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Carotid Revascularization with ev3 Arterial Technology Evolution Post Approval Study (CREATE PAS)
High risk patients, symptomatic or asymptomatic ev3 Protégé and SpideRx 30 day 1000, 1 year 500 Prospective, non-randomized, multi site 30 day SDMI and 1 year ipsi stroke, to confirm safety and effectiveness
The subject must meet at least ONE or more high-risk criterion in EITHER the clinical or anatomical section.
Age >75 CCS angina class 3-4 or unstable angina CHF class III-IV LVEF <35% MI <6 weeks Coronary artery disease with > 2 vessel disease in major vessel & history of angina Severe pulmonary disease – home oxygen, resting pO2 <60 or FEV <50%8. Permanent contralateral cranial nerve injury
Contralateral occlusion High cervical lesion (above the angle of the jaw) Infraclavicular lesion Tandem lesions >80% Hostile neck (cervical radiation treatment, tracheostomy/stoma, or radical neck dissection) CEA restenosis Cervical immobility due to fusion or arthritis Bilateral carotid stenoses, both requiring treatment