EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting

October 20, 2008 updated by: Lumen Biomedical

Evaluating the Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting: The EPIC US Feasibility Study

Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent in high surgical risk patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92658
        • Hoag Hospital
    • Maryland
      • Takoma Park, Maryland, United States, 20912
        • Washington Adventist Hospital
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • North Central Heart Institue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • Candidate for percutaneous stenting with target lesion located within common or internal carotid artery.
  • Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.

Exclusion Criteria:

  • Allergy to Heparin.
  • Myocardial infarction within the last 14 days.
  • Angioplasty or PTCA/PTA procedure within the past 48 hours.
  • Cardiac surgery within the past 60 days.
  • Planned invasive surgical procedure within 30 days.
  • Stroke within the past 14 days.
  • Transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
  • Intracranial stenosis that exceeded the severity of an extracranial stenosis.
  • Peripheral vascular disease of sufficient severity to prevent vascular access to the target lesion.
  • 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 because of one or more of:

    1. Tortuous or calcified anatomy proximal or distal to the stenosis
    2. Presence of visual thrombus
    3. Pseudo occlusion ('string sign')
  • Serial lesions that requires more then one stent to cover entire lesion.
  • Procedural complication prior to introduction of the FiberNet device into the body.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • 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
All death and all stroke rates; Non-stroke neurological event rates; Technical success rates; Procedural success rates; Access site complication rates

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumen Biomedical

Investigators

  • Principal Investigator: J. Michael Bacharach, MD, North Central Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

June 29, 2006

First Posted (Estimate)

June 30, 2006

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 864

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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