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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


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

See also
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Recruiting NCT01440036 - The Correlation Between the Enzyme Paraoxigenase 1 (PON1) to Carotid Artery Atheromatous Plaque N/A
Completed NCT00417963 - ViVEXX Carotid Revascularization Trial (VIVA) Phase 3
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Recruiting NCT02006095 - Neuroimaging Correlates of Memory Decline Following Carotid Interventions N/A
Terminated NCT01236508 - Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease Phase 4
Recruiting NCT03464851 - Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis N/A
Recruiting NCT03495830 - Stratification of Patient With Carotid Disease
Terminated NCT00597545 - Effect of Raised CBF During CEA on Cognition in DM Patients N/A
Completed NCT00309803 - EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting N/A
Completed NCT00597883 - Neuropsychometric Outcome After Carotid Endarterectomy N/A
Not yet recruiting NCT01547039 - Platelet Reactivity and MES During CEA N/A
Recruiting NCT01718600 - Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions N/A
Completed NCT00677963 - Contrast-enhanced Ultrasound (CE-US) and Magnetic Resonance Imaging (MRI): Evaluating Plaque Neovascularisation N/A
Completed NCT02800174 - Smart Nitinol Stent System for the Treatment of Severe Atherosclerotic Carotid Stenosis N/A
Terminated NCT00335972 - The Effects of Dexmedetomidine and Remifentanil on Carotid Patients Phase 4
Completed NCT00346515 - EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting N/A