Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis

Inclusion criteria

• Age ≥ 18 years old and ≤ 80 years old, regardless of gender.
• Symptomatic intracranial arterial stenosis (TIA/ischemic stroke within 180 days attributed to intracranial arteries including the intracranial internal carotid artery, middle cerebral artery, intracranial vertebral artery, or basilar artery, with stenosis severity ≥70% and ≤99% measured by DSA using WASID criteria), currently receiving at least one antiplatelet therapy;
• Poor collateral circulation or hypoperfusion in the target vessel territory (Poor collateral circulation: American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) score < 3; Hypoperfusion: 1. The cerebral blood flow (CBF) in the target artery territory decreases by > 30% during CT or magnetic resonance perfusion imaging (MR perfusion); or 2. There are hemodynamic ischemic lesions on MRI or CT, such as watershed infarction);
• Target lesion vessel diameter 1.0-5.5 mm with lesion length ≤40 mm (If: 2.25 mm ≤ target vessel diameter ≤4.0 mm and lesion length ≤15 mm, enroll in randomized controlled study; 1.0 mm ≤ target vessel diameter <2.25 mm or 4.0 mm < target vessel diameter ≤5.5 mm or 15 mm < lesion length ≤40 mm, enroll in single-arm cohort study);
• mRS score ≤ 2;
• Patient or legal guardian voluntarily participates and signs the written ICF, with willingness to comply with protocol-specified examinations and follow-up.

Exclusion criteria

• History of prior stent implantation or surgical treatment at the target lesion;
• Intracranial hemorrhage within 30 days preoperatively or presence of untreated chronic subdural hematoma ≥5 mm;
• Major surgical procedure within 30 days prior to the procedure;
• Acute ischemic stroke within 14 days prior to the procedure;
• Symptomatic carotid stenosis ≥50% outside the target lesion, or coexisting intracranial/extracranial vascular stenosis ≥70% requiring intervention;
• Severe calcification, significant stenosis, or tortuosity of the target vessel precluding device deployment as assessed by investigators;
• Intracranial tumor, arteriovenous malformation, or tandem aneurysms proximal/distal to the target lesion;
• Non-atherosclerotic stenosis etiology (e.g., arterial dissection, moyamoya disease, vasculitis);
• Cardiac thromboembolic sources (e.g., atrial fibrillation, left ventricular thrombus, myocardial infarction within 6 weeks);
• Uncontrolled hypertension (persistent systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg);
• Contraindications to antiplatelet/anticoagulant therapy, coagulopathy or bleeding diathesis precluding intervention per investigator judgment;
• Severe comorbidities: cardiac failure (New York Heart Association (NYHA) Class III-IV), respiratory/renal failure (serum creatinine >3.0 mg/dL (264 μmol/L)), Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) more than 3 times the upper limit of the normal value), active malignancy;
• Hypersensitivity to rapamycin, polylactic-co-glycolic acid, nitinol, platinum-tungsten, anesthetics, or contrast agents;
• Life expectancy <1 year;
• Pregnancy, lactation, or planned pregnancy within 1 year;
• Concurrent participation in other clinical trials without completing primary endpoint follow-up;
• Cognitive impairment or psychiatric disorders compromising protocol compliance; other exclusionary conditions per investigator discretion.