EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting

The purpose of this feasibility study is to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention. The feasibility study will involve a maximum of 50 subjects to be enrolled using the FiberNet® during clinically indicated percutaneous intervention of the carotid artery and followed through 30 days post procedure. Subject will be enrolled in up to 5 European Investigational Sites. The study is a prospective multi-center registry with sequential enrollment of qualified subjects who consent to participate and meet all entrance criteria.

Inclusion criteria

• Candidate for percutaneous stenting with target lesion located within common or internal carotid artery.
• Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
• Targeted vessel diameter for FiberNet placement between 1.75 mm and 7.0 mm.
• The investigator determines that all branch vessels distal to the target lesion and proximal to the proposed site of device deployment will be adequately protected.

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.
• Has a planned invasive surgical procedure within 30 days.
• Suffered a stroke within the past 14 days.
• Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
• Total occlusion of the target vessel.
• Lesions within 2 cm of the ostium of the common carotid artery.
• A stenosis that is known to be unsuitable for stenting because of one or more of: Tortuous or calcified anatomy proximal or distal to the stenosis, Presence of visual thrombus, Pseudo occlusion (string sign).
• Serial lesions that requires more then one stent to cover entire lesion.