This is a multicenter, open, randomized controlled trial to evaluate the efficacy and safety of carotid artery stenting/carotid endarterectomy versus best medical treatment for asymptomatic carotid artery stenosis in Chinese population.
This is a multicenter, open, randomized controlled trial to evaluate the efficacy and safety of carotid artery stenting/carotid endarterectomy versus best medical treatment for asymptomatic carotid artery stenosis in Chinese population. The study will be conducted at 11 centers and is expected to enroll 1056 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,056
Carotid Artery Stenting/Carotid Endarterectomy
Aspirin 100mg/ day plus clopidogrel 75mg/ day for the first three months after enrollment or revascularization, aspirin 100mg/ day after three months, and the statin dose was adjusted according to blood lipids levels. Best medical treatment also includes risk factor control: good lifestyle, smoking cessation, weight control, regular exercise, SBP \< 140 mmHg, HDL \< 70 mg/dl (1.8mmol/L), and glycemic control. Patients with poor control of risk factors were dynamically adjusted during follow-up. In addition, patients undergoing CAS received dual antiplatelet therapy for at least 3 to 5 days before surgery, and patients undergoing CEA also received a preoperative oral antiplatelet drug (aspirin 100mg/ day, or clopidogrel 75mg/ day) for at least 3 days after enrollment.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGXuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.
Composite of any periprocedural stroke (ipsilateral or contralateral; major or minor), myocardial infarction, or death during1 month peri-procedural period, and postprocedural ipsilateral stroke 1 to 12-months.
Time frame: 0 to 12 months
Technical success rate
Technical success was defined as final residual stenosis less than 30%, TIMI grade 3, and no dissection or thrombus after any endovascular treatment.
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 death
Incidence of death at 30 days follow up.
Time frame: 30 days
Carotid restenosis rate
Carotid restenosis was defined as restenosis ≥50% after carotid revascularization, that is, peak systolic velocity ratio (PSVR) ≥2.0 on ultrasound examination.
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGHebei General Hospital
Shijiazhuang, Hebei, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGThe Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGFirst Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGShanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITING...and 1 more locations
Time frame: 12 months
Incidence of target lesion revascularization
Target lesion revascularization (TLR) is defined as the re-percutaneous intervention or bypass grafting of the target lesion for restenosis or other complications of the target lesion. All TLR should be preclassified as clinically drived or non-clinically drived before the investigator performs angiography again.
Time frame: 12 months
Improvement in cognitive function
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 30 days follow up.
Time frame: 30 days
Improvement in cognitive function
Cognitive function was assessed by Mini-mental State Examination (MMSE) at 30 days follow up.
Time frame: 30 days
Improvement in cognitive function
Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 12 months follow up.
Time frame: 12 months
Improvement in cognitive function
Cognitive function was assessed by Mini-mental State Examination (MMSE) at 12 months follow up.
Time frame: 12 months