Symptomatic intracranial atherosclerosis stenosis
Conditions
Interventions
Stenting plus medical treatment group:Stenting and medical treatment
Sponsors
The Second Affiliated Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 years or older; 2) Symptomatic intracranial atherosclerosis stenosis in anterior circulation; 3) Stroke or TIA occurred in the past 90 days, resulting in symptomatic intracranial artery stenosis in the responsible vessels of this study, ineffective after standard drug treatment or high-risk patients evaluated by experts; 4) Large arterial atherosclerosis of TOAST subtypes; 5) Degree of stenosis is 70%-99%; 6) Lesion length = 2.0 mm; 7) CTP imaging of the head shows hypoperfusion in the responsible area of the diseased vessel or CTA collateral circulation score <2 or DSA collateral circulation ASTIN/SIR <grade 3; 8) Intracranial stents are expected to be delivered to responsible lesions; 9) Mrs score before onset <= 2; 10) Written informed consent is obtained from patients and/or their relatives.
Exclusion criteria
Exclusion criteria: 1) Acute ischemic stroke in the last 3 weeks; 2) Perforator artery strokes; 3) There is > 50% stenosis or occlusion of serial extracranial or intracranial vessels at the proximal or distal end of the target vessel 4) There was > 50% stenosis or occlusion of large intracranial vessels (vertebral artery and basilar artery) with posterior circulation; 5) Non-atherosclerotic intracranial stenosis, including arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus; 6) Potential cardiac embolism; 7) Severe vascular tortuosity or anatomy that would preclude stenting or angiography; 8) Severe calcification at target lesion; 9) Concomitant intracranial tumour, aneurysm or arteriovenous malformation; 10) Previous spontaneous intracerebral (parenchymal) or other intracranial (subarachnoid, subdural, or epidural) hemorrhage within 30 days; 11) Myocardial infarction within previous 30 days; 12) Allergic to and known contraindications for medications (heparin, contrast agents, aspirin and clopidogrel) or operating devices; 13) Refractory to general anesthesia; 14) A history of systemic hemorrhage in the last 1 months; 15) A history of major surgery in the last 1 month; 16) HGB400mg/dl (22.2mmol/L); 17) Severe liver impairment (AST or. ALT >3 times normal, cirrhosis)severe renal insufficiency (eGFR 1.7; 19) Pregnant or lactating women, or those planning to become pregnant within one year; 20) Life expectancy of <1 year; 21) Not expected to complete; 22) Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Vessel Stroke Event within 30 days;Transient ischemic attack within 30 days;Mortality rate within 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stroke Event, Transient ischemic attack, and mortality rate within 6 and 12 months;Procedural complications;Stent restenosis within 1 years of follow-up ( >50%);NIHSS score, mRS score, Barthel index score, EQ 5D scale score within 1 year of follow-up;Cardiovascular events related to stent or drug therapy within 1 years of follow-up;Compliance with medication within 1 year of follow-up;Incidence of non-hemorrhagic adverse events; | — |
Countries
China
Contacts
Public ContactShuai Jie
The Second Affiliated Hospital, Army Medical University
Outcome results
None listed