carotid with bivalirudin angioplasty

Conditions: Carotid Artery Disease

Summary: 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.


Eligibility criteria:
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 (\ 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