EPIC US Pivotal Study

Lumen Biomedical

Status

Completed

Conditions

Percutaneous Intervention of the Carotid Arteries.

Treatments

Device: Percutaneous intervention of the carotid artery

Study type

Interventional

Funder types

Industry

Identifiers

NCT00460187

90-1145

Details and patient eligibility

About

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.

Enrollment

237 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.