Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital of Soochow University | OTHER |
| The First Hospital of Jilin University | OTHER |
| The First Affiliated Hospital of Shanxi Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this multiple-center study are: 1) To establish the ultrasound criteria for evaluating vulnerable plaques by comparing the plaque echo characteristics before CEA (carotid artery endarterectomy) and plaque specimen after CEA.
2) To establish the carotid artery recanalization strategies based on the evaluation results of carotid artery and intracranial artery by color doppler flow imaging and TCCS/TCD (transcranial color coded sonography/transcranial doppler).
3) To compare the success rate and the incidence of restenosis between CEA and carotid artery stenting.
In this study, a total of 1000-1200 patients with carotid artery moderate (50-69%, with symptoms), severe (70-99%) stenosis (with or without symptoms) or occlusion who received either CEA or stenting are to recruited. Before carotid artery recanalization, CDFI (color duplex flow imaging) and TCCS/TCD are used to evaluate the structures and hemodynamic of carotid artery and intracranial artery. In addition, patients are to be followed up by ultrasound 1 week, 3 month, 6month and 1 year after recanalization.
1) The general information of enrolled subjects, which include age, gender, resident address and telephone number, the history of hypertension, coronary artery diseases, dyslipidemia, diabetes mellitus and smoking.
2. The primary endpoints are: The combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, residual sternosis≥50% within 30-day after recanalization. The secondary endpoints are the re-current cerebral artery events and the occurence of restenosis during the at least 1 year follow-up period.
4. Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0) software are used for statistical analysis.
1) Diagnostic test are used to test the sensitivity, specificity and accuracy of ultrasound for evaluating vulnerable plaque by using plaque specimen after CEA as the "gold" standard.
2) The Chi-square test are used to compare the success rate of stenting and CEA. The Cox regression analysis are used to compare the restenosis rate of stenting and CEA.
3) A P<0.05 was considered statistically significance. 5. Quality assurance plan:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid artery recanalization CEA or carotid artery stenting | Procedure | Carotid artery recanalization CEA or carotid artery stenting |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of combination endpoints events including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome,and residual sternosis≥50%. | The rate of combination endpoints events, including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, and residual sternosis≥50% | within 30-day after recanalization. |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of re-current cerebral artery events and the occurence of restenosis | the rate of re-current cerebral artery events and the occurence of restenosis | during the at least 1 year follow-up period |
Not provided
Inclusion Criteria:
1) Patients with carotid artery moderate (50-69%, with symptoms), severe (70-99%, with or without symptoms) stenosis or occlusion diagnosed by CDFI and confirmed by CTA or DSA.
2) Patient has the indications for carotid artery stenting or CEA according to the guidelines published by the Stroke Prevention Engineering Committee, the National Health Commission of China.
3) Patient with complete imaging evaluation and can be followed up to at least 1 year.
Exclusion Criteria:
- 1) Patients with non-atherosclerotic carotid artery stenosis or occlusion, such as dissection, aneurysm, arteritis, cardiac embolism and et al.
2) Patients with cerebral hemorrhage. 3) Pregnant
Not provided
Not provided
Patients with carotid artery moderate (50-69%), severe (70-99%) stenosis or occlusion, who needs recanalization by CEA or stenting.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yang Hua, MD | No.45 Changchun Road, Beijing,100053, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D007511 | Ischemia |
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| The Second People's Hospital of Liaocheng |
| UNKNOWN |
| Liaocheng Brains Hospital | UNKNOWN |
| Lanzhou University Second Hospital | OTHER |
| First Hospital of China Medical University | OTHER |
| Dalian Municipal Central Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| Henan Provincial People's Hospital | OTHER |
| Shengli Oilfield Hospital | OTHER |
| Zhengzhou First People's Hospital | UNKNOWN |
| Weihai Municipal Hospital | OTHER |
Not provided
Not provided
Not provided
Carotid artery plaques removed by CEA.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002340 | Carotid Artery Diseases |
| D001157 | Arterial Occlusive Diseases |