OPtimizing REperfusion by Primary Intra-Arterial ThRomboLysis for Medium Vessel Occlusion

Ki vehet részt

• Aged 18 years or older
• Clinical diagnosis of acute ischemic stroke
• CT angiography (CTA) or MR angiography (MRA) confirmed primary isolated medium vessel occlusion (i.e. an occlusion of the co-/non-dominant M2, the M3/M4 segment of the MCA, the A1/A2/A3 segment of the ACA, or the P1/P2/P3 segment of the PCA)
• Baseline NIHSS ≥6
• Treatment (arterial puncture) can be initiated 5.1 Within 6 hours of last known well (LKW) OR 5.2 Within 6 to 24 hours of LKW AND evidence of salvageable brain tissue on CT perfusion or perfusion-diffusion MRI (ischemic core volume <50mL, hypo-perfused tissue volume to ischemic core volume ratio >1.4, mismatch volume >10mL). Hypo-perfused tissue is defined as Tmax >6s on CT perfusion or perfusion MRI. Ischemic core is defined as rCBF <30% on CT perfusion or ADC <620μm2/s on diffusion MRI
• Signed informed consent

Ki nem vehet részt

• Any active or recent bleeding (gastrointestinal, urinary tract bleeding, etc.), or previous parenchymal organ surgery or biopsy in the last 1 month
• Evidence of intracranial hemorrhage
• Pre-stroke mRS score ≥ 2
• Severe allergy to contrast agents (non-mild rash allergy) or absolute contraindication to iodine contrast
• Known genetic or acquired bleeding disposition or anticoagulant factors deficiency
• Anticipated life expectancy <6 months due to advanced disease (e.g., malignancy, severe cardiopulmonary disease, etc.)
• Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment)
• Coagulation disorder with INR >1.7 or use of new oral anticoagulants within 48 hours prior to symptom onset
• Platelet count <50×10\^9/L
• Known severe renal insufficiency with glomerular filtration rate <30 ml/min or blood creatinine >220 μmol/L (2.5 mg/dl)
• Rapidly improving symptoms, in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of <6 at randomization
• The intervention procedure is unlikely to be completed as assessed by the investigator
• Suspected cerebral vasculitis, septic embolization, or vascular occlusion due to infective endocarditis
• Suspected arterial dissection
• Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, refractory to treatment
• Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma)
• Women who are pregnant or breastfeeding
• Participation in other clinical trials