EPIC US Pivotal Study

Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.

Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients.

Inclusion Criteria:

• One or more of the high surgical risk criteria.
• Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.

Exclusion Criteria:

• Prior stenting of ipsilateral carotid.
• Planned treatment of contralateral carotid within 30 days.
• Experienced a myocardial infarction within the last 14 days.
• Undergone an angioplasty or PTCA/PTA procedure within the past 48 hours.
• Undergone cardiac surgery within the past 60 days.
• Suffered a stroke within the past 14 days.
• Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
• Abnormal baseline blood counts; platelets <50,000 or >700,000/mm3 or WBC count < 3 x103/uL.
• Intracranial stenosis that exceeded the severity of an extracranial stenosis.
• Total occlusion of the target vessel.
• Lesion within 2cm of the ostium of the common carotid artery.
• A stenosis that is known to be unsuitable for stenting
• Serial lesions that requires more than one stent to cover entire lesion.