patient has an intracranial tumor, or cerebral arterio-venous malformation(s) >
5mm, aneurysms or severe intracranial stenosis distal to target lesion.

- The patient has inaccessible intracranial arterial stenosis greater in severity than
the extracranial internal carotid artery lesion.

- There is angiographic evidence of significant intra-luminal thrombus burden with
presumed increased risk of plaque fragmentation and consequent distal embolization.

- There is total occlusion of the ipsilateral carotid artery treatment site with TIMI 0
flow characteristics.

- The reference segment diameter (internal carotid artery segment cephalad to the
lesion) is less than 3 millimeters by operator visual estimate.

- The patient has peripheral vascular, supra-aortic or internal carotid artery
tortuosity precluding use of catheter-based techniques required for successful CSSA