Table 2 Inclusion/Exclusion Criteria for the SAPPHIRE Trial of Carotid Stent Placement

Inclusion
    Asymptomatic stenosis >80% or symptomatic stenosis >50% by angiography or ultrasonography and at least one of the following conditions that would result in high surgical risk:
        Age >80 years
        Congestive heart failure (class III/IV) and/or left ventricular ejection fraction <30%
        Open heart surgery needed within 6 weeks
        Recent myocardial infarction (>24 hours and <4 weeks)
        Unstable angina (CCS class III/IV)
        Severe chronic obstructive pulmonary disease
        Contralateral carotid occlusion
        Contralateral laryngeal nerve palsy
        Severe tandem lesions
        Lesions distal or proximal to the usual location
        Previous endarterectomy with restenosis
        Previous radiation therapy or radical neck surgery
Exclusion
    Acute ischemic neurologic event within past 48 hours
    Total occlusion of the target carotid artery
    Surgical or interventional procedure planned within the next 30 days
    Common carotid ostial lesion