The purpose of this study was to evaluate the feasibility, safety and midterm outcome of elective implantation of the Carotid Wallstent in patients considered to be at high surgical risk. In a prospective study, 54 carotid artery stenoses in 51 patients were stented over a 24-month period. Three patients underwent bilateral carotid artery stenting. Institutional inclusion criteria for invasive treatment of carotid occlusive disease (carotid endarterectomy or carotid artery stenting) are patients presenting with a 70% or more symptomatic stenosis and those with an 80% or more asymptomatic stenosis having a life-expectancy of more than 1 year. All patients treated by carotid artery stenting were considered at high risk for carotid endarterectomy because of a hostile neck (17 patients--31.5%) or because of severe comorbidities (37 patients--68.5%). No cerebral protection device was used. Of the 54 lesions, 33 (61.1%) were symptomatic and 21 (38.8%) were asymptomatic. Follow-up was performed by physical examination and by duplex ultrasonography at 1 month, 6 months, 1 year and 2 years after the procedure. All 54 lesions could be stented successfully without periprocedural stroke. Advert events during follow-up (mean 13.9 +/- 5.7 months) were non-stroke-related death in 6 patients (11.1%), minor stroke in 4 stented hemispheres (7.4%), transient ipsilateral facial pain in 1 patient (1.8%), infection of the stented surgical patch in 1 patient (1.8%) and asymptomatic instent restenosis in 4 patients (7.4%). The percutaneous implantation of the Carotid Wallstent, even without cerebral protection device, appears to be a safe procedure with acceptable clinical and ultrasonographic follow-up results in patients at high surgical risk. But some late adverse events such as ipsilateral recurrence of non-disabling (minor) stroke or instent restenosis still remain real challenging problems.