Carotid Artery Stenosis Clinical Trial
Official title:
Badanie Kliniczne oceniające bezpieczeństwo i skuteczność Stosowania stentów Szyjnych MER® w Rewaskularyzacji tętnic Szyjnych.
The aim of the study is to confirm, whether the MER® stent can be used, without limitations, for the endovascular carotid stenosis treatment in daily clinical practice. Eligible patients will undergo the procedure of the common or internal carotid artery stenting using MER® with proximal or distal neuroprotection.
MER® stent will be implanted in eligible patients with common and internal carotid stenosis
after an informed consent.
Potential benefit of the MER® stent implantation will be evaluated based on angiography and
duplex Doppler ultrasound examination.
Follow ups are scheduled at 30 days, 6 and 12 months after index procedure. Except for
clinical follow up patients will undergo carotid vessels ultrasound examination after 6 and
12 months. In case of an emergency visit, caused by the Serious Adverse Event, Patient will
undergo: neurological and cardiac evaluation as well as carotid vessels USG examination and
extended CT or MRI scans.
In general, all procedures in the study will follow the local standard of care. The type of
devices used during the angioplasty (including the MER® stents) will not differ from the
devices used in the usual clinical practice in the hospital. DAPT and other medical therapy
will be consistent with the rules of the Polish and European Society of Cardiology.
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