An interventional study of CAS + Intravascular measuring the pressure gradient and CAS (standard) in Carotid Artery Stenosis, Carotid Artery Stenting and Stroke, sponsored by 4th Military Clinical Hospital with Polyclinic, Poland. Not yet recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by 4th Military Clinical Hospital with Polyclinic, Poland · Not applicable, Interventional, and Diagnostic
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:
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.
After qualification for the study (by a neurologist and vascular surgeon), patients meeting properly the inclusion and exclusion criteria will be referred for imaging studies with Doppler ultrasound, angio-CT scan of the arteries of the neck and head and cerebral perfusion in magnetic resonanse (assessment of the cerebral perfusion alterations using DSC (dynamic susceptibility contrast).
In addition, blood will be drawn and stored for subsequent testing. Afterwards, patients qualified for internal carotid artery angioplasty procedures will receive standard saturation treatment with two antiplatelet drugs (acetylsalicylic acid, clopidogrel) before the procedure, strictly according to the guidelines. The procedures are carried out with approved medical equipment (carotid stent, angioplasty balloon, peripheral neuroprotection). The selection of the appropriate equipment used for the procedure depends on the clinical situation, the experience of the operator and the anatomical conditions of the carotid arteries.
Measurements (invasive pressure in carotid artery) taken during the procedure before angioplasty (after insertion of the neuroprotection into the internal carotid artery) and after stent implantation:
COURSE OF THE STUDY
Baseline examination:
Measurements (invasive pressure) taken during the procedure before angioplasty (after insertion of the neuroprotection into the internal carotid artery) and after stent implantation:
reading the pressure gradient after obtaining a stable value (a minimum of 5 cardiac cycles)
Evaluation during treatment:
339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.
This study's planned enrollment of 200 is above the median of 106 across 182 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →4th Military Clinical Hospital with Polyclinic, Poland is the lead sponsor of 9 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with internal carotid stenosis qualified for angioplasty with stent implantation. Standard CAS procedure with additional intravascular pressure measurements
Procedure: CAS + Intravascular measuring the pressure gradient · Procedure: CAS (standard) · Diagnostic Test: Doppler ultrasonound of cephalic arteries · Radiation: Angio-CT of the neck and head · Other: Otolaryngological examination · Other: Psychological examination · Other: Neurological examination · Diagnostic Test: MR cerebral perfusion
Patients with internal carotid stenosis qualified for angioplasty with stent implantation. Standard CAS procedure.
Procedure: CAS (standard) · Diagnostic Test: Doppler ultrasonound of cephalic arteries · Radiation: Angio-CT of the neck and head · Other: Otolaryngological examination · Other: Psychological examination · Other: Neurological examination · Diagnostic Test: MR cerebral perfusion
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
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.
non-invasive assessment of carotid stenosis before surgery and assessment of results after CAS (3 and 12 months after CAS)
Non-invasive pre-operative assessment and post-CAS result (3 months after)
Hearing and balance tests (before and after CAS) - prospective follow-up
psychological examination with questionnaires (before and after CAS) - prospective follow-up
neurological examination with questionnaires (before and after CAS) - prospective follow-up
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
Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on changes in cerebral perfusion after surgery
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
Time frame: 3 months
Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on neurological status
Composite endpoint including: - changes in neurological status (assesed by the MMSE, mini-mental state examination; NIHSS, National Institutes of Health Stroke Scale),
Time frame: 12 months
Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on mental status
Composite endpoint including: - changes in cognitive functions (assesed by the MOCA, Montreal Cognitive Assessment - test)
Time frame: 12 months
Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on otolaryngological status in hearing functions
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)
Time frame: 12 months
Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on otolaryngological status in labyrinth functions
Composite endpoint including: - changes in labyrinth functions (assesed by the Skarzynski Tinnitus Scale)
Time frame: 12 months
Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on MACEs after surgery
Composite endpoint including: - occurence of stroke/TIA or death
Time frame: 12 months
Repeatability the diagnostic possibilities of non-invasive tests (Doppler ultrasound) in invasive pressure gradient values
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)
Time frame: 12 months
Repeatability the diagnostic possibilities of non-invasive tests (CT angiogram) in invasive pressure gradient values
Composite endpoint including: - comparison of the obtained invasive pressure gradient values with angio-CT: degree of stenosis
Time frame: 12 months
Repeatability the diagnostic possibilities of non-invasive tests ("CT-FFR") in invasive pressure gradient values
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)
Time frame: 12 months
Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (1)
Composite endpoint including: - occurrence of periprocedural neurological event: TIA, stroke, death in patients who underwent CAS with the invasive intravascular pressure measurement procedure
Time frame: 12 months
Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (2)
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
Time frame: 12 months
Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (3)
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
Time frame: 12 months
Incidence of Treatment-Related Adverse Events [safety and tolerability] associated with the invasive intravascular pressure measurement procedure (4)
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
Time frame: 12 months
Algorithm angio-CT/non invasive pressure measurement in carotid
Creation a multiple regression model based on the data from non-invasive pre-procedural measurements on the incidence of unfavourable outcome measures.
Time frame: 48 months
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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4th Military Clinical Hospital with Polyclinic, Poland