Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)

Korábbi kezelés

• Already received intravenous thrombolysis;
• Concurrent malignant tumors or severe systemic diseases with an expected survival time of less than 90 days;
• Participation in another clinical interventional trial within 30 days prior to randomization or currently participating in another clinical interventional trial;

Más betegség

• Intracranial hemorrhage confirmed by cranial CT or MRI;
• Allergy to contrast agents or tenecteplase;
• Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and failure to control with oral antihypertensive medications;
• History of bleeding within the past month (gastrointestinal or urinary tract bleeding);
• Severe mental disorders or inability to provide informed consent and comply with follow-up due to dementia;

Laborértékek

• Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR \> 1.7, or use of novel oral anticoagulants within 48 hours;
• Blood glucose \< 2.8 mmol/L (50 mg/dL) or \> 22.2 mmol/L (400 mg/dL), platelet count \< 100 × 10\^9/L;
• Chronic hemodialysis or severe renal insufficiency (glomerular filtration rate \< 30 mL/min or serum creatinine \> 220 μmol/L (2.5 mg/dL));

Egyéb

• Planned mechanical thrombectomy;
• Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation;
• Pregnant or breastfeeding women;
• Intracranial aneurysms or arteriovenous malformations;
• Occlusions in multiple vascular territories confirmed by CTA/MRA;
• Other reasons that the investigator deems inappropriate for participation in the trial

• Age ≥18 years old
• Acute isolated intracranial medium vessel occlusion (Distal middle cerebral artery M2; M3 and M4 segments of the middle cerebral artery; A1-A4 segments of the anterior cerebral artery; P1-P3 segments of the posterior cerebral artery), confirmed by imaging, with symptom onset to randomization within 24 hours;
• NlHSS score ≥ 5
• CT scan performed within 24 hours confirming that the ischemic lesion does not involve more than one-third of the territory supplied by the responsible vessel (no evidence of early large infarction)
• Patients with premorbid mRS 0 or 1
• Written informed consent obtained from the participant or a legally authorized representative