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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346515
First Posted: June 30, 2006
Last Update Posted: October 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lumen Biomedical
  Purpose
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.

Condition Intervention
Carotid Artery Stenosis Device: FiberNet Emboli Protection System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluating the Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting: The EPIC US Feasibility Study

Further study details as provided by Lumen Biomedical:

Primary Outcome Measures:
  • The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.

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

Estimated Enrollment: 30
Study Start Date: June 2006
Study Completion Date: January 2008
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346515


Locations
United States, California
Hoag Hospital
Newport Beach, California, United States, 92658
United States, Maryland
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, South Dakota
North Central Heart Institue
Sioux Falls, South Dakota, United States, 57108
Sponsors and Collaborators
Lumen Biomedical
Investigators
Principal Investigator: J. Michael Bacharach, MD North Central Heart Institute
  More Information

ClinicalTrials.gov Identifier: NCT00346515     History of Changes
Other Study ID Numbers: 864
First Submitted: June 29, 2006
First Posted: June 30, 2006
Last Update Posted: October 21, 2008
Last Verified: October 2008

Keywords provided by Lumen Biomedical:
carotid artery
carotid stenosis
carotid stenting
embolic protection

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases