Status:
COMPLETED
EPIC US Feasibility 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, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00346515
Start Date
June 1 2006
End Date
January 1 2008
Last Update
October 21 2008
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Hoag Hospital
Newport Beach, California, United States, 92658
2
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
3
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
4
North Central Heart Institue
Sioux Falls, South Dakota, United States, 57108