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

NCT07137832 | Recruiting Phase 3 DMC

• 1 other identifier: SYSKY-2025-574-02
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The modified Rankin Scale score (mRS) 0-1

  The proportion of mRS 0-1 at 90 (±14) days.

  90 (±14) days

Secondary Outcomes (4)

• Level of disability

  90 (±14) days

• The modified Rankin Scale score (mRS) 0-2

  90 (±14) days

• Quality of life (EQ-5D-5L)

  90 (±14) days

• Neurologic deficit (NIHSS score) changes

  24 (±12) hours

Other Outcomes (3)

• Safety outcome: Symptomatic intracranial hemorrhage (sICH)

  24 (±12) hours

• Safety outcome: Any intracranial hemorrhage

  24 (±12) hours

• Safety outcome: Mortality

  90 (±14) days

Study Arms (2)

Intervention group

EXPERIMENTAL

Intra-arterial thrombolysis as adjunct to endovascular treatment, in addition to standard medical treatment

Combination Product: Intra-arterial thrombolysis as adjunct to endovascular treatment

Control group

ACTIVE COMPARATOR

Only standard medical treatment

Other: Standard medical treatment

Interventions

Standard medical treatment OTHER

Standard medical treatment

Control group

Intra-arterial thrombolysis as adjunct to endovascular treatment COMBINATION_PRODUCT

Intra-arterial thrombolysis as adjunct to endovascular treatment, in addition to standard medical treatment

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Suspected cerebral vasculitis, septic embolization, or vascular occlusion due to infective endocarditis.
• Suspected arterial dissection.
• 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.
• 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.
• Any active or recent bleeding (gastrointestinal, urinary tract bleeding, etc.), or previous parenchymal organ surgery or biopsy in the last 1 month.
• Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, refractory to treatment.
• Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl).
• Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma).
• Anticipated life expectancy \<6 months due to advanced disease (e.g., malignancy, severe cardiopulmonary disease, etc.).

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yamei Tang

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenhong Deng

CONTACT

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

Xinguang Yang

CONTACT

86-20-81332619; yangxinguang0926@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after the trial completion.
• Access Criteria: The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.

Locations

CN (1)