Symptomatic intracranial atherosclerotic stenosis/occlusion cerebrovascular disease
Conditions
Interventions
Symptomatic ICASD patients undergoing indirect revascularization and oral aspirin after EDAS surgery :Oral Aspirin
Control group:None
Sponsors
The First Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Based on the SAMMPRIS trial published in the New England Journal in 2011 and the Gonzalez clinical trials (ERSIAS) conducted in 2015 and 2020, eligibility criteria for symptomatic ICASD were: (1) TIA or nondisabling ischemic stroke (no new stroke within 30 days before admission) with stable neurological function for more than 1 month. (2) ICA or MCA atherosclerotic stenosis or occlusion (70%-100%). (3) Preoperative cerebral blood flow metabolic examination indicated hypoperfusion. (4) Eligible effective event: ischemic stroke event occurred despite multiple medical management, including at least one antiplatelet therapy. (5) mRS=140/90mmHg or the need for antihypertensive treatment; b. dyslipidemia (LDL>130mg/dl or HDL150mg/dl or lipid-lowering therapy; c. Smoking d. Non-insulin-dependent diabetes or insulin-dependent diabetes of <15 years duration; e. Family history of any of the following: myocardial infarction, coronary-artery bypass grafting surgery, coronary angioplasty or stenting, stroke, CEA, or internal carotid stenting. Parents or siblings were <55 years old for men and <65 years old for women at the time of the stroke event and had undergone vascular surgery 3) previous history of any of the following diseases: myocardial infarction, coronary artery bypass grafting surgery, coronary angioplasty or stent implantation, CEA or internal carotid artery stent implantation, atherosclerotic peripheral vascular disease, etc. 4) Stenosis of extracranial carotid artery or vertebral artery, contralateral internal carotid artery, subclavian artery, coronary artery, iliac artery, femoral artery, other lower or upper extremity artery, mesenteric artery or renal artery detected by non-invasive angiography or angiography, which is considered to be atherosclerotic; 5) aortic arch atherosclerosis on noninvasive angiography; 6) any evidence of atherosclerotic large artery disease on noninvasive angiography or angiography; (7) The patient had a history of menstruation within 18 months, and pregnancy examination was negative. (8) Patients volunteered to follow up according to the study protocol. (9) Patients can be contacted by telephone.
Exclusion criteria
Exclusion criteria: Exclusion criteria for symptomatic ICASD: (1) Angioplasty of an extracranial (carotid or vertebral) or intracranial artery: stenting or CEA was expected within 30 days before enrollment. (2) Previous treatment with a stent, angioplasty, or other device implantation in the target vessel, or preparation for angioplasty or stenting in the target lesion; (3) The presence of aneurysms at, around or distal to the intracranial stenosis. (4) Any intracranial tumor (other than meningioma) or any intracranial vascular malformation. (5) Patients received thrombolytic therapy within 24 hours. (6) Progression of neurological impairment occurred 24 hours after enrollment. (7) Large area cerebral infarction (infarct diameter >5cm) within 30 days before enrollment with risk of hemorrhagic transformation. (8) Any hemorrhagic infarction within 14 days before enrollment. (9) Hemorrhagic cerebral infarction related to edematous effects within 15 to 30 days before enrollment. (10) Any history of primary cerebral hemorrhage. (11) Presence of any intracranial hemorrhage (subarachnoid hemorrhage, subdural hemorrhage, epidural hemorrhage) within 30 days before enrollment. (12) Any untreated chronic subdural hematoma (thickness >5mm). (13) 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; Intracranial infection and vascular stenosis caused by increased cerebrospinal fluid cells; Radiation vascular stenosis; Muscle fiber dysplasia; Sickle cell anemia; Neurofibromatosis; Central nervous system aggressive leukemia; Postpartum vascular disease; Suspected blood vessels had embolus after recanalization. (14) Presence of the following diseases that may be caused by cardiogenic embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valves, endocarditis, cardiac vegetation, history of myocardial infarction within 3 months, dilated cardiomyopathy, spontaneous left atrial echo enhancement, ejection fraction 1.5; 6) abnormal coagulation factors; 7) alcoholism; 8) drug abuse; 9) severe uncontrolled hypertension: systolic blood pressure >=180mmHg, diastolic blood pressure >=115mmHg; 10) severe liver injury; 11) severe renal injury. (17) Patients with dementia or other mental diseases were unable to complete the outpatient follow-up correctly. (18) Having comorbid diseases with a survival time of less than 3 years. (19) Patients may become pregnant or give birth and are unwilling to use contraceptive measures during the study period. (20) The patient was enrolled in another study that conflicted with our study. Any condition judged by the surgeon to indicate that the patient is not suitable for surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any stroke/death within 30 days after enrollment surgery;Any ischemic stroke within the arterial area involved in ipsilateral surgery that occurred within 3 years after enrollment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Any stroke occurring within 30 days to 3 years after enrollment;Disability or fatal stroke occurring within 30 days to 3 years after enrollment;Death occurs within 30 days to 3 years after enrollment;Cerebral hemorrhage within 30 days to 3 years after enrollment;Surgical complications;Cognitive function evaluation mRS within 3 years and cognitive outcomes at the end of follow-up (MoCA);;Formation pattern of extracranial intracranial vascular collateral circulation in surgical vascular areas within 3 years;Hemodynamic changes; | — |
Countries
China
Contacts
Public ContactRen Bin
The First Medical Center of PLA General Hospital
Outcome results
None listed