Carotid With Bivalirudin Angioplasty
Carotid With Bivalirudin Angioplasty
Single center randomized clinical trial, to evaluate the safety and efficacy of carotid
 artery stenting using the RX ACCULINK™ Carotid Stent System with RX ACCUNET™ Embolic
 Protection System or PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System
 using Angiomax (bivalirudin)versus heparin as the anticoagulant for treatment of occlusive
 carotid artery disease in low and high risk patient cohorts.
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