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Purpose: To compare outcomes for two nonrandomized cohorts of patients with high-grade carotid disease who underwent either unprotected carotid stenting or stent implantation protected by the NeuroShield filter., Methods: Under this protocol, symptomatic patients with carotid stenoses >70% or asymptomatic patients with bilateral carotid stenoses who were being evaluated for coronary artery bypass grafting were eligible for carotid stenting. Between December 1998 and November 2001, 75 consecutive patients (57 men; median age 67 years range 45-85) underwent carotid stenting without cerebral protection; concurrently, 75 carotid stent procedures protected with the NeuroShield filter were performed in 73 patients (51 men; median age 66 years, range 47-83). A neurologist reviewed all patients before and after treatment. The groups were comparable for age, sex, and symptoms, but the protected group had a higher proportion of postsurgical restenoses (14.7% versus 1.3%; p=0.003). Outcome measures included death and neurological events at 24 hours and 30 days., Results: There were minor technical difficulties in 12 of the protected group, but none were clinically relevant. The procedural all-stroke/death rates in the unprotected versus protected groups, respectively, were 5.3% (4/75) and 2.7% (2/75; p=0.681), while the disabling stroke/death rates were 4% (3/75) and 1.3% (1/75; p=0.620). At 30 days, the all-stroke/death rates were 10.7% (8/75) in the unprotected group and 4.0% (3/75) in the protected group (p=0.117); the death/major-disability-from-stroke rates were 6.7% (5/75) and 2.7% (2/75), respectively (p=0.442)., Conclusions: Filter-related complications are well tolerated. Neuroprotection devices have the potential to reduce the procedural neurological event rate. Larger series and/or randomized trials are required for further evaluation.