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

NCT00346515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-10-21

No results posted yet for this 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.

Conditions

  • Carotid Artery Stenosis

Interventions

DEVICE

FiberNet Emboli Protection System

Sponsors & Collaborators

  • Lumen Biomedical

    lead INDUSTRY

Principal Investigators

  • J. Michael Bacharach, MD · North Central Heart Institute

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Completion
2008-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00346515 on ClinicalTrials.gov