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

Evaluating the Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting: The EPIC US Feasibility Study

Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent in high surgical risk patients.

Inclusion Criteria:

• One or more of the high surgical risk 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.

Exclusion Criteria:

• Allergy to Heparin.

• Myocardial infarction within the last 14 days.

• Angioplasty or PTCA/PTA procedure within the past 48 hours.

• Cardiac surgery within the past 60 days.

• Planned invasive surgical procedure within 30 days.

• Stroke within the past 14 days.

• Transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.

• Intracranial stenosis that exceeded the severity of an extracranial stenosis.

• Peripheral vascular disease of sufficient severity to prevent vascular access to the target lesion.

• 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 then one stent to cover entire lesion.

• Procedural complication prior to introduction of the FiberNet device into the body.