cerebrovascular diseases
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Army Military Medical University
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Aged 30 years or older; (2) Ischemic stroke due to occlusion of the intracranial aorta within 90 days before surgery; (3) The best preoperative medication (intensive lipid-lowering, anti-platelet therapy and risk factor control) is invalid; (4) Digital subtraction angiography (DSA) confirms that the lesion is anterior circulation and posterior circulation intracranial aortic occlusion; (5) preoperative mRS score <= 2 points; (6) TOAST classification is aortic atherosclerosis; (7) The lesion length is <= 14 mm, and the target vessel diameter is between 2.0 mm and 4.5 mm; (8) The blood perfusion of the target blood supply area is decreased, and at least one of the following conditions is required for low perfusion; 1) case of head CT perfusion imaging showed low perfusion of the diseased vessel area (CBF was reduced by 30% compared with contralateral perfusion); 2) DSA-based ASIPN/SIR collateral circulation score <3 points; 3) MRI-confirmed hemodynamic abnormal cerebral infarction (such as watershed infarction); (9) The patient signs a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Acute ischemic stroke confirmed by clinical symptoms or by head MRI in the past 1 week; (2) Stroke caused by MRI-defined simple perforator artery occlusion; (3) There is a tandem extracranial or intracranial stenosis rate > 50% or occlusion in the proximal or distal end of the target vascular occlusion segment; (4) Severe calcification of the target blood vessel; (5) The proximal or distal end of the target vessel is severely distorted, and the intracranial stent is not expected to be delivered in place; (6) There is a thrombus in the target vascular occlusion segment or its proximal end; (7) Intracranial artery stenosis/occlusion caused by non-atherosclerotic lesions, including: arterial dissection, moya-moya disease, vasculitis, herpes zoster, varicella zoster or other viral vascular disease, neurosyphilis, any other intracranial infection, any intracranial stenosis associated with cerebrospinal fluid cell growth, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, Suspected vasospasm, suspicious emboli, etc.; (8) Cardiogenic stroke or potential cardiogenic thrombosis, any of the following reasons for cardiogenic embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac thrombosis or planting Invasive, dilated cardiomyopathy, spontaneous aurora development of the left atrium; (9) Combined intracranial tumor, aneurysm or intracranial arteriovenous malformation; (10) History of stenting, angioplasty or endarterectomy for intracranial or extracranial arteries; (11) History of previous primary cerebral hemorrhage; (12) Those who received thrombolytic therapy within 24 hours prior to enrollment; (13) Neurological deterioration within 24 hours prior to enrollment (defined as: National Institutes of Health Stroke Scale (NIHSS) score increased by >= 4 points from baseline); (14) History of any brain parenchyma or other intracranial subarachnoid, subdural or epidural hemorrhage in the last 30 days; (15) myocardial infarction in the last 30 days; (16) major surgery (including open femoral artery, aortic or carotid surgery) within approximately 30 days or planned for 90 days; (17) Patients with allergies or allergies to test and surgical drugs (heparin, contrast agents, aspirin, clopidogrel, etc.) or operating devices, and contraindications for the use of these drugs; (18) The ejection fraction is 3 times normal upper limit or AST > 3 times normal upper limit; severe renal insufficiency (glomerular filtration rate 180 mmHg or diastolic blood pressure > 115 mmHg); (22) genetic or acquired hemorrhagic constitution, lack of anticoagulant factor; or anticoagulant therapy before randomization and INR > 1.5; (23) The use of warfarin or heparin exceeds the scope of the test (Note: systemic heparinization is allowed during stent implantation, and subcutaneous injection of heparin is allowed during h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptomatic stroke event, transient ischemic attack (TIA) or death;Target vascular symptomatic stroke event, transient ischemic attack (TIA) or death; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgery-related complication rate;NIHSS score;mRS score;Intra-stent stenosis rate;Stent or drug-related cardiovascular events;Compliance with medication;Brain tissue metabolism level;Non-hemorrhagic adverse event rate; | — |
Countries
China
Contacts
Public ContactQingwu Yang
The Second Affiliated Hospital of Army Military Medical University
Outcome results
None listed