Innovative Application of Pressure Gradient Measurement in Internal Carotid Stenosis in Patients Undergoing CAS

NANot yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2027

Conditions
Carotid Artery StenosisCarotid Artery StentingStroke
Interventions
PROCEDURE

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"

PROCEDURE

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."

DIAGNOSTIC_TEST

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)

RADIATION

Angio-CT of the neck and head

Non-invasive pre-operative assessment and post-CAS result (3 months after)

OTHER

Otolaryngological examination

Hearing and balance tests (before and after CAS) - prospective follow-up

OTHER

Psychological examination

psychological examination with questionnaires (before and after CAS) - prospective follow-up

OTHER

Neurological examination

neurological examination with questionnaires (before and after CAS) - prospective follow-up

DIAGNOSTIC_TEST

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"

Trial Locations (1)

50-981

4th Military Hospital, Wroclaw

Sponsors
All Listed Sponsors
collaborator

Medical Research Agency, Poland

OTHER_GOV

lead

4th Military Clinical Hospital with Polyclinic, Poland

OTHER

NCT06123767 - Innovative Application of Pressure Gradient Measurement in Internal Carotid Stenosis in Patients Undergoing CAS | Biotech Hunter | Biotech Hunter