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| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid Revascularization | Active Comparator | Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment |
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| Medical Treatment | Active Comparator | Best Medical Treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid Revascularization | Procedure | Carotid Artery Stenting/Carotid Endarterectomy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Rate of complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongquan Gu, Dr. | Contact | +8615901598209 | gu15901598209@aliyun.com | |
| Xixiang Gao, Dr. | Contact | +8613581674309 | vascsurgeon@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongquan Gu, Dr. | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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| Changhai Hospital |
| OTHER |
| Peking Union Medical College Hospital | OTHER |
| Hebei General Hospital | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| People's Hospital of Xinjiang Uygur Autonomous Region | OTHER |
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| Medical Treatment | Drug | 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. |
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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.
| 30 days |
| Incidence of myocardial infarction | Incidence of myocardial infarction at 30 days follow up. | 30 days |
| Incidence of ipsilateral stroke | Incidence of ipsilateral stroke at 30 days follow up. | 30 days |
| Incidence of death | Incidence of death at 30 days follow up. | 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. | 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. | 12 months |
| Improvement in cognitive function | Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 30 days follow up. | 30 days |
| Improvement in cognitive function | Cognitive function was assessed by Mini-mental State Examination (MMSE) at 30 days follow up. | 30 days |
| Improvement in cognitive function | Cognitive function was assessed by Montreal Cognitive Assessment Scale (MoCA) at 12 months follow up. | 12 months |
| Improvement in cognitive function | Cognitive function was assessed by Mini-mental State Examination (MMSE) at 12 months follow up. | 12 months |
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100192 | China |
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| The Second Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Hebei General Hospital | Recruiting | Shijiazhuang | Hebei | 050057 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
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| The Fifth Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| First Affiliated Hospital Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| Shanghai Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| People's Hospital of Xinjiang Uygur Autonomous Region | Recruiting | Ürümqi | Xinjiang | 830011 | China |
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