Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

Study Overview
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Brief Summary
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The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting.

Detailed Description
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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.

Official Title
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Prospective, Randomized, Single Center Study of Atherothrombotic and Thromboembolic Events After Carotid Artery Stenting Using Transfemoral and Transradial Approach

Conditions
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Carotid Atherosclerosis, Carotid Stenosis, Ischemic Attack, Stroke, Bleeding

Intervention / Treatment
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* Procedure: Transradial carotid artery stenting
* Procedure: Transfemoral carotid artery stenting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carotid stenting, Transradial approach<br>Internal carotid artery stenting using transradial arterial approach | Procedure: Transradial carotid artery stenting<br>* 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.<br>|
| Active Comparator: Carotid stenting, Transfemoral approach<br>Internal carotid artery stenting using transfemoral arterial approach | Procedure: Transfemoral carotid artery stenting<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral embolism | Amount of intraoperative micro- and macroembolic complications evaluated as an occurence of new ipsilateral ischemic lesions estimated due to brain MRI data. | during 24 hours after carotid artery stenting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral embolism | Amount of intraoperative microembolic signals revealed by transcranial ultrasound Doppler examination. | 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. | during 30 days after carotid artery stenting | 
| Neurocognitive disorders | Mini-Mental State Examination (MMSE) | before and 30 days after carotid artery stenting | 
| Neurocognitive disorders | Rey Auditory Verbal Learning Test (RALVT) | before and 30 days after carotid artery stenting | 
| Neurocognitive disorders | Grooved Pegboard test | before and 30 days after carotid artery stenting | 
| Neurocognitive disorders | Boston Naming Test | before and 30 days after carotid artery stenting | 
| Neurocognitive disorders | Geriatric Depression Scale | before and 30 days after carotid artery stenting | 
| Neurocognitive disorders | Weschler Test of Adult Reading (WTAR) | 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. | intraoperative | 
| Lesion success | Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any percutaneous coronary intervention (PCI) approach. | 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. | Within 5-day hospitalization | 
| Operative access complications | Bleeding, aneurisms, large hematomas, atrioventricular fistula | intraoperative/ 1 day after operation | 
| Fluoroscopic time |  | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid atherosclerosis, Carotid stenosis, Ischemic attack, Stroke, Carotid stenting, Transradial approach, Transfemoral approach, Bleeding, Thromboembolism, Embolism, Neurocognitive disorders