Innovative Application of Pressure Gradient Measurement in Internal Carotid Stenosis in Patients Undergoing CAS
NCT ID: NCT06123767
Last Updated: 2024-03-07
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2024-04-01
2027-07-31
Brief Summary
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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.
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Detailed Description
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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:
* Doppler ultrasound of the extracranial cephalic arteries
* initial qualification for CAS /neurologist, vascular surgeon/
* informed consent to participate in the study
* cardiological consultation (modification of risk factors)
* angio-CT of the neck and head
* assessment of the cerebral perfusion alterations using DSC (dynamic susceptibility contrast) MR perfusion
* additional neurological (with questionnaires), psychological (with questionnaires) and otolaryngological examination
* surgery (CAS) - Department of Vascular Surgery, Department of Cardiology
Measurements (invasive pressure) taken during the procedure before angioplasty (after insertion of the neuroprotection into the internal carotid artery) and after stent implantation:
* placement of a micro catheter to measure invasive pressure
* taking a measurement in the internal carotid artery above the stenosis (in the normal section of this artery)
* performing a measurement before the stenosis (in the normal segment of the common carotid artery at the level of the exit of the external carotid artery)
* 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 of about 1mm in size (i.e., more than 2 times smaller than the delivery system for distal protection, which is the standard procedure, so the risk of complications is minimal). In the study protocol, the insertion of the catheter and measurement of pressures will be followed by the placement of a neuroprotection device in the distal carotid artery (standard of practice) to avoid possible complications.
Evaluation during treatment:
* angio-CT of the neck and head, 3 month after CAS
* assessment of the cerebral perfusion alterations using DSC (dynamic susceptibility contrast) MR perfusion, 3 month after CAS
* Doppler ultrasound of the extracranial cephalic arteries, 3 and 12 month after CAS
* Neurological (with questionnaires), psychological (with questionnaires) and otolaryngological examination betwenn 10-16 week after CAS
* Cardiological evaluation at 3, 6, 12 month after CAS (modification of risk factors)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Staff involved in the CAS procedure (with or without blood pressure measurement) will not participate in further patient care and will not provide information to other researchers and people conducting therapy and diagnostics.
Study Groups
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CAS + Intravascular measuring the pressure gradient
Patients with internal carotid stenosis qualified for angioplasty with stent implantation.
Standard CAS procedure with additional intravascular pressure measurements
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
CAS (standard)
Patients with internal carotid stenosis qualified for angioplasty with stent implantation.
Standard CAS 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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Medical Research Agency, Poland
OTHER_GOV
4th Military Clinical Hospital with Polyclinic, Poland
OTHER
Responsible Party
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Krzysztof Ściborski
Vice-Head of Cath Lab; Department of Cardiology, Center for Heart Disease, 4th Military Hospital, Wrocław, Poland
Principal Investigators
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Krzysztof Ściborski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
4th Military Hospital in Wrocław
Waldemar Banasiak, MD, PhD
Role: STUDY_DIRECTOR
4th Military Hospital in Wrocław
Artur Telichowski, MD, PhD
Role: STUDY_DIRECTOR
4th Military Clinical Hospital with Polyclinic, Poland
Adrian Doroszko, MD, PhD
Role: STUDY_DIRECTOR
4th Military Clinical Hospital with Polyclinic, Poland
Locations
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4th Military Hospital
Wroclaw, Lower Silesian Voivodeship, Poland
Countries
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Central Contacts
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References
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Other Identifiers
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ABM/2023/01/00001
Identifier Type: -
Identifier Source: org_study_id
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