The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting.
The use of transradial approach in carotid arteries stenting can significantly decrease the amount of adverse events associated with transfemoral approach such as bleeding or hematoma. Otherwise providing transradial approach is fraught with technical difficulties of common carotid artery canulation that can result in embolic complications. Taking into account the absence of studies in this area of medicine, providing investigation evaluating parameters of safety for both methodics is very actual.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The radial artery is punctured with a trocar. A guidewire is advanced through its lumen, and the trocar is withdrawn. An introducer is passed into the vessel. Then a standard endovascular procedure is carried out under local anesthesia and fluoroscopic control. To prevent cerebral embolism, a protection device is positioned distally of target lesion in internal carotid artery. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control stent is implanted. After removing all of devices a control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix (clopidogrel) in dose 300-600 mg prescription before the procedure and heparin sodium injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and Plavix (clopidogrel) in dose 75/d should be prescribed within 2 months.
The common femoral artery is punctured with a trocar. A guidewire is advanced through its lumen, and the trocar is withdrawn. An introducer is passed into the vessel. Then a standard endovascular procedure is carried out under local anesthesia and fluoroscopic control. To prevent cerebral embolism, a protection device is positioned distally of target lesion in internal carotid artery. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control stent is implanted. After removing all of devices a control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix (clopidogrel) in dose 300-600 mg prescription before the procedure and heparin sodium injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and Plavix (clopidogrel) in dose 75/d should be prescribed within 2 months.
State Research Institute of CIrculation Pathology
Novosibirsk, Russia
Cerebral embolism
Amount of intraoperative micro- and macroembolic complications evaluated as an occurence of new ipsilateral ischemic lesions estimated due to brain MRI data.
Time frame: during 24 hours after carotid artery stenting
Cerebral embolism
Amount of intraoperative microembolic signals revealed by transcranial ultrasound Doppler examination.
Time frame: intraoperative
MACCE
Major adverse cardiac and cerebrovascular events (MACCE) including: including: All-cause mortality, Myocardial infarction, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization.
Time frame: during 30 days after carotid artery stenting
Neurocognitive disorders
Mini-Mental State Examination (MMSE)
Time frame: before and 30 days after carotid artery stenting
Neurocognitive disorders
Rey Auditory Verbal Learning Test (RALVT)
Time frame: before and 30 days after carotid artery stenting
Neurocognitive disorders
Grooved Pegboard test
Time frame: before and 30 days after carotid artery stenting
Neurocognitive disorders
Boston Naming Test
Time frame: before and 30 days after carotid artery stenting
Neurocognitive disorders
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Geriatric Depression Scale
Time frame: before and 30 days after carotid artery stenting
Neurocognitive disorders
Weschler Test of Adult Reading (WTAR)
Time frame: before and 30 days after carotid artery stenting
Device success
Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.
Time frame: intraoperative
Lesion success
Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any percutaneous coronary intervention (PCI) approach.
Time frame: intraoperative
In-hospital procedure success
Procedure success is defined as achievement of a final residual diameter stenosis 20% together with the absence of any in-hospital major adverse cardiac event.
Time frame: Within 5-day hospitalization
Operative access complications
Bleeding, aneurisms, large hematomas, atrioventricular fistula
Time frame: intraoperative/ 1 day after operation
Fluoroscopic time
Time frame: intraoperative