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

Summary

About 20% of stroke causes are atherosclerotic strokes caused by carotid artery stenosis.

In 2005, 92% of carotid artery interventions in the USA were performed in asymptomatic patients. It should be noted that screening in the general population for carotid artery disease is unwarranted, due to uncertain eligibility criteria for interventional treatment of asymptomatic patients. On the other hand, 10-15% of all patients with a first-ever stroke will experience an ischemic stroke as a result of previously untreated, asymptomatic, significant carotid artery stenosis.

Carotid artery angioplasty with stent placement (CAS) has become the second method of revascularization. ed, however, there is a great deal of ambiguity in the application of these criteria, which stems from the ratio of the risk to the possible benefit to the patient of performing the procedure, as well as the cost-effectiveness for health care systems.

OBJECTIVES The overall goal is (following the model of measuring fractional flow reserve - FFR) to try to establish a new parameter that could prove helpful in qualifying patients for percutaneous internal carotid artery angioplasty with stent implantation (CAS). Determining whether measuring the pressure gradient across the stenosis will determine which patients will benefit from the CAS procedure. In the absence of convincing evidence on the effects of CAS, especially for so-called asymptomatic patients, it is advisable to establish a parameter that would complement the eligibility criteria that, on the one hand, could prevent strokes in the population of patients with silent internal carotid artery stenosis and, on the other hand, avoid performing the procedure in the absence of benefit.

PRIMARY ENDPOINTS:

1. Assessment of cerebral perfusion by magnetic resonanse before and after CAS
2. Assessment of cognitive symptoms using before and after CAS
3. Assessment of neurological symptoms before and after CAS
4. Assessment of otolaryngological symptoms before and after CAS

SECONDARY ENDPOINTS:

Creation of a non-invasive computed tomography protocol with pressure gradient assessment in patients with carotid artery stenosis.

A final version of the algorithm based on a new diagnostic measurement (concentration gradient) ready to be used in the diagnosis of CAS-eligible patients with an implemented function for automatic classification of measurement results that will indicate the group of patients who will benefit from the CAS procedure.

Conditions

• Carotid Artery Stenosis
• Carotid Artery Stenting
• Stroke

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

Sponsors & Collaborators

• Medical Research Agency, Poland

  collaborator OTHER_GOV

• 4th Military Clinical Hospital with Polyclinic, Poland

  lead OTHER

Principal Investigators

• Krzysztof Ściborski, MD, PhD · 4th Military Hospital in Wrocław

• Waldemar Banasiak, MD, PhD · 4th Military Hospital in Wrocław

• Artur Telichowski, MD, PhD · 4th Military Clinical Hospital with Polyclinic, Poland

• Adrian Doroszko, MD, PhD · 4th Military Clinical Hospital with Polyclinic, Poland

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• Poland

Study Locations