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PROximal Protection VErsus NON-Protection in Carotid Artery Stenting

NCT01331473 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2011-12-05

No results posted yet for this study

Summary

To compare the incidence of new ischemic brain injury detected with magnetic resonance imaging (MRI) after carotid artery stenting in patients treated with and without proximal cerebral protection (Gore Flow Reversal System).

Conditions

  • Carotid Artery Stenosis

Interventions

PROCEDURE

Carotid Artery Stenting with Proximal Protection

Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System

PROCEDURE

Carotid Artery Stenting without Protection

Carotid artery angioplasty and stenting without cerebral embolic protection

Sponsors & Collaborators

  • Universität des Saarlandes

    lead OTHER

Principal Investigators

  • Wolfgang Reith, MD · Saarland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • Germany

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 NCT01331473 on ClinicalTrials.gov