Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy ¿ SAPPHIRE WW IDE # P030047
This study is a patient registry to collect data after angioplasty of the carotid arteries. Angioplasty (a balloon catheter technique) is an effective method of opening the blood vessels in the heart and legs. A stent is a metallic device that behaves like a spring to keep the artery open. The devices that will be utilized are the Cordis PRECISE Nitinol Stent System and the Cordis ANGIOGUARD XP/RX Emboli Capture Guidewire (ECGW). Both of these devices have been approved by the Food and Drug Administration (FDA). Other PRECISE stents that are approved by the FDA in the future may also be used. The primary objective of this study is to estimate 30-day Major Adverse Event rate after stenting (any death, stroke or heart attack).
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