OBJECTIVE Carotid artery stenting (CAS) for treatment of carotid stenosis has not received wide acceptance because of the availability of carotid endarterectomy (CEA) with its excellent results and because of the risk of embolic stroke associated with CAS. The feasibility and efficacy of cerebral protection devices that may prevent such embolic complications have yet to be shown. We report our initial results with CAS performed with cerebral protection. METHODS For a period of 28 months, 31 patients with carotid artery stenosis, most of whom were considered at high risk for CEA (87%), underwent treatment with CAS in conjunction with either the PercuSurge GuardWire (n = 19; Medtronic, Minneapolis, Minn), the Cordis Angioguard filter (n = 7; Cordis, Warren, NJ), or the ArteriA Parodi Anti-embolization catheter (n = 4; ArteriA, San Francisco, Calif) with US Food and Drug Administration-approved investigational device exemptions. Factors that made CEA high risk included restenosis after CEA (n = 6), hostile neck (n = 6), high or low lesions (n = 4), and severe comorbid medical conditions (n = 11). Preoperative neurologic symptoms were present in 58%, and the mean stenosis was 85% +/- 12%. Data were prospectively recorded and analyzed on an intent-to-treat basis. Neurologic evaluation was performed before and after CAS by a protocol neurologist. RESULTS CAS was performed with local anesthesia with the Wallstent (n = 23; Boston Scientific Corp, Natick, Mass) or the PRECISE carotid stent (n = 7; Cordis) in conjunction with one of the protection devices in an operating room with a mobile C-arm. Each patient received dual antiplatelet therapy before surgery. The overall technical success rate was 97% (30/31). In one patient, the lesion could not be crossed with a guidewire because of a severely stenosed and tortuous lesion. This patient was not a candidate for CEA and was treated conservatively. In the remaining 30 cases, CAS had a good angiographic result (residual stenosis, <10%). All patients tolerated the protection device well, and no intraprocedural neurologic complications occurred. Macroscopic embolic particles were recovered from each case. One patient (3%) with a severely tortuous vessel had a major stroke immediately after CAS, and no deaths occurred. The combined 30 day stroke/death rate was 3%. During a mean follow-up period of 17 months, one subacute occlusion of the stent occurred but did not result in a stroke. Three other patients had duplex scan-proven in-stent restenosis, and two underwent treatment with repeat percutaneous transluminal angioplasty with a good result. No patient had a stroke during the follow-up period. CONCLUSIONS CAS with cerebral protection devices can be performed safely with a high technical success rate. Although many patients who underwent treatment with CAS were at high risk, the neurologic complication rate was low and CAS appears to be an acceptable treatment option for select patients at high risk for CEA. Tight lesions and tortuous anatomy may make the use of distal protection devices difficult. Further study is warranted.