200
Participants
Start Date
April 1, 2024
Primary Completion Date
July 31, 2027
Study Completion Date
July 31, 2027
CAS + Intravascular measuring the pressure gradient
"Measurements taken during the procedure during CAS~* placement of a FFR- micro catheter on the neuroprotection wire and taking a measurement before the stenosis and in the internal carotid artery above the stenosis~* reading the pressure gradient after obtaining a stable value (a minimum of 5 cardiac cycles)~ * the study of intravascular pressure measurements will be performed using a special micro catheter"
CAS (standard)
"Animation of blood pressure measurements on the FFR console without actual measurement in carotid artery (blinding of the study to the patient) during CAS procedure."
Doppler ultrasonound of cephalic arteries
non-invasive assessment of carotid stenosis before surgery and assessment of results after CAS (3 and 12 months after CAS)
Angio-CT of the neck and head
Non-invasive pre-operative assessment and post-CAS result (3 months after)
Otolaryngological examination
Hearing and balance tests (before and after CAS) - prospective follow-up
Psychological examination
psychological examination with questionnaires (before and after CAS) - prospective follow-up
Neurological examination
neurological examination with questionnaires (before and after CAS) - prospective follow-up
MR cerebral perfusion
"Assessment of the cerebral perfusion alterations using DSC (dynamic susceptibility contrast) MR perfusion, before and after CAS (after 3 months):~Parametric maps of cerebral blood flow (CBF), cerebral blood volume (CBV), time to peak (TTP), and mean transit time (MTT) will be generated and used for the qualitative and quantitative analyses of the following perfusion parameters:~* cerebral blood volume (CBV) value in ml/100ml;~* cerebral blood flow (CBF) value in ml/100ml/min;~* mean transit time (MTT) value in seconds~* time to peak (TTP) value in seconds"
4th Military Hospital, Wroclaw
Collaborators (1)
Medical Research Agency, Poland
OTHER_GOV
4th Military Clinical Hospital with Polyclinic, Poland
OTHER