Sodium Sivelestat With Mechanical Thrombectomy for Acute Stroke: A Pilot Study

Inclusion criteria

• Symptoms and signs consistent with focal ischemia in the anterior or posterior circulation;
• Large vessel occlusion of the anterior or posterior circulation (internal carotid artery, M1/M2 segment of the middle cerebral artery, vertebral artery, or basilar artery) confirmed by CTA/MRA/DSA;
• Undergoing mechanical thrombectomy;
• Age ≥18 years, both male and female;
• Pre-stroke modified Rankin Scale (mRS) score ≤1;
• Time from symptom onset to thrombectomy ≤24 hours, including wake-up stroke or unwitnessed stroke; symptom onset is defined as the "last known well" (LKW);
• National Institutes of Health Stroke Scale (NIHSS) score ≥6 at admission;
• ASPECTS ≥3 for anterior circulation occlusion, or pc-ASPECTS ≥6 for posterior circulation occlusion;
• Written informed consent provided by the patient or their legal representative.

Exclusion criteria

• Simultaneous acute occlusion of both anterior and posterior circulation or bilateral hemispheric large vessel occlusions;
• Complete clinical recovery at the end of EVT procedure;
• Arterial dissection or intraoperative hemorrhage indicated by post-thrombectomy DSA;
• Sedated and intubated patients without baseline NIHSS assessment;
• Seizure at stroke onset interfering with baseline NIHSS assessment;
• Bilateral fixed dilated pupils;
• Severe allergy or absolute contraindication to sodium sivelestat;
• Severe allergy or absolute contraindication to iodinated contrast agents;
• Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, uncontrolled despite antihypertensive therapy;
• Blood glucose <50 mg/dl (2.8 mmol/L) or >400 mg/dl (22.2 mmol/L);
• Platelet count <50×10⁹/L;
• Congenital or acquired bleeding diathesis, coagulation factor deficiency, or current use of oral anticoagulants with INR >1.7;
• Severe renal impairment, defined as serum creatinine >3.0 mg/dl (265.2 μmol/L), GFR <30 ml/min, or requirement for hemodialysis/peritoneal dialysis;
• Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patient);
• Suspected vasculitis or septic embolism;
• Suspected aortic dissection;
• Pre-existing neurological or psychiatric disorders interfering with stroke assessment;
• Pregnancy or lactation;
• Confirmed rheumatic/autoimmune disease with long-term use of immunosuppressants or corticosteroids;
• Current treatment with chemotherapy or other immunomodulatory agents (e.g., recombinant human granulocyte colony-stimulating factor, Xuebijing, ulinastatin, etc.);
• Participation in another clinical trial that may interfere with study outcomes;
• Any other condition that investigators deem unsuitable for participation or that may pose significant risk to the patient.