Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Bleeding; Carotid Stenosis; Carotid Atherosclerosis; Ischemic Attack
• Intervention / Treatment: Procedure: Transradial carotid artery stenting; Procedure: Transfemoral carotid artery 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • State Research Institute of Circulation Pathology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carotid stenting, Transradial approach; Internal carotid artery stenting using transradial arterial approach	Procedure: Transradial 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.
Active Comparator: Carotid stenting, Transfemoral approach; Internal carotid artery stenting using transfemoral arterial approach	Procedure: Transfemoral 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 13, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Stroke; Embolism; Carotid stenosis; Bleeding; Thromboembolism; Carotid stenting; Transradial approach; Neurocognitive disorders; Carotid atherosclerosis; Ischemic attack; Transfemoral approach
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Hemorrhage; Carotid Stenosis; Carotid Artery Diseases; Atherosclerosis
• Other Study ID Numbers: CASTE-1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No