EPIC US Pivotal Study

Not Applicable

Completed

• Conditions: Percutaneous Intervention of the Carotid Arteries.

• Registration Number: NCT00460187
• Lead Sponsor: Lumen Biomedical

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 percutaneous intervention in high surgical risk patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-11
• Study First Submitted QC: 2007-04-11
• Study First Posted: 2007-04-13
• Study Completion: 2008-06
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-20
• Last Update Posted: 2008-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints are: all death and all stroke rates, non-stroke neurological event rates, technical success rates, procedural success rates, and access site complication rates.

Trial Locations

Locations (2)

Heart Hospital of South Dakota; 🇺🇸 Sioux Falls, South Dakota, United States

Hoag Hospital; 🇺🇸 Newport Beach, California, United States