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GORE Embolic Protection With Reverse Flow

NCT00594100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2013-12-27

Study results available
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Summary

To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.

Conditions

  • Carotid Artery Stenosis

Interventions

DEVICE

GORE Flow Reversal System (GFRS)

Carotid artery angioplasty and stenting with embolic protection

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Daniel Clair, M.D. · The Cleveland Clinic

  • L. N. Hopkins, M.D. · Millard Fillmore Gates/Univ. of Buffalo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-09-30
Completion
2008-09-30

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 NCT00594100 on ClinicalTrials.gov