IAT-MeVO is an international, multicenter, prospective, randomised, open-label, blinded end-point assessed (PROBE) trial, to evaluate the efficacy and safety of endovascular therapy (EVT) \[intra-arterial thrombolysis (IAT)-based\] versus best medical management (BMT) in patients with acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) who are ineligible for intravenous thrombolysis (IV) within 24 h of onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
614
Patients will receive IAT-based EVT in addition to medical treatment. IAT with TNK will be performed first. If adequate dosing fails to achieve reperfusion, the surgical team may evaluate the need for aspiration or stent retriever thrombectomy. For second-order branches (M2/A1/P1 segments), the number of retrieval attempts must not exceed three; for third-order branches (M3/A2/P2 and beyond), no more than two attempts are allowed. \*Arterial thrombolysis protocol: Dose: 0.125 mg/kg body weight, maximum 12.5 mg \*No restrictions will be placed on the choice of aspiration catheters or stent retrievers used in this study.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Excellent functional outcome
The proportion of patients with an modified Rankin Scale (mRS) score of 0-1. The mRS is a clinician-reported measure of global disability widely used to assess outcomes in patients with stroke and other neurological disorders. It ranges from 0 (no symptoms) to 6 (death).
Time frame: 90 days
Good functional outcome
The proportion of patients with an modified Rankin Scale (mRS) score of 0-2. The mRS is a clinician-reported measure of global disability widely used to assess outcomes in patients with stroke and other neurological disorders. It ranges from 0 (no symptoms) to 6 (death).
Time frame: 90 days
Distribution of functional outcome
The modified Rankin Scale (mRS) score at 90 days and the utility weighted mRS. The mRS is a clinician-reported measure of global disability widely used to assess outcomes in patients with stroke and other neurological disorders. It ranges from 0 (no symptoms) to 6 (death).
Time frame: 90 days
Health-related quality of life (HRQoL)
Quality of life measured using EQ-5D-5L.The EuroQol 5-Dimension 5-Level instrument (EQ-5D-5L) is a generic, preference-based measure of health-related quality of life. It generates two primary scores: 1) a utility index score (typically ranging from -0.573 to 1.00, depending on the value set, where 1 represents 'full health'), and 2) a self-rated Visual Analog Scale (EQ-VAS) score (ranging from 0 to 100). For both scores, a higher value indicates a better health outcome.
Time frame: 90 days
Neurological status
Neurological status measured by National Institutes of Health Stroke Scale (NIHSS) score. The National Institutes of Health Stroke Scale (NIHSS) is a standardized 15-item neurologic examination tool used to quantify the severity of acute cerebral infarction. Scores range from 0 to 42, with higher scores indicating more severe neurological deficit.
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Time frame: 72±12 hours
Early neurological improvement
Achieving an NIHSS score of 0-1 or a decrease of ≥4 points from the baseline NIHSS score. The National Institutes of Health Stroke Scale (NIHSS) is a standardized 15-item neurologic examination tool used to quantify the severity of acute cerebral infarction. Scores range from 0 to 42, with higher scores indicating more severe neurological deficit.
Time frame: 72±12 hours
Final infarct volume
Final infarct size based on CT or MRI
Time frame: 24-72 hours
Symptomatic intracranial hemorrhage (sICH)
sICH defined by SIST-MOST criteria
Time frame: 7 days
Any intracranial hemorrhage
Any intracranial hemorrhage was a key safety outcome, encompassing any acute bleeding within the cranial cavity. All suspected events were confirmed by follow-up CT or MRI scans.
Time frame: 7 days
Malignant cerebral edema
The incidence of malignant edema, adjudicated by the central imaging core lab according to follow-up imaging and medical history
Time frame: 7 days
All-cause mortality
Death
Time frame: 7 days
All-cause mortality
Death
Time frame: 90 days
EVT-related adverse events
adverse events post-EVT
Time frame: 4 days