Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Evaluate the safety and efficacy of the Protege Stent and Spider Device in the treatment of
 common and/or internal carotid artery stenoses for subjects that are high risk for carotid
 endarterectomy.
Inclusion Criteria:

 -  18 years and above

 -  informed consent

 -  for female subjects, not pregnant or planning on becoming pregnant

 -  meet protocol defined anatomical or clinical high risk criteria

 Exclusion Criteria:

 -  participation in another clincial study which may affect either the pre-procedure or
 follow-up results

 -  prior stenting of the ipsilateral carotid artery

 -  life expectancy less than twelve months

 -  known allergy or intolerance of study medications or device materials

 -  must not meet general or angiographic exclusion criteria as defined in the protocol