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EPIC US Pivotal Study

NCT00460187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2008-10-21

No results posted yet for this study

Summary

Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients.

Conditions

  • Percutaneous Intervention of the Carotid Arteries.

Interventions

DEVICE

Percutaneous intervention of the carotid artery

Sponsors & Collaborators

  • Lumen Biomedical

    lead INDUSTRY

Principal Investigators

  • J. Michael Bacharach, MD · Heart Hospital of South Dakota

  • Subbarao Mylavarapu, MD · Hoag Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Completion
2008-06-30

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 NCT00460187 on ClinicalTrials.gov