The Vascular Disease Research Center
at Rhode Island Hospital

Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy (SAPPHIRE-WW)

The SAPPHIRE-WW study is a multi-center clinical trial whose primary objective is to estimate the 30-day major adverse event (MAE) rate of stenting with distal protection in the treatment of carotid artery disease in high surgical risk patients. Major adverse events are classified as any death, stroke, or myocardial infarction (heart attack). Patients are followed for a period of one year and observations are made at four time points: baseline, discharge, 16-45 days post procedure, and 12 months post procedure. The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems and the Cordis ANGIOGUARDTM XP Emboli Capture Guidewire (ECGW).

The current incidence of stroke in Europe and the U.S.A. is about 200 per 100,000 population per annum.  Eighty percent of strokes are ischemic and 20% are due to hemorrhage.  Approximately half of the patients with ischemic stroke have carotid stenosis and about one third (10% of all stroke victims) have no warning symptoms, such as transient ischemic attack (TIA). Clinical symptoms in atherosclerotic carotid artery stenosis are caused by embolic disease in more than 80% of patients, and in less than 20% by hemodynamic impairment of cerebral circulation. The treatment options for patients with carotid stenosis include Carotid endarterectomy, angioplasty, and stenting. To date, over 2000 endovascular carotid stent procedures have been performed worldwide with a reported technical success rate of 98.6%. The periprocedural risks for major and minor strokes and death are comparable to endarterectomy, and stenting is being seen as an alternative to surgery.

The study population will consist of high-surgical risk patients with atherosclerotic disease of the carotid artery(ies). There will be approximately 275 clinical sites from the US, Canada, Latin America, Europe, and Asia Pacific participating in the study, enrolling up to 10,000 patients.

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