Status:
COMPLETED
EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting
Lead Sponsor:
Lumen Biomedical
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multicenter, prospective, study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet Embolic Protection System as an adjunctive device during carotid artery percut...
Detailed Description
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 percu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00309803
Start Date
March 1 2006
Last Update
October 21 2008
Active Locations (3)
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1
Dortmund, Germany
2
Frankfurt, Germany
3
Hamburg, Germany