EPIC US Pivotal Study (EPIC)

Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Intervention of the Carotid Arteries.
• Intervention / Treatment: Device: Percutaneous intervention of the carotid artery

• Study Type: Interventional
• Enrollment (Actual): 237
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Heart Hospital of South Dakota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Lumen Biomedical
• Investigators: Principal Investigator: J. Michael Bacharach, MD, Heart Hospital of South Dakota; Principal Investigator: Subbarao Mylavarapu, MD, Hoag Hospital

Publications and helpful links

Helpful Links

• Lumen Biomedical website

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: April 11, 2007
• First Submitted That Met QC Criteria: April 11, 2007
• First Posted (Estimate): April 13, 2007

Study Record Updates

• Last Update Posted (Estimate): October 21, 2008
• Last Update Submitted That Met QC Criteria: October 20, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: carotid artery, distal protection device, carotid stenting
• Other Study ID Numbers: 90-1145