symptomatic intracranial atherosclerotic stenosis and carotid artery stenosis
Conditions
Interventions
experimental group:intensive medical therapy plus stenting
control group:intensive medical therapy alone
Sponsors
The Second Affiliated Hospital, Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Eligible patients aged between 30 and 80 years, no gender limitation 2. Symptomatic patients with atherosclerotic ICAS or CAS: presented with TIA or stroke within the past 6 months attributed to stenosis of a major intracranial artery or carotid artery 3. Degree of stenosis: 50%–99% ( must be confirmed by CT angiography or catheter angiography for enrollment) 4. Insufficient perfusion in the territory of the responsible artery within previous 2 weeks (confirmed by CTP/DSA that CBF decreased by more than 30% compared with contralateral lesion >= 30%,ASITN/SIR score < 3); 5. Patients understand the purpose and requirements of the study and have signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Thrombolytic therapy, evolving stroke or progressive neurologic signs within 24 hours before enrollment. 2. Fresh infarctions identified on MRI (indicated as high signals on DWI series) upon enrollment. 3. Massive cerebral infarction (>1/2 MCA territory or infarct size >5 cm on CT or MRI) to place patient at risk of hemorrhagic transformation; 4. Patients with disabled stroke, baseline mRS score >= 3; 5. Tandem extracranial or intracranial stenosis (>70%) that is proximal or distal to the target intracranial lesion; 6. Non atherosclerotic arterial stenosis (e.g., dissection, moyamoya disease, vasculitis caused by infection, autoimmune disease, post irradiation, postpartum state; developmental or genetic abnormalities, such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm); 7. Potential cardiogenic emboli (such as such as atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombosis, myocardial infarction within previous 6 weeks). 8. Accompanied with spontaneous intracerebral hemorrhage or other intracranial (subarachnoid, subdural, or epidural) hemorrhage, intracranial tumors,any aneurysm or intracranial vascular malformations. 9. Ultrasonic or CT angiographic evidence of severe calcification at the target stenotic artery that is suitable to stent planting. 10. Severe vascular tortuosity or other anatomic factors that would preclude the stability access and safe introduction of a guiding catheter or stent placement to the lesion. 11. Intolerance or allergic reaction to any of the medication, including heparin, aspirin, clopidogrel, anesthetics, contrast agent and stents composition. 12. Active bleeding diathesis, coagulopathy or not acceptable the dual antiplatelet therapy due to other diseases. 13. Pregnant and lactating women; 14. Severe dementia or psychiatric problems that prevent the patients from completing the follow-up visits required by the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| compound endpoint events including any stroke, cardiovascular events or death; | — |
Secondary
| Measure | Time frame |
|---|---|
| ischemic stroke in the territory of the symptomatic offending artery or death;lab test;restenosis (>50%) related to stenting;mRS score; | — |
Countries
China
Contacts
Public ContactXiaoli Min
The Second Affiliated Hospital, Kunming Medical University
Outcome results
None listed