Carotid Artery Disease - EPIC US - PIVOTAL

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Trial Sponsor
Lumen Biomedical

Principal Investigator
Krishna Rocha-Singh, MD

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

Purpose
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.

Eligibility

Ages Eligible for Study
18 years and above

Genders Eligible for Study
Both

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 because of one or more of:
1. Tortuous or calcified anatomy proximal or distal to the stenosis
2. Presence of visual thrombus
3. Pseudo occlusion (‘string sign’)
• Serial lesions that requires more than one stent to cover entire lesion

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