Intracranial Atherosclerotic Stenosis
Conditions
Interventions
Medical treatment group:intensive medical management and aspirin therapy
Endovascular therapy group:endovascular angioplasty/stenting procedure
Operating group:Encephalo-Duro-Arterio-Synangiosis
Sponsors
the First Medical Centre, Chinese PLA General Hospital, Beijing 100853, China.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. TIA or non-disabling ischemic stroke (occurred within 30 days prior to hospital admission). 2. Atherosclerotic stenosis or occlusion of ICA or MCA (ranging from 70% to 100%). 3. Eligible qualifying events: ischemic stroke events that meet enrollment criteria despite the application of multiple medical management approaches, including at least one antiplatelet drug therapy. 4. mRS (modified Rankin Scale) score = 140/90 mmHg or requiring antihypertensive treatment; - Dyslipidemia (LDL > 130 mg/dl or HDL 150 mg/dl or receiving lipid-lowering therapy); - Smoking; - Non-insulin-dependent diabetes mellitus or insulin-dependent diabetes mellitus lasting for less than 15 years; - Family history of any of the following: myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention or stenting, stroke, carotid endarterectomy (CEA) or internal carotid artery stenting, with parents or siblings undergoing vascular surgery at ages < 55 years for males and < 65 years for females at the time of the stroke event. (3) History of any of the following diseases: myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention or stenting, CEA or internal carotid artery stenting, atherosclerotic peripheral vascular disease, etc. (4) Extracranial carotid or vertebral artery, contralateral internal carotid artery, subclavian artery, coronary artery, iliac artery, femoral artery, other lower or upper extremity arteries, mesenteric artery, or renal artery stenosis found through noninvasive vascular imaging or angiography, considered to be due to atherosclerosis. (5) Noninvasive vascular imaging indicating the presence of aortic arch atherosclerosis. (6) Any atherosclerotic large artery disease indicated by noninvasive vascular imaging or angiography. 6. Menstrual history within the past 18 months, and a negative pregnancy test. 7. Patient's voluntary agreement to follow up according to the study protocol. 8. Patient is contactable by telephone. 9. Evidence from MRI or angiography indicating poor collateral circulation (ASITN/SIT grade 0-2) and the presence of hypoperfusion.
Exclusion criteria
Exclusion criteria: 1. Extracranial tandem lesions (stenosis 70%-99% or occlusion). 2. Intracranial vertebral artery or basilar artery stenosis (70%-99%). 3. Anticipated angioplasty (stenting or CEA) on extracranial (carotid or vertebral) or intracranial arteries within 30 days prior to enrollment. 4. Previous stenting, angioplasty, or other device implantation on the target vessel, or plans for angioplasty or stenting on the target lesion. 5. Planned simultaneous angioplasty or stenting at intracranial stenosis sites. 6. Intraluminal thrombus present at or near the lesion site. 7. Aneurysm present at, around, or distal to the intracranial stenosis lesion. 8. Any intracranial tumor (except meningioma) or intracranial vascular malformation. 9. Calcification near the eligible artery indicated by CT or angiography. 10. Patient has received thrombolytic therapy within 24 hours. 11. Neurological deficit progression occurs within 24 hours after enrollment. 12. Large cerebral infarction (diameter > 5 cm) with a risk of hemorrhagic transformation within 30 days prior to enrollment. 13. Any hemorrhagic infarction within 14 days prior to enrollment. 14. Hemorrhagic cerebral infarction related to edema effect within 15-30 days prior to enrollment. 15. History of any primary intracranial hemorrhage. 16. Any intracranial hemorrhage (subarachnoid hemorrhage, subdural hemorrhage, epidural hemorrhage) within 30 days prior to enrollment. 17. Any untreated chronic subdural hematoma (thickness > 5 mm). 18. Intracranial vascular stenosis not caused by atherosclerosis: intracranial vascular stenosis due to artery dissection; moyamoya disease; any consistent vasculitic lesions; herpes zoster, varicella zoster, or other viral vasculopathies; neurosyphilis; intracranial infection or cerebrospinal fluid pleocytosis-induced vascular stenosis; radiation-induced vascular stenosis; fibromuscular dysplasia; sickle cell anemia; neurofibromatosis; central nervous system invasive leukemia; postpartum vasculopathy; suspected post-thrombolysis embolism, etc. 19. Presence of conditions that may cause cerebrovascular occlusion due to cardioembolic sources: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac vegetations, myocardial infarction within 3 months, dilated cardiomyopathy, spontaneous echo contrast in the left atrium, ejection fraction 1.5; (6) Abnormal coagulation factors; (7) Alcoholism; (8) Drug abuse; (9) Uncontrolled severe hypertension: systolic blood pressure >= 180 mmHg, diastolic blood pressure >= 115 mmHg; (10) Severe liver injury; (11) Severe renal injury. 23. Major surgery within 30 days before enrollment or planned within 90 days after enrollment. 24. Exceeding the indications for warfarin or heparin use. Note: subcutaneous heparin use for deep venous thrombosis prophylaxis during hospitalization is allowed. 25. Presence of severe neurological defects that prevent the patient from living independently. 26. Dementia or other psychiatric disorders that prevent proper outpatient follow-up. 27. Presence of comorbid conditions with a life expectancy of less than 3 years. 28.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| stroke/death;Within one year, the CTA sequence showed a significant increase in stenosis severity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Any stroke/death;Myocardial infarction;Non-apoplectic bleeding (subdural or epidural blood);Cognitive function evaluation mRS;Asymptomatic cerebral hemorrhage;Decreased cerebral perfusion; | — |
Countries
China
Contacts
Public ContactJiayu Liu
Department of Neurosurgery, the First Medical Centre, Chinese PLA General Hospital, Beijing 100853, China.
Outcome results
None listed