Bleeding, Carotid Atherosclerosis, Carotid Stenosis, Ischemic Attack, Stroke
Conditions
Keywords
Carotid atherosclerosis, Carotid stenosis, Ischemic attack, Stroke, Carotid stenting, Transradial approach, Transfemoral approach, Bleeding, Thromboembolism, Embolism, Neurocognitive disorders
Brief summary
The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting.
Detailed description
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.
Interventions
PROCEDURETransradial carotid artery stenting
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 A guidewire is advanced through its lumen, and the trocar is withdrawn.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.
PROCEDURETransfemoral carotid artery stenting
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 A guidewire is advanced through its lumen, and the trocar is withdrawn.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.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic patients with internal carotid artery stenosis(\>50%) * Asymptomatic patients with internal carotid artery stenosis(\>60%) * Anatomy of internal carotid artery applicable for stent implantation and use of embolic protection device
Exclusion criteria
* Stroke, myocardial infarction or underwent operative treatment within 1 month * Prior carotid artery stenting * Cerebral vessels aneurisms/ malformations * Subclavian artery/ brachiocephalic trunk stenosis * Contraindications for antiplatelet or/and anticoagulation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral embolism | during 24 hours after carotid artery stenting | Amount of intraoperative micro- and macroembolic complications evaluated as an occurence of new ipsilateral ischemic lesions estimated due to brain MRI data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACCE | during 30 days after carotid artery stenting | 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. |
| Neurocognitive disorders | before and 30 days after carotid artery stenting | Mini-Mental State Examination (MMSE) |
| Device success | intraoperative | Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure. |
| Cerebral embolism | intraoperative | Amount of intraoperative microembolic signals revealed by transcranial ultrasound Doppler examination. |
| In-hospital procedure success | Within 5-day hospitalization | 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. |
| Operative access complications | intraoperative/ 1 day after operation | Bleeding, aneurisms, large hematomas, atrioventricular fistula |
| Fluoroscopic time | intraoperative | — |
| Lesion success | intraoperative | Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any percutaneous coronary intervention (PCI) approach. |
Countries
Russia
Outcome results
None listed