carotid stenosis
Conditions
Interventions
case series:Nil
Sponsors
Xuanwu Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years (including 80 years old), gender is not limited; 2. Brain CT or MRI excludes large-area cerebral infarction (infarction > 1/2 of the middle cerebral artery blood supply area); 3. Diagnosed with extracranial carotid artery stenosis (including common carotid stenosis and internal carotid artery stenosis) by whole cerebral angiography (DSA), suitable for carotid stent intervention, and meet one of the following conditions: (1) Has had an ischemic cerebrovascular disease attack related to stenosis in the past 6 months, including ipsilateral hemisphere nondisabling ischemic stroke, TIA symptoms, or amaurosis transient, with stenosis >=50% confirmed by angiography; (2) Asymptomatic patients with internal carotid artery stenosis of 70%-99% (NASCET criteria 11); 4. It is necessary and suitable to use a domestic distal thrombus protection device to reduce the risk of thromboembolism; 5. mRS score 0-2; 6. Subject willing and following protocol requirements and data collection procedures; 7. Subjects understood and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Multiple severe stenoses or occlusions in the proximal or distal vessels of the lesion; high degree of long-segment calcification in the lesion; severe distortion of the target vessel or anatomical factors that make the guide catheter, vascular sheath or stent difficult to place; 2. The lesion site is asymptomatic chronic complete occlusion of the carotid artery, and there are a large number of acute or subacute thrombi in the vicinity of the lesion; 3. In addition to the target carotid artery, there are other cerebral arteries that require simultaneous intervention, such as vertebral artery, basilar artery, middle cerebral artery, subclavian artery, intracranial segment of internal carotid artery or innominate artery; 4. Progressive stroke, bradycardia (1.5, increased risk of bleeding with abnormal coagulation mechanisms, severe uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure >115mmHg), severe liver damage (AST or ALT more than 3 times normal, cirrhosis, etc.) and severe renal impairment (creatinine > 3mg/dL, i.e. > 265.2µmol/L, except for dialysis); serious dysfunction of important organs such as heart, lung, liver and kidney; 10. Those with poor functional status (mRS score 3-5 points) or severe mental illness before the onset; 11. Patients with dementia or mental disorders cannot be followed up in outpatient clinics; 12. Combined with other diseases, the life expectancy is less than 1 year; 13. Pregnancy or perinatal period; 14. The patients participated in other interventional clinical trials, and their interventions had a significant impact on this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any composite of stroke (hemorrhagic or ischemic), myocardial infarction, and/or death; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ipsilateral ischemic stroke incidence;Changes in neurological function evaluation before and 30 days after surgery;Surgical success rate; | — |
Countries
China
Contacts
Public ContactGao Peng
Xuanwu Hospital of Capital Medical University
Outcome results
None listed