Tests clot-dissolving drug delivered directly into artery for stroke

Trial details

Who runs it

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Trial code

NCT07137832

Record updated

24 August 2026

Original description

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.Read full original descriptionShow less

OPtimizing REperfusion by Primary Intra-Arterial ThRomboLysis for Medium Vessel Occlusion (PEARL-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial

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.

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT07137832