Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: Protection Against Emboli During caRotid Artery Stenting Using a Neuroguard IEP� Direct 3-in-1 Delivery System Comprised oF a pOst-dilation Balloon, integRated eMbolic Filter, and A Novel Carotid stEn
Brief Summary:
The PERFORMANCE III study is a prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP� Direct System for the treatment of carotid artery stenosis in subjects at elevated risk for carotid endarterectomy (CEA).
Eligible patients greater than or equal to 20 years of age and less than or equal to 80 years of age, are those who have been diagnosed with either de-novo atherosclerotic or post CEA restenotic lesion(s) in the internal carotid arteries (ICA) or at the carotid bifurcation with greater than or equal to 50% stenosis if symptomatic or greater than or equal to 70% stenosis if asymptomatic.