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Innovative Application of Pressure Gradient Measurement in Internal Carotid Stenosis in Patients Undergoing CAS
Condition(s) studied
Carotid Artery StenosisCarotid Artery StentingStroke
Investigational drug(s) / intervention(s)
CAS + Intravascular measuring the pressure gradientCAS (standard)Doppler ultrasonound of cephalic arteriesAngio-CT of the neck and headOtolaryngological examinationPsychological examinationNeurological examinationMR cerebral perfusion
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
Study 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.
Eligibility
Inclusion Criteria:
* Stenosis of the internal carotid artery in symptomatic patients: \> 50%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation
* Stenosis of the internal carotid artery in asymptomatic patients: \>60%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation
* Age of patients: \> 18 years of age
* Provided informed consent to participate in the study.
Exclusion Criteria:
* Inability to obtain informed consent to participate in the study.
* Difficult anatomy of the aortic arch and the descending cephalic arteries (increased atherosclerotic lesions, acute angle of departure of the common carotid arteries, kinking of the internal carotid arteries).
Primary outcome measure(s)
- Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on changes in cerebral perfusion after surgery — 3 months
Composite endpoint including:
Assessment of the predictive capabilities of the obtained pressure gradient values
* on changes in cerebral perfusion after surgery (assessment of the cerebral perfusion alterations using DSC (dynamic susceptibility contrast) MR perfusion, before and after CAS
- Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on neurological status — 12 months
Composite endpoint including:
\- changes in neurological status (assesed by the MMSE, mini-mental state examination; NIHSS, National Institutes of Health Stroke Scale),
- Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on mental status — 12 months
Composite endpoint including:
\- changes in cognitive functions (assesed by the MOCA, Montreal Cognitive Assessment - test)
- Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on otolaryngological status in hearing functions — 12 months
Composite endpoint including:
\- changes in hearing functions (assesed by the audiometry, tympanometry and ipsilateral middle ear reflex, otoemission, Skarzynski Tinnitus Scale, ABR - Auditory Brainstem Response, BERA)
- Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on otolaryngological status in labyrinth functions — 12 months
Composite endpoint including:
\- changes in labyrinth functions (assesed by the Skarzynski Tinnitus Scale)
- Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on MACEs after surgery — 12 months
Composite endpoint including:
\- occurence of stroke/TIA or death
- Repeatability the diagnostic possibilities of non-invasive tests (Doppler ultrasound) in invasive pressure gradient values — 12 months
Composite endpoint including:
\- comparison of the obtained invasive pressure gradient values with Doppler ultrasound (PSV, peak systolic velocity; EDV, end-diastolic velocity; estimated degree of stenosis)
- Repeatability the diagnostic possibilities of non-invasive tests (CT angiogram) in invasive pressure gradient values — 12 months
Composite endpoint including:
\- comparison of the obtained invasive pressure gradient values with angio-CT: degree of stenosis
- Repeatability the diagnostic possibilities of non-invasive tests ("CT-FFR") in invasive pressure gradient values — 12 months
Composite endpoint including:
\- comparison of the obtained invasive pressure gradient values with "CT-FFR" (planned creation of an algorithm based on test results: invasive pressure gradient, Doppler ultrasound, angio-CT)
- Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (1) — 12 months
Composite endpoint including:
\- occurrence of periprocedural neurological event: TIA, stroke, death in patients who underwent CAS with the invasive intravascular pressure measurement procedure
- Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (2) — 12 months
Composite endpoint including:
\- occurrence of another periprocedural complication: vascular spasm, perforation, cardiac arrhythmia, hypotonia/hypertension in patients who underwent CAS with the invasive intravascular pressure measurement procedure
- Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (3) — 12 months
Composite endpoint including:
\- occurrence of new hypodense (impact) foci in the head CT scan after the procedure in patients who underwent CAS with the invasive intravascular pressure measurement procedure
- Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (4) — 12 months
Composite endpoint including:
\- changes (improvement or deterioration) in brain perfusion (see point 1.) in the post-operative examination in patients who underwent CAS with the invasive intravascular pressure measurement procedure
Trial sites (1)
| Facility | City | Region | Status |
|---|
| 4th Military Hospital |
Wroclaw |
Lower Silesian Voivodeship |
|
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