Endarterectomy vs Stenting Asymptomatic Carotid stenosis patients to verify the efficacy and safety.
Endarterectomy vs Stenting Asymptomatic Carotid stenosis patients to verify the efficacy and safety.Study Design is a prospective, multiple center, randomized controlled trail.600 cases enrollment predict,each group including carotid artery stenting and carotid endarterectomy 300 cases.Follow-up period of 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Carotid Artery Stenting
Carotid Endarterectomy
Sino-Japanese Friendship Hospital
Beijing, China
NOT_YET_RECRUITINGShanghai Changhai Hospital
Shanghai, China
RECRUITINGShanghai ChangZheng Hospital
Shanghai, China
Incidence of composite endpoints of myocardial infarction, stroke, and any death
Incidence of composite endpoints of myocardial infarction, stroke, and any death at 30 days follow up
Time frame: 30 days
Surgery success rate
Surgery success rate
Time frame: 1 day
Rate of complications
Rate of complications within 30 days, complications include:Cranial nerve and peripheral nerve injury, vascular injury, non cerebral hemorrhage, wound complications as neck incision or related to puncture site, and other (such as anesthesia) complications;
Time frame: 30 days
Incidence of myocardial infarction
Incidence of myocardial infarction at 30 days follow up;
Time frame: 30 days
Incidence of Ipsilateral stroke
Incidence of Ipsilateral stroke at 30 days follow up;
Time frame: 30 days
Incidence of Bilateral stroke
Incidence of Bilateral stroke at 30 days follow up;
Time frame: 30 days
Incidence of ipsilateral stroke
Incidence of ipsilateral stroke at 12 months follow up;
Time frame: 12 months
Carotid restenosis rate
Carotid restenosis rate at 12、24 months follow up;
Time frame: 12、24 months
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Zhongshan Hospital affiliated to Fudan University
Shanghai, China
RECRUITINGThe first affiliated Hospital of Xi ' an Jiaotong University
Xi'an, China
RECRUITINGThe first affiliated Hospital of Zhengzhou University
Zhengzhou, China
RECRUITINGIncidence of target lesion revascularization
Incidence of target lesion revascularization at 6、12、24 months follow up;
Time frame: 6、12、24 months
Incidence of composite endpoints of myocardial infarction, stroke, and any death
Incidence of composite endpoints of myocardial infarction, stroke, and any death at 6、12、24 months follow up;
Time frame: 6、12、24 months
Incidence of major stroke and minor stroke
Incidence of major stroke and minor stroke at 6、12、24 months follow up;
Time frame: 6、12、24 months
Surgical time
Surgical time
Time frame: Through hospital stay,an average of 10days
Hospitalization days
Hospitalization days
Time frame: Through hospital stay,an average of 10days
Hospitalization fees
Hospitalization fees
Time frame: Through hospital stay,an average of 10days