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Completed

NCT Number: NCT00346515

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

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.

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Key information

Conditions

Carotid Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hoag Hospital, Newport Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Tortuous or calcified anatomy proximal or distal to the stenosis
  • Presence of visual thrombus
  • 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.

Treatment and study plan

FiberNet Emboli Protection System

Device

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Lumen Biomedical

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2008
First posted
Jun 30, 2006
Registry last updated
Oct 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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