CREATE - Carotid Revascularization with ev3 Arterial Technology Evolution Post Approval Study
ID Number 07-1257Principal Investigator(s)
Department(s) or Division(s)
The primary objective of the CREATE PAS is to confirm the safety and effectiveness of the PROTÉGÉ® RX Carotid Stent Systems and SpiderFXTM Embolic Protection Device when used in the treatment of common and/or internal carotid artery stenoses for subjects with a high risk for complications during carotid endarterectomy. While the device is approved for use, the FDA has mandated that a Post-Approval Study be conducted. A subset of these patients would not be eligible for medicare reimbursement of their procedure if they were not participating in this trial. Specifically, asymptomatic patients, and symptomatic patients with stenosis < 70% would be ineligible for medicare payment. The secondary objective is to evaluate rare and unanticipated adverse events among subjects treated with carotid stenting using the PROTÉGÉ Stent with the SpiderFX Device when used in the treatment of common and/or internal carotid artery stenoses for subjects with a high risk for complications during carotid endarterectomy.
Recruiting Patients: Yes