Acute ischemic stroke
Conditions
Interventions
Experimental group of Phase 1:Ultrasound-mediated microbubble cavitation as a bridge to endovascular treatment
Control group of Phase 1:Endovascular therapy
Experimental group 1 of Phase 2:Ultrasound-mediated microbubble cavitation as a bridge to endovascular treatment
Experimental group 2 of Phase 2:Ultrasound-mediated microbubble cavitation as a bridge to endovascular treatment
Control group of Phase 2:Endovascular therapy
Sponsors
The Second Affiliated Hospital , Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Phase One: 1. Age >= 18 years old; 2. Within 24 hours of onset; 3. Diagnosed as acute ischemic stroke based on clinical symptoms or imaging examinations; 4. NIHSS score >= 5 points. 5. Confirmed as large vessel occlusive stroke by CTA/MRA/DSA (definition of large vessels: ICA, V1-V4 segments of vertebral artery (VA), basilar artery (BA), P1 segment of posterior cerebral artery (PCA), A1 segment of anterior cerebral artery (ACA), M1 and M2 segments of middle cerebral artery (MCA)); 6. Treated with intravenous thrombolytic drugs or antiplatelet drugs; 7. The patient or the family member signed a written informed consent form. Second stage: 1. 18 years = 1.8, and ischemic penumbra volume >= 15 ml) 4. Diagnosed as acute ischemic stroke based on clinical symptoms and imaging examinations 5. Confirmed as acute large vessel occlusion by CTA/DSA 6. 6 points <= NIHSS score <= 25 points 7. The patient or the family member signed a written informed consent form
Exclusion criteria
Exclusion criteria: Phase 1: 1. mRS Score >=2 before onset; 2. Pregnant or lactating women; 3. Intracranial hemorrhage or previous history of cerebral hemorrhage confirmed by CT or MRI; 4. Patients who are allergic to ultrasound microbubbles, clopidogrel, aspirin, alteplase, or have contraindications to the use of the above drugs; 5. Systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg, and can not be controlled by oral antihypertensive drugs; 6. Genetic or acquired bleeding constitution, anticoagulant factor deficiency; Oral anticoagulants and INR>1.7; 7. Random blood glucose 22.2mmol/L (400mg/dl), platelet 3 times the upper limit of normal or AST > 3 times the upper limit of normal; Patients with chronic hemodialysis and severe renal insufficiency (glomerular filtration rate 220µmol/L (2.5mg/dl)); 10. Macrovascular disease not caused by atherosclerotic lesions, including: "Arterial dissection, Moya-moya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular disease, neurosyphilis, any other intracranial infection, any vascular stenosis associated with pleocytosis in the cerebrospinal fluid, radiation induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign vascular disease of the central nervous system, birth. Posterior vascular disease, suspected vasospasm, suspected embolus recanalization; 11. Cardiogenic stroke or potential cardiogenic thrombosis, the presence of any of the following definite causes of cardiogenic embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, left atrial spontaneous acoustic contrast; 12. History of parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage within the last 30 days; Myocardial infarction within the past 30 days; 13. 14. Major surgery (including open femoral, aortic, carotid, subclavian or intracranial artery bypass surgery, etc.) and cerebral angioplasty (balloon or stent implantation) are planned within 90 days; 15. Heart, lung and other important organ dysfunction; 16. Current severe alcohol dependence or drug abuse; 17. Dementia or mental illness interferes with patients' ability to adhere to the follow-up schedule reliably; 18. Life expectancy less than 6 months due to advanced disease; 19. Expected inability to complete the follow-up; 20. Intracranial aneurysms, arteriovenous malformations; 21. Brain tumors with mass effect on imaging. 22. Is participating in other clinical trials. Phase 2: 1. Age >80 years old, or 1 before onset; 3. Pregnant or lactating women; 4. The patient's craniocerebral acoustic window condition was poor, and ultrasound treatment could not be performed; 5. Cerebral hemorrhage was confirmed by head imaging examination such as CT or MRI; 6. Allergy or contraindications to microbubbles or antiplatelet drugs such as clopidogrel, aspirin, tirofiban; 7.INR>1.7; 8. Genetic or acquired bleeding constitution, deficiency of anticoagulant factors, or history of cerebral parenchymal or subarachnoid, subdural or extradural bleeding within the past 30 days with oral an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90 day mRS score 0-2 points (%);Incidence of symptomatic intracranial hemorrhage;Mortality at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90 day mRS score 0-1 points (%);90 day mRS score shift analysis;Changes in NIHSS score 24hours and 5-7 days;90 day EQ-5D-5L scale rating;90 day Bathel rating; | — |
Countries
China
Contacts
Public ContactQingwu Yang
The Second Affiliated Hospital , Army Medical University
Outcome results
None listed