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

This study has been completed.
Sponsor:
Information provided by:
Lumen Biomedical
ClinicalTrials.gov Identifier:
NCT00346515
First received: June 29, 2006
Last updated: October 20, 2008
Last verified: October 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00346515     History of Changes
Other Study ID Numbers: 864
Study First Received: June 29, 2006
Last Updated: October 20, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014