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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System
Carotid artery angioplasty and stenting without cerebral embolic protection
Department of Diagnostic and Interventional Neuroradiology
Homburg, Saarland, Germany
RECRUITINGThe detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging
Time frame: Day 1-3
Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment
Time frame: Day 30
Technical Success of the procedure
Subjects (both groups) who due to technical reaseons are unable to performe carotid artery stenting will be considered as technical failures. Subjects who are unable to tolerate flow reversal (in group 2) and have their procedures completed without embolic protection or other methods will be also considered as technical failures.
Time frame: Day 0
Access site vascular complications, defined as need for surgical repair or blood transfusion
Time frame: Day 0-7
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