Intra-arterial Thrombolysis For Acute Ischemic Stroke With Medium Vessel Occlusion

Summary

Study purpose: A multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) phase III trial is planned to evaluate the efficacy and safety of intra-arterial thrombolysis (IAT) in patients with acute ischemic stroke caused by medium vessel occlusion (MeVO), compared with best medical management alone. Eligible participants (aged 18-80 years, baseline NIHSS score 6-25 or 3-5 with disabling deficits, confirmed MeVO within 24 hours of symptom onset) will be randomly assigned 1:1 to the intra-arterial thrombolysis plus best medical management group or the best medical management alone group. Primary endpoint: proportion of patients with favorable functional outcome (modified Rankin Scale score 0-2) at 90±7 days post-randomization. Secondary endpoints: 1. Recanalization rate (meTICI ≥ 2b) at 24±12 hours post-randomization; 2. Early neurological improvement (NIHSS score change from baseline) at 7±1 days or discharge; 3. Overall distribution of mRS scores at 90±7 days (shift analysis); 4. Excellent functional outcome (mRS score 0-1) at 90±7 days; 5. Health-related quality of life (EQ-5D-5L) at 90±7 days; 6. Functional independence (Barthel Index score 95-100) at 90±7 days; 7. Symptomatic intracranial hemorrhage (sICH) per Heidelberg criteria within 48 hours; 8. Early neurological deterioration (NIHSS increase ≥ 4 points or any single item increase ≥ 2 points) within 7 days; 9. Any intracranial hemorrhage within 48 hours; 10. Procedure-related complications; 11. All-cause mortality within 90±7 days.

Timeline

Start

2026-07-01

Primary completion

2028-07-30

Completion

2029-08-31

Drugs

Indications