Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial

This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent combined with aggressive medical treatment versus standard medical treatment to treat symptomatic intracranial atherosclerotic disease. Primary efficacy endpoints (any of the following): 1) any stroke or death within 30 days after enrollment, 2) any stroke or death within 30 days after a revascularization procedure of the qualifying lesion during follow-up, 3) ischemic stroke in the territory of the qualifying artery beyond 30 days to 1 year.

Inclusion criteria

• Age from 18 to 85 years
• Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery [C5-C7], middle cerebral artery [M1], vertebral artery [V4], or basilar artery) on CTA (According to WASID method)
• The diameter of the target vessel between 2.0mm - 4.5mm
• The stenosis lesion length ≤ 14 mm
• Baseline modified Rankin Scale (mRS) score ≤ 3
• Patient understands the purpose and requirements of the study, and has provided informed consent

Exclusion criteria

• Ischemic stroke occurred within 7 days before enrolment
• Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if stenosis or occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery)
• Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (NOTE: an exception is that if bilateral vertebral arteries with 70%-99% stenosis but unequal in size, the dominant side is considered as symptomatic)
• Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery
• Stroke caused by perforating artery occlusion
• CT angiographic evidence of severe calcification at target lesion
• Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks
• Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc
• History of stenting of an intracranial artery
• Presence of any unequivocal cardiac source of embolism
• Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation
• Cannot tolerate dual antiplatelet therapy
• Contraindications to heparin, rapamycin, contrast and local or general anesthesia
• Hemoglobin<100g/L, platelet count <100×109/L
• Severe hepatic and renal dysfunction
• INR>1.5 or there are uncorrectable factors leading to bleeding
• Major surgery within the past 30 days or planned within 90 days
• Renal artery, iliac artery, and coronary artery requiring simultaneous intervention
• Life expectancy <1 year
• Pregnant or lactating women
• Cannot complete the follow-up due to cognitive, emotional or mental illness
• Other situations that are not suitable for enrolment according to the judgement of the investigator
• Enrolment in another study that would conflict with the current study