A single center, prospective, outcome-assessor-blinded, randomized controlled trial study (CASH-ES) is designed to compare the efficiency of two different distal embolism protection devices (SpiderFX and Emboshield NAV6) in during CAS procedure of patients with vulnerable plaque.
CAS is an alternative to CEA for treating carotid stenosis with a similar efficacy in preventing future stroke. High-intensity signal in the plaque on the TOF-MRA is associated to a high risk of cerebral embolism during stenting. The evidence of protection selection in such patients was limited. A single center, prospective, outcome- assessor-blinded, randomized controlled trial study (CASH-ES) is designed to compare the efficiency of two distal embolism protection devices (SpiderFX and Emboshield NAV6) during CAS procedure of patients with vulnerable plaque. Asymptomatic patients with internal carotid artery stenosis ≥ 70% (NASCET) and symptomatic patients with a stenosis ≥ 50% who is over 70 years old, diagnostic of vulnerable plaque on ultrasound or have a high-intensity signal in the relevant plaques on TOF-MRA will be included. Patients are randomized in two balanced groups (1:1) to receive CAS with either distal (Spider FX) or distal (Emboshield NAV6) protection. The primary endpoint is the incidence of new cerebral ipsilateral ischemic lesions on the DW-MRI within 7-days post operation. Secondary endpoints include the number, size, location of new cerebral ischemic lesions on the DW-MRI, the counts of MES during TCCD monitoring during procedure, procedural complications, stroke, myocardial infarction, and death within 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
172
a distall occlusion Emboshield NAV6 will be used as the embolism protection device during CAS
a distal SpiderFX will be used as the embolism protection device during CAS
Xuanwu Hospital
Beijing, China
Ipsilateral new ischemic lesions on DWI
The incidence of ipsilateral new ischemic lesions on DWI after CAS
Time frame: Within 7 days post-operation
major stroke
the incidence of major stroke after CAS, defined as new onset of neurological symptoms causing an increase of NIHSS ≥ 4 or worsening of existing focal neurological deficit lasting ≥ 24 hours
Time frame: within 7 days post-operation
myocardial infarction
the incidence of myocardial infarction after CAS, defined as new onset of chest discomfort or cardiac stroke or heart failure with a rise and/or fall of cardiac biomarkers and ECG abnormalities
Time frame: within 7 days post-operation
death
In-hospital mortality
Time frame: within 7 days post-operation
Any hemorrhage, acute kidney injury and other procedure-related complications
including major/minor hemorrhage, acute kidney injury, etc.
Time frame: within 7 days post-operation
The number of new cerebral ischemic lesions on DW-MRI
The number of new cerebral ischemic lesions on DW-MRI
Time frame: within 7 days post-operation
The size of new cerebral ischemic lesions on DW-MRI
The size of new cerebral ischemic lesions on DW-MRI
Time frame: within 7 days post-operation
The location of new cerebral ischemic lesions on DW-MRI
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The location of new cerebral ischemic lesions on DW-MRI
Time frame: within 7 days post-operation
MES counting during CAS
TCD monitoring of MES counting during CAS
Time frame: during CAS procedure