CREATE

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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.

Clinical Criteria

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  

Anatomical Criteria

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