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PROximal Protection VErsus NON-Protection in Carotid Artery Stenting — PROVENON  

Carotid Artery Stenosis Clinical Trial

Official title:
PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON Study) A Randomized Prospective MRI-based Trial.

Clinical Trial 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).

Clinical Trial Description

Primary Objective:

The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting between patients treated with proximal cerebral protection (Gore Flow Reversal System) and without cerebral protection.

Secondary Objective:

Impact of MRI-morphology of atherosclerotic plaque to the rate of new hyperintense diffusion weighted imaging (DWI) lesion on the post-treatment scan and to the rate of ipsilateral stroke or death. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01331473
Study type Interventional
Source Saarland University
Contact Panagiotis Papanagiotou, MD
Phone +49684116
Email provenon.study@me.com
Status Recruiting
Phase Phase 3
Start date May 2011
Completion date June 2014
View Details
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