EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting
NCT ID: NCT00346515
Last Updated: 2008-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2006-06-30
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Interventions
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FiberNet Emboli Protection System
Eligibility Criteria
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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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Lumen Biomedical
INDUSTRY
Principal Investigators
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J. Michael Bacharach, MD
Role: PRINCIPAL_INVESTIGATOR
North Central Heart Institute
Locations
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Hoag Hospital
Newport Beach, California, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
North Central Heart Institue
Sioux Falls, South Dakota, United States
Countries
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Other Identifiers
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864
Identifier Type: -
Identifier Source: org_study_id