To assess the safety and efficacy of beyond time window TNK intravenous thrombolysis for distal Medium Vessel Occlusion (MeVO) related stroke in a prospective randomized clinical trial.
Evidence of a primary (e.g., not secondary to endovascular therapy of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the co/non-dominant M2 segment*, M3, or M4 segment of the middle cerebral artery (MCA), the anterior cerebral artery (ACA) (A1, A2, A3, or A4 segments), or the posterior cerebral artery (PCA) (P1, P2, P3, or P4 segments);
Age ≥18 years;
Premorbid mRS 0-1;
Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥4 at the time of randomization.
Received intravenous thrombolysis prior to randomization;
Allergy to Tenecteplase;
Seizures, or other neurological/mental illness at stroke onset if it precludes obtaining an accurate baseline NIHSS;
Patients planned to undergo MT or other endovascular treatments (e.g., intra-arterial thrombolysis);
Parallel
Intravenous thrombolysis
DrugPatients in the TNK treatment group will receive TNK intravenous thrombolysis after MeVO is determined, and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg,
Standard medical management
Other interventionStandard medical management
Rates of 90 day good functional outcomes
(mRS score ≤ 1 is defined as good prognosis)
2. Proportion of patients with functional independence outcome (mRS 0-2) at day 90
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
3. Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Symptomatic intracranial hemorrhage (sICH)
SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 24 hours , or any hemorrhage leading to death.
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