Status:
COMPLETED
EPIC US Pivotal Study
Lead Sponsor:
Lumen Biomedical
Conditions:
Percutaneous Intervention of the Carotid Arteries.
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery ...
Eligibility Criteria
Inclusion
- One or more of the high surgical risk criteria.
- Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
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.
- Suffered a stroke within the past 14 days.
- Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
- Abnormal baseline blood counts; platelets \<50,000 or \>700,000/mm3 or WBC count \< 3 x103/uL.
- Intracranial stenosis that exceeded the severity of an extracranial stenosis.
- 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
- Serial lesions that requires more than one stent to cover entire lesion.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00460187
Start Date
March 1 2007
End Date
June 1 2008
Last Update
October 21 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hoag Hospital
Newport Beach, California, United States, 92663
2
Heart Hospital of South Dakota
Sioux Falls, South Dakota, United States, 57108