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NCT Number: NCT07336927

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

endovascular treatment

Procedure

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, maximum 12.5 mg

*No restrictions will be placed on the choice of aspiration catheters or stent retrievers used in this study.

Primary outcomes

  1. Excellent functional outcome

    Time frame: 90 days

    The proportion of patients with an modified Rankin Scale (mRS) score of 0-1. The mRS is a clinician-reported measure of global disability widely used to assess outcomes in patients with stroke and other neurological disorders. It ranges from 0 (no symptoms) to 6 (death).

Secondary outcomes

  1. Good functional outcome

    Time frame: 90 days

    The proportion of patients with an modified Rankin Scale (mRS) score of 0-2. The mRS is a clinician-reported measure of global disability widely used to assess outcomes in patients with stroke and other neurological disorders. It ranges from 0 (no symptoms) to 6 (death).

  2. Distribution of functional outcome

    Time frame: 90 days

    The modified Rankin Scale (mRS) score at 90 days and the utility weighted mRS. The mRS is a clinician-reported measure of global disability widely used to assess outcomes in patients with stroke and other neurological disorders. It ranges from 0 (no symptoms) to 6 (death).

  3. Health-related quality of life (HRQoL)

    Time frame: 90 days

    Quality of life measured using EQ-5D-5L.The EuroQol 5-Dimension 5-Level instrument (EQ-5D-5L) is a generic, preference-based measure of health-related quality of life. It generates two primary scores: 1) a utility index score (typically ranging from -0.573 to 1.00, depending on the value set, where 1 represents 'full health'), and 2) a self-rated Visual Analog Scale (EQ-VAS) score (ranging from 0 to 100). For both scores, a higher value indicates a better health outcome.

  4. Neurological status

    Time frame: 72±12 hours

    Neurological status measured by National Institutes of Health Stroke Scale (NIHSS) score. The National Institutes of Health Stroke Scale (NIHSS) is a standardized 15-item neurologic examination tool used to quantify the severity of acute cerebral infarction. Scores range from 0 to 42, with higher scores indicating more severe neurological deficit.

  5. Early neurological improvement

    Time frame: 72±12 hours

    Achieving an NIHSS score of 0-1 or a decrease of ≥4 points from the baseline NIHSS score. The National Institutes of Health Stroke Scale (NIHSS) is a standardized 15-item neurologic examination tool used to quantify the severity of acute cerebral infarction. Scores range from 0 to 42, with higher scores indicating more severe neurological deficit.

  6. Final infarct volume

    Time frame: 24-72 hours

    Final infarct size based on CT or MRI

  7. Symptomatic intracranial hemorrhage (sICH)

    Time frame: 7 days

    sICH defined by SIST-MOST criteria

  8. Any intracranial hemorrhage

    Time frame: 7 days

    Any intracranial hemorrhage was a key safety outcome, encompassing any acute bleeding within the cranial cavity. All suspected events were confirmed by follow-up CT or MRI scans.

  9. Malignant cerebral edema

    Time frame: 7 days

    The incidence of malignant edema, adjudicated by the central imaging core lab according to follow-up imaging and medical history

  10. All-cause mortality

    Time frame: 7 days

    Death

  11. All-cause mortality

    Time frame: 90 days

    Death

  12. EVT-related adverse events

    Time frame: 4 days

    adverse events post-EVT

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Wu, MD, PhD

CONTACT

[email protected]

+8618980602142

Sponsors and collaborators

Lead sponsor

Bo Wu

Other

Collaborators

  • Chengdu First People's Hospital
  • Deyang People's Hospital
  • Mianyang Central Hospital
  • Sichuan Provincial People's Hospital
  • Suining Central Hospital
  • The Second People's Hospital of Chengdu
  • West China Hospital

Registry information

Official study title

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

Acronym: IAT-MeVO

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 13, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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