EPIC US Pivotal Study

Completed · Not applicable

Conditions studied: Percutaneous Intervention of the Carotid Arteries.

In brief

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 percutaneous intervention in high surgical risk patients.

Key facts

Study ID: NCT00460187
Run by: Lumen Biomedical
People needed: 237
Starts: 2007-03-01
Expected to finish: 2008-06-01
Last updated by the study team: 2008-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Hoag Hospital — Newport Beach, California, United States
Heart Hospital of South Dakota — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.