China Angioplasty & Stenting for Symptomatic Intracranial Severe Stenosis

Inclusion criteria：

1. Eligible patients aged between 30-80 years; intracranial arterial stenosis related tothe following non-atherosclerotic factors will be not be considered: arterialdissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster orother viral vasculopathy; neurosyphilis; any other intracranial infection; anyintracranial 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;
2. Symptomatic ICAS: presented with TIA or stroke within the past 12 months attributed to 70%-99% stenosis of a major intracranial artery (internal carotid artery, MCA [M1],vertebral artery, or basilar artery);
3. Degree of stenosis: 70%-99%; stenosis degree must be confirmed by catheter angiographyfor enrollment in the trial;
4. There might be remote infarctions on MRI scan, which could be accounted by theocclusion of the terminal cortical branches or hemodynamic compromise (perforatorocclusion excluded). Infarction due to perforators occlusion is defined as basalganglia or brainstem/thalamus infarction related with MCA or BA stenosis;
5. Expected ability to deliver the stent to the lesion;
6. All the patients should be performed with stenting beyond a duration of 3 weeks fromthe latest ischemic symptom onset;
7. No recent infarctions identified on MRI (indicated as high signals on DWI series) uponenrollment;
8. No massive cerebral infarction (>1/2 MCA territory), intracranial hemorrhage, epiduralor sub-dural hemorrhage, and intracranial brain tumor on CT or MRI scan;
9. mRS scale score of <=2;
10. Target vessel reference diameter must be measured to be 2.00 mm to 4.50 mm; targetarea of stenosis is <=14 mm in length;
11. No childbearing potential or has a negative pregnancy test within the past 1 weekprior to study procedure; female patients had normal menses in the last 18 months;
12. Patient is willing and able to return for all follow-up visits required by theprotocol;
13. Patients understand the purpose and requirements of the study and have signed informedconsent form.

Exclusion criteria:

1. Refractory to general anesthesia; patients were not able to be overcome bypre-treatment with medical therapy.
2. Any condition that precludes proper angiographic assessment.
3. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximalor distal to the target intracranial lesion.
4. Bilateral intracranial VA stenosis of 70%-99% and uncertainty about which lesion issymptomatic (e.g., if patient has pon, midbrain, temporal and occipital symptoms).
5. Presence of a previously placed intravascular stent or graft in the ipsilateraldistribution within 30 days.
6. Previous treatment of target lesion with a stent, angioplasty, or other mechanicaldevice, or plan to perform staged angioplasty followed by stenting of target lesion.
7. Severe vascular tortuosity or anatomy that would preclude the safe introduction of aguiding catheter, guiding sheath or stent placement.
8. Plan to perform concomitant angioplasty or stenting of an extracranial. vessel tandemto an ipsilateral intracranial stenosis.
9. Presence of intraluminal thrombus proximal to or at the target lesion.
10. Any aneurysm proximal to or distal to intracranial stenotic artery.
11. Intracranial tumors or any intracranial vascular malformations.
12. Computed tomographic or angiographic evidence of severe calcification at targetlesion.
13. Thrombolytic therapy within 24 hours before enrollment.
14. Evolving stroke or progressive neurologic signs within 24 hours before enrollment.
15. Stroke of sufficient size (>5cm on CT or MRI) to place patient at risk of hemorrhagictransformation during the procedure; hemorrhagic transformation of an ischemic strokewithin the past 15 days.
16. Previous spontaneous intracerebral (parenchymal) or other intracranial (subarachnoid,subdural, or epidural) hemorrhage within 30 days.
17. Untreated chronic subdural hematoma >5 mm in thickness.
18. Other cardiac sources of emboli such as left ventricular aneurysms, intracardiacfilling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcifiedaortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septalaneurysm, left atrial myxoma.
19. Myocardial infarction within previous 30 days.
20. Chronic atrial fibrillation; any episode of paroxysmal atrial fibrillation within thepast 6 months, or history of paroxysmal atrial fibrillation requiring chronicanticoagulation.
21. Intolerance or allergic reaction to any of the medical therapy, including aspirin,clopidogrel, heparin, and local or general anesthetics.
22. History of life-threatening allergy to contrast medium. If not life-threatening andcan be effectively pre-treated, patient can be enrolled at physicians' discretion.
23. Recent gastro-intestinal bleed that would interfere with anti-platelet therapy.
24. Active bleeding diathesis or coagulopathy; active peptic ulcer disease, major systemichemorrhage within 30 days, active bleeding diathesis, platelets count <125,000,hematocrit <30, Hgb <10 g/dl, uncorrected INR >1.5, bleeding time >1 minute beyondupper limit normal, or heparin-associated thrombocytopenia that increases the risk ofbleeding, uncontrolled severe hypertension (systolic BP>180 mm hg or diastolic BP>115mm hg), severe liver impairment (AST or ALT >3 times normal, cirrhosis), creatinine >265.2μmol/l (unless on dialysis)
25. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30days or planned in the next 90 days after enrollment.
26. Indication for warfarin or heparin beyond enrollment (note: exceptions allowed for useof systemic heparin during stenting procedure or subcutaneous heparin for deep venousthrombosis prophylaxis while hospitalized).
27. Inability to understand and cooperate with study procedures or sign informed consent
28. Severe dementia or psychiatric problems that prevent the patients from following anoutpatient program reliably.
29. Pregnancy or of childbearing potential and unwilling to use contraception for theduration of this study
30. Actively participating in another drug or device trial that has not completed therequired protocol follow-up period.