Evaluating the Safety and Efficacy of the Maurora® DES in ICAS

This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent versus bare metal stent (BMS) to treat intracranial stenosis of 70-99% degree. The primary endpoint is in-stent restenosis rate(ISR) within 12 months after revascularization procedure of the qualifying lesion during follow-up.

Inclusion criteria

• Age from 18 to 80 years;
• Symptomatic intracranial atherosclerosis (Definition: Stroke or transient ischemic attack [TIA] associated with intracranial atherosclerosis within 90 days of enrollment);
• A major intracranial artery (carotid artery, MCA stem [M1], vertebral artery, or basilar artery) with 70% to 99% stenosis on the angiography (According to WASID method);
• The target lesion length ≤15 mm and the vessel diameter between 2.5mm and 5.0mm, distal vessel diameter >1.5mm;
• Only one stent planned for the target lesion;
• A Modified Rankin Score of ≤ 3;
• Patients understand the purpose and requirements of the study, and can make him/herself understood, and has provided informed consent.

Exclusion criteria

• Ischemic stroke within 2 weeks before the procedure;
• Tandem extracranial or intracranial stenosis (70%-99%) of the target lesion;
• Patients with stroke caused by perforating artery occlusion;
• Severe calcification at target lesion;
• Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 6 weeks;
• History of stenting or angioplasty of an intracranial artery;
• Intracranial tumor, aneurysm or intracranial arteriovenous malformation;
• Intracranial artery stenosis caused by non-atherosclerotic lesions, including: moya-moya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, post-partum vascular disease, suspected vasospasm, suspicious embolism recanalization;
• Presence of any unequivocal cardiac source of embolism (e.g. atrial fibrillation);
• Those who cannot tolerate general anesthesia due to insufficiency of cardiac or pulmonary function, not suitable for procedure;
• Known allergy or contraindication to heparin, aspirin, ticlopidine, ticagrelor, sirolimus, anaesthetics and contrast agents;
• Severe renal and hepatic insufficiency (ALTor AST > 3x upper limit, creatinine > 1.5x upper limit);
• Major surgery within the past 30 days or planned within 90 days, or requiring simultaneous intervention to renal artery, iliac artery, and coronary artery;
• Life expectancy <12 months;
• Pregnant or lactating women, or planning for pregnancy;
• Participated in another investigational device or drug study within 30 days;
• According to the judgement of the investigator, other situations that are not suitable for enrollment.