PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of primary intra-arterial thrombolysis in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset.
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.
Evidence of intracranial hemorrhage.
Pre-stroke mRS score ≥ 2.
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.
Parallel
Primary intra-arterial thrombolysis
Combination productPrimary intra-arterial thrombolysis, in addition to standard medical treatment
Standard medical treatment
Other interventionStandard medical treatment
The modified Rankin Scale score (mRS) 0-1
The proportion of mRS 0-1 at 90 (±14) days.
Level of disability
The shift analysis of mRS at 90 (±14) days (mRS 5 and 6 merged)
The modified Rankin Scale score (mRS) 0-2
The proportion of mRS 0-2 at 90 (±14) days;
Quality of life (EQ-5D-5L)
Quality of life measured by the EQ-5D-5L scale score at 90 (±14) days
Neurologic deficit (NIHSS score) changes
The change of NIHSS score from baseline at 24 (±12) hours
Safety outcome: Symptomatic intracranial hemorrhage (sICH)
Symptomatic intracranial hemorrhage (sICH) within 36 hours (according to Heidelberg criteria)
Safety outcome: Any intracranial hemorrhage
Any intracranial hemorrhage within 36 hours (according to Heidelberg classification);
Safety outcome: Mortality
All-cause mortality within 90 days.
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