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OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Medium Vessel Occlusion | Clinical Trials | Clareo Health

RECRUITINGPHASE3

OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Medium Vessel Occlusion

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

NCT07137832•Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

Detailed 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 intra-arterial thrombolysis as adjunct to endovascular treatment in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset. The primary outcome is the proportion of patients with a 90-day modified Rankin Scale (mRS) of 0-1. Eligible patients will be randomly assigned at a ratio of 1:1 into the intervention group to receive intra-arterial thrombolysis as adjunct to endovascular treatment, or the control group to receive only standard medical management. A total of 530 participants (265 per group) are anticipated to be recruited for this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 years or older.
•2. Clinical diagnosis of acute ischemic stroke.
•3. 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).
•4. Baseline NIHSS ≥6.
•5. 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.
•6. Signed informed consent.

Exclusion Criteria

•1. Evidence of intracranial hemorrhage.
•2. Pre-stroke mRS score ≥ 2.
•3. 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.
•4. The intervention procedure is unlikely to be completed as assessed by the investigator.
•5. Suspected cerebral vasculitis, septic embolization, or vascular occlusion due to infective endocarditis.
•6. Suspected arterial dissection.
•7. Severe allergy to contrast agents (non-mild rash allergy) or absolute contraindication to iodine contrast.
•8. Known genetic or acquired bleeding disposition or anticoagulant factors deficiency.
•9. Coagulation disorder with INR \>1.7 or use of new oral anticoagulants within 48 hours prior to symptom onset.
•10. Platelet count \<50×10\^9/L.
+8 more criteria

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

October 9, 2025

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2028

Last Updated

December 15, 2025

Enrollment

530

ESTIMATED participants

Conditions

Acute Ischemic Stroke

Interventions

Intra-arterial thrombolysis as adjunct to endovascular treatment

COMBINATION_PRODUCT

Standard medical treatment

OTHER

Contacts

Zhenhong Deng

CONTACT

86-20-81332619 dengzhh58@mail.sysu.edu.cn

Xinguang Yang

CONTACT

86-20-81332619 yangxinguang0926@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Medium Vessel Occlusion

Inclusion Criteria

Exclusion Criteria

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