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

Study Overview
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Brief Summary
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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.

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

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Device: FiberNet Emboli Protection System


Participation Criteria
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Eligibility Criteria
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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: 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. Procedural complication prior to introduction of the FiberNet device into the body.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FiberNet Emboli Protection System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of all death, all stroke and myocardial infarction within 30 days of the procedure. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All death and all stroke rates; Non-stroke neurological event rates; Technical success rates; Procedural success rates; Access site complication rates |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid artery, carotid stenosis, carotid stenting, embolic protection