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CompletedNCT00346515Updated Oct 21, 2008

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

An interventional study of FiberNet Emboli Protection System in Carotid Artery Stenosis, sponsored by Lumen Biomedical. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-21.

Sponsored by Lumen Biomedical · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Carotid Artery Stenosis

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Keywords

  • carotid artery
  • carotid stenosis
  • carotid stenting
  • embolic protection
03

In context

Carotid Stenosis

349 studies on the registry are indexed under Carotid Stenosis; 82 are open to participants now.

This study's enrollment of 30 is below the median of 104 across 188 interventional studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Lumen Biomedical is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants

Interventions

  • DeviceFiberNet Emboli Protection System
06

What researchers measure

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

07

Study locations

4 sites
  • Hoag Hospital
    Newport Beach, California 92658, United States
  • Washington Adventist Hospital
    Takoma Park, Maryland 20912, United States
  • Riverside Methodist Hospital
    Columbus, Ohio 43214, United States
  • North Central Heart Institue
    Sioux Falls, South Dakota 57108, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2006 and a completion of Jan 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2006
First posted
Jun 30, 2006
Start
Jun 2006
CompletionActual
Jan 2008
Last update
Oct 21, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 21, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00346515
Lead sponsor
Lumen Biomedical
First posted
Jun 30, 2006
Start date
Jun 2006
Completion
Jan 2008
Last update
Oct 21, 2008

Study contacts

J. Michael Bacharach, MD
principal investigator · North Central Heart Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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