A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin)

Inclusion Criteria:

• Patient (male or non-pregnant female)must be > than or= 18

• Qualifying non-invasive test (ultrasound or MRA) was performed less than 60 days prior to study entry. Carotid duplex study revealed:

  • Stenosis > or = to 50% in symptomatic patients
  • Stenosis > or = to 60% in asymptomatic patients
• Target lesion may be in the common or internal carotid artery and is amenable to treatment with angioplasty and stenting
• Patients taking warfarin may be included if their dosage is reduced before the procedure to result in an INR of 1.5 or less and a Prothrombin time of 15 seconds. Warfarin may be started after the procedure.
• Female patients of childbearing potential must have a documented negative pregnancy test during index hospitalization
• Patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board or medical ethics committee

Exclusion Criteria: (Patients will be excluded from the study if ANY of the following conditions are present)

• There is total occlusion of the target carotid artery treatment site.
• The patient has an allergy or contraindication to aspirin, ticlopidine, clopidogrel, bivalirudin, nickel, titanium, or a sensitivity to contrast media, which cannot adequately pre-medicated.
• The subject has a platlet count< 100,000 cells/mm3 or 700,000 cells/mm3 or a WBC of < 3,000 cells/mm3.
• Stroke within 7 days prior to the procedure
• NIH stroke score > or = to 15 within 7 days prior to the procedure
• The patient has experienced a significant GI bleed within 6 months prior to study procedure
• The patient has active internal bleeding
• The patient has had major surgery or serious trauma within 6 weeks before enrollment
• The patient has excessive peripheral vascular disease that precludes safe sheath insertion
• The patient has had an intracranial hemorrhage, hemorrhagic stroke, major stroke or any stroke within one week of index procedure
• The patient has concurrent emboligenic cardiovascular disease not adequately treated with anticoagulant therapy
• The patient is on renal dialysis
• The patient has had low molecular weight heparin (LMWH) administered within 8 hours or less, prior to the procedure
• Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry(BP> 180/110mmHG)
• The patient is unable or unwilling to cooperate with the study follow-up procedures