Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

Not Applicable

Completed

• Conditions: Stroke; Carotid Stenosis; Ischemic Attack; Carotid Atherosclerosis; Bleeding
• Interventions: Procedure: Transfemoral carotid artery stenting; Procedure: Transradial carotid artery stenting

• Registration Number: NCT02722720
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-03-13
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-30
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carotid stenting, Transfemoral approach	Transfemoral carotid artery stenting	Internal carotid artery stenting using transfemoral arterial approach
Carotid stenting, Transradial approach	Transradial carotid artery stenting	Internal carotid artery stenting using transradial arterial approach

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Neurocognitive disorders	before and 30 days after carotid artery stenting	Weschler Test of Adult Reading (WTAR)
Device success	intraoperative	Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.
Lesion success	intraoperative	Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any percutaneous coronary intervention (PCI) approach.
Cerebral embolism	intraoperative	Amount of intraoperative microembolic signals revealed by transcranial ultrasound Doppler examination.
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.
Operative access complications	intraoperative/ 1 day after operation	Bleeding, aneurisms, large hematomas, atrioventricular fistula
Fluoroscopic time	intraoperative
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.

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology; 🇷🇺 Novosibirsk, Russian Federation