intracranial atherosclerotic steno-occlusive disease
Conditions
Interventions
intracranial atherosclerotic steno-occlusive disease:Surgical operation(Encephaloduroarteriosynangiosis)
Sponsors
Department of Neurosurgery, PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Referring to the SAMMPRIS trial published in the New England Journal in 2011 and the clinical trial (ERSIAS) conducted by Gonzalez in 2015 and 2020, the criteria for inclusion of symptomatic ICASD are as follows: 1)TIA or non-disabling ischemic stroke (occurred within 30 days before admission). 2)Atherosclerotic stenosis or occlusion involving ICA or MCA (70%~100%). 3)Eligible effective events: Despite the application of various medical management, including at least one treatment of antiplatelet drug treatment, the eligible ischemic stroke events still occur. 4)mRS=3. 5) Age range 18-80. At least one of the following criteria should be met if the age ranging between 18 and 49: ? Suffering from insulin dependent diabetes for at least 15 years; ? At least two risk factors for atherosclerosis should exist as follows: ?Blood pressure = 140/90mmHg or antihypertensive therapy; ?Abnormal blood lipids (LDL>130mg/dl or HDL150mg/dl) or receiving l hypolipidemic treatment; ?Smoking; ?Non-insulin dependent diabetes or insulin-dependent diabetes lasting<15 years; ?Any of the following family history: Myocardial infarction, coronary artery bypass grafting, coronary angioplasty or stent implantation, stroke, CEA or internal carotid artery stent implantation; ?Parents or siblings were less than 55 years old for men and less than 65 years old for women at the time of stroke and received vascular surgery ?Previous history of the following diseases: Myocardial infarction, coronary artery bypass grafting, coronary angioplasty or stenting, CEA or internal carotid artery stenting, atherosclerotic peripheral vascular disease, etc. ?The stenosis of extra-cranial carotid artery or vertebral artery, contralateral internal carotid artery, subclavian artery, coronary artery, iliac artery, femoral artery, other lower or upper limb arteries, mesenteric artery or renal artery is found through non-invasive vascular imaging or angiography, which is considered to be caused by atherosclerosis; ?Non-invasive angiography indicates the presence of aortic arch atherosclerosis; ?Noninvasive angiography or angiography indicates the presence of atherosclerotic large artery disease. (6)The patient has menstrual history within 18 months with pregnancy examination (-) (7)The patient volunteered to receive follow-up according to the study protocol (8)Patients can be contacted by telephone (9)Magnetic resonance or angiography demonstrated the poor collateral circulation (ASITN/SIT 0~2) with insufficient perfusion.
Exclusion criteria
Exclusion criteria: 1. Tandem lesions of extra-cranial vessels (stenosis 70%~99% or occlusion). 2. Intracranial vertebral artery or basilar artery stenosis (70%~99%). 3. Expected to perform angioplasty, stent implantation or CEA, on extra-cranial vessels (carotid or vertebral arteries) or intracranial arteries within 30 days before enrollment. 4. Stent, angioplasty or other devices has been implanted in the target vessel. Prepare angioplasty or stent implantation for the target lesion. 5. Angioplasty or stent implantation at intracranial stenosis is planned. 6. Intraluminal thrombus at or near the lesion. 7. Aneurysms at the location, periphery or distal part of intracranial stenosis. 8. Any intracranial tumor (excluding meningioma) or any intracranial vascular malformation. 9. Calcification exist in CT or angiography near the artery according with the enrollment requirements. 10. The patient received thrombolytic therapy within 24 hours. 11. Progression of neurological impairment after 24 hours with admission. 12. Large-area cerebral infarction (infarction diameter>5cm) occurred within 30 days before enrollment, with the risk of hemorrhagic transformation. 13. Any hemorrhagic infarction can be detected within 14 days before enrollment. 14. Hemorrhagic cerebral infarction related to edema effect occurred within 15~30 days before enrollment. 15. Any history of primary cerebral hemorrhage. 16. Any intracranial hemorrhage (subarachnoid hemorrhage, subdural hemorrhage, epidural hemorrhage) within 30 days before enrollment. 17. Any untreated chronic subdural hematoma (thickness>5mm). 18. Intracranial vascular stenosis caused by non-arteriosclerosis: intracranial vascular stenosis caused by arterial dissection; moyamoya disease; any consistent vasculitis; herpes zoster, varicella zoster or other viral vascular diseases; neurosyphilis; vascular stenosis caused by intracranial infection and increased cerebrospinal fluid cells; radioactive vascular stenosis; muscular fiber dysplasia; sickle cell anemia; neurofibromatosis; central nervous system invasive leukemia; postpartum vascular disease; suspected blood vessel in the same posterior embolus. 19. Diseases may be caused by cardiogenic embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, vegetations in the heart, history of myocardial infarction within 3 months, dilated cardiomyopathy, spontaneous echo enhancement of left atrium, ejection fraction1.5; (6) Abnormal coagulation factors; (7) Excessive drinking; (8) Drug abuse; (9) Uncontrolled severe hypertension: systolic blood pressure = 180mmHg, diastolic blood pressure = 115mmHg; (10) Severe liver injury; (11) Severe renal injury. 23. Major surgery scheduled 30 days or 90 days after enrollment. 24. Beyond the indication of warfarin or heparin. Note: subcutaneous heparin is allowed to prevent deep vein thrombosis during hospitalization. 25. Accompany withSerious neurological defects that make patients unable to live independently. 26. Accompany with dementia or other mental diseases, unable to complete outpatient follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any stroke/death within 30 days after enrollment or any ischemic stroke within the eligible arterial area;Add at least one grade on the ASITN/SIR scale within one year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Any stroke/death, myocardial infarction, non-stroke bleeding (subdural or epidural hemorrhage) after 30 days;Cognitive function evaluation getting from mRS;Asymptomatic cerebral hemorrhage and cerebral perfusion; | — |
Countries
China
Contacts
Public ContactRen Bin
Department of Neurosurgery, PLA General Hospital
Outcome results
None listed