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IAT-MeVO Trial Domain Within the ACT-GLOBAL Adaptive Platform Trial

No phase Interventional Acute Ischemic Stroke Due to Medium-vessel-occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endovascular Treatment.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke Due to Medium-vessel-occlusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of Endovascular Therapy With Intra-Arterial Thrombolysis for Medium Vessel Occlusion Stroke--the IAT-MeVO Trial

Overview

IAT-MeVO is an international, multicenter, prospective, randomised, open-label, blinded end-point assessed (PROBE) trial, to evaluate the efficacy and safety of endovascular therapy (EVT) \[intra-arterial thrombolysis (IAT)-based\] versus best medical management (BMT) in patients with acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) who are ineligible for intravenous thrombolysis (IV) within 24 h of onset.

Interventions

  • Procedure Endovascular Treatment
    Patients will receive IAT-based EVT in addition to medical treatment. IAT with TNK will be performed first. If adequate dosing fails to achieve reperfusion, the surgical team may evaluate the need for aspiration or stent retriever thrombectomy. For second-order branches (M2/A1/P1 segments), the number of retrieval attempts must not exceed three; for third-order branches (M3/A2/P2 and beyond), no more than two attempts are allowed. \*Arterial thrombolysis protocol: Dose: 0.125 mg/kg body weight,

Primary outcome measures

  • Excellent functional outcome [Time frame: 90 days]
Secondary outcome measures (12)
  • Good functional outcome [Time frame: 90 days]
  • Distribution of functional outcome [Time frame: 90 days]
  • Health-related quality of life (HRQoL) [Time frame: 90 days]
  • Neurological status [Time frame: 72±12 hours]
  • Early neurological improvement [Time frame: 72±12 hours]
  • Final infarct volume [Time frame: 24-72 hours]
  • Symptomatic intracranial hemorrhage (sICH) [Time frame: 7 days]
  • Any intracranial hemorrhage [Time frame: 7 days]
  • Malignant cerebral edema [Time frame: 7 days]
  • All-cause mortality [Time frame: 7 days]
  • All-cause mortality [Time frame: 90 days]
  • EVT-related adverse events [Time frame: 4 days]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 y;
  • Diagnosed as acute ischemic stroke;
  • Isolated medium distal vessel occlusion (i.e. an occlusion of the 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) confirmed by CT or MR Angiography;
  • Time from onset (or last-seen-well) to randomization < 24h;
  • Has not received intravenous thrombolysis and is considered unsuitable for it based on the treating clinician's assessment.
  • NIHSS ≥ 5, or NIHSS ≤ 4 with disabling deficit (e.g. severe aphasia, hemianopia, hemiplegia/loss of function in one side) or fluctuating symptoms at the time of randomization;
  • For patients within 6 h of onset: No visually apparent hypodensity is observed on non-contrast CT compared with the contralateral white matter, or no hyperintensity is seen on fluid-attenuated inversion recovery (FLAIR) imaging; For patients presenting 6-24 h after onset: A perfusion imaging-based ischemic core mismatch ratio >1.2 and an infarct core volume <50 mL are required;
  • Pre-stroke mRS ≤ 1；
  • Patient/Legally Authorized Representative has signed the Informed Consent form.

Exclusion criteria

  • Any evidence of intracranial hemorrhage on qualifying imaging;
  • Concurrent multiple (≥2) intracranial arterial occlusions;
  • Suspected cerebral vasculitis, septic embolism, or infective endocarditis as the cause of vessel occlusion;
  • Suspected arterial dissection;
  • Clinical assessment of conditions unsuitable for interventional therapy (e.g., severe contrast agent allergy or absolute contraindications to iodine contrast agent; severe renal insufficiency, glomerular filtration rate < 30ml/min or serum creatinine > 220μmol/L (2.5 mg/dl));
  • Unsuitable for arterial thrombolytic therapy (e.g., known history of hereditary or acquired hemorrhagic disease and/or platelet count <50×109/L; abnormal coagulation function (INR>1.7); oral anticoagulants were taken within 24 - 48 hours before onset within APTT > 3 times normal; recent medical history or clinical manifestations of brain tumors other than meningiomas);
  • Any terminal disease with life expectancy <1 year;
  • Pregnancy or lactation;
  • Concurrent participation in another investigational drug or device study that could interfere with the present trial;
  • Other circumstances that participation is not deemed appropriate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT07336927 · 2025(No.2695)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗