Kurzfassung

Primary Objective and Endpoint:
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.
The protocol initially specified MRI scans to take place 1–7 days before treatment (pretreatment scan), 1–3 days after treatment (post-treatment scan). Diffusion-weighted imaging (DWI) sequences were used at each scan to...Primary Objective and Endpoint:
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.
The protocol initially specified MRI scans to take place 1–7 days before treatment (pretreatment scan), 1–3 days after treatment (post-treatment scan). Diffusion-weighted imaging (DWI) sequences were used at each scan to detect acute ischaemic brain lesions. Fluid-attenuated inversion recovery (FLAIR) sequences were used at pretreatment scans to measure cerebral white matter changes.
Two neuroradiologists, both masked to treatment, analysed all scans. Disagreement was resolved by consensus or, if no consensus could be reached, a third reviewer had the final decision. On each scan, the number, vascular territory according to previously published templates, and volume of hyperintense lesions on DWI, signifying acute cerebral ischaemia, were measured. Volumes of separate lesions were calculated by measuring lesion diameters in three axes, converted to mL. Lesions were considered separate if there was no continuity between them on the same slice as well as on adjacent slices.
The primary imaging outcome was the presence of any new hyperintense DWI lesion on the post-treatment scan that was not present on the pretreatment scan.


Secondary Objective:
Impact of MRI-morphology of atherosclerotic plaque to the rate of new hyperintense DWI lesion on the post-treatment scan and to the rate of ipsilateral stroke or death.
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