A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）

Inclusion criteria

• 1) Age 18-80 years old
• 2) Symptomatic cerebral artery atherosclerotic stenosis (defined as ischemic stroke or TIA due to qualifying lesion stenosis occurring in the past 6 months) with ineffective antiplatelet therapy or hypoperfusion in the territory of qualifying artery or with poor collateral circulation
• 3) Lesion located in a major cerebral artery, including the internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery
• 4) 70%-99% stenosis of qualifying lesion according to WASID method diagnosed by DSA
• 5) Subject with at least one or more risk factors, including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary artery disease, obesity, smoking history, etc
• 6) Subject and/or their legal representatives have the necessary mental capacity to understand the study purpose, agree to participate in the study, and sign the informed consent form

Exclusion criteria

• 1) mRS score≥3
• 2) Last ischemic stroke onset within 2 weeks
• 3) Presence of 2 or more atherosclerotic stenotic lesions in the cerebral arteries requiring interventional or surgical treatment.
• 4) Only perforator infarctions in the territory of qualifying artery according to preoperative imaging
• 5) Hemorrhagic transformation in the territory of qualifying artery. Any parenchymal, subarachnoid, subdural, or extradural hemorrhage within 30 days prior to procedure, or untreated chronic subdural hematoma(≥5 mm) according to preoperative imaging
• 6) Restenosis of qualifying lesion due to previous stenting.
• 7) Qualifying lesion with severe calcification, extreme eccentricity, or extreme angulation which may affect stent deployment
• 8) Stenosis caused by non-atherosclerotic lesions, such as arterial dissection, moya-moya disease, or vasculitis
• 9) Concomitant severe stenosis (≥70% stenosis as measured by the WASID method) in the distal or proximal to qualifying lesion
• 10) Concomitant multiple stenoses where qualifying lesions cannot be identified
• 11) Thrombus in the qualifying artery or complete occlusion of the qualifying artery
• 12) Severe calcification or tortuosity of qualifying artery to prevent stent from successful positioning and dilatation
• 13) Stenting in qualifying artery within one year
• 14) Concomitant aneurysms requiring treatment
• 15) Concomitant intracranial malignant tumors, intracranial arteriovenous malformations, intracranial venous sinus thrombosis, or other conditions inappropriate to participate in the study
• 16) Resistant hypertension (systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg) despite use of medication
• 17) Acute myocardial infarction within 4 weeks prior to enrollment, or suspected cardiogenic embolism
• 18) Subjects with severe systemic diseases that cannot tolerate surgery, such as severe hepatic or renal impairment
• 19) Severe cognitive impairment or mental diseases
• 20) Contraindications to anticoagulants or antiplatelet drugs, such as anticoagulant or antiplatelet drug allergy, active bleeding, or coagulation disorder
• 21) Subjects with allergy or suspected allergy to anesthetics, contrast agents, rapamycin, polylactic acid, nickel-titanium alloy, cobalt-chromium alloy, stainless steel, and other stent materials, medications, and intraoperative medications
• 22) Women who are pregnant or breastfeeding
• 23) Subjects who are participating or planning to participate in any drug or device clinical study at the time of enrollment
• 24) Life expectancy ≤ 1 year
• 25) Other conditions inapplicable to participate in the study according to investigators' judgment