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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke Due to Medium-vessel-occlusion
• Intervention / Treatment: Procedure: Endovascular Treatment

• Study Type: Interventional
• Enrollment (Estimated): 614
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Wu, MD, PhD; Phone Number: +8618980602142; Email: dr.bowu@hotmail.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
      • Contact: Bo Wu; Phone Number: +8618980602142; Email: dr.bowu@hotmail.com
      • Contact: Fayun Hu, Dr.; Phone Number: +8615902861270; Email: hufayun2006@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 y;
2. Diagnosed as acute ischemic stroke;
3. 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;
4. Time from onset (or last-seen-well) to randomization < 24h;
5. Has not received intravenous thrombolysis and is considered unsuitable for it based on the treating clinician's assessment.
6. 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;
7. 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;
8. Pre-stroke mRS ≤ 1；
9. Patient/Legally Authorized Representative has signed the Informed Consent form.

Exclusion Criteria:

1. Any evidence of intracranial hemorrhage on qualifying imaging;
2. Concurrent multiple (≥2) intracranial arterial occlusions;
3. Suspected cerebral vasculitis, septic embolism, or infective endocarditis as the cause of vessel occlusion;
4. Suspected arterial dissection;
5. 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));
6. 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);
7. Any terminal disease with life expectancy <1 year;
8. Pregnancy or lactation;
9. Concurrent participation in another investigational drug or device study that could interfere with the present trial;
10. Other circumstances that participation is not deemed appropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovascular Treatment Group; Recieving intra-arterial thrombolysis-based EVT after randomization.	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, maximum 12.5 mg *No restrictions will be placed on the choice of aspiration catheters or stent retrievers used in this study.
No Intervention: Best Medical Management Group; Upon enrollment, patients will receive best medical management alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excellent functional outcome	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).	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final infarct volume	Final infarct size based on CT or MRI	24-72 hours
Symptomatic intracranial hemorrhage (sICH)	sICH defined by SIST-MOST criteria	7 days
Malignant cerebral edema	The incidence of malignant edema, adjudicated by the central imaging core lab according to follow-up imaging and medical history	7 days
All-cause mortality	Death	7 days
All-cause mortality	Death	90 days
EVT-related adverse events	adverse events post-EVT	4 days
Good functional outcome	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).	90 days
Distribution of functional outcome	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).	90 days
Health-related quality of life (HRQoL)	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.	90 days
Neurological status	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.	72±12 hours
Early neurological improvement	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.	72±12 hours
Any intracranial hemorrhage	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.	7 days

Collaborators and Investigators

• Sponsor: Bo Wu
• Collaborators: West China Hospital; Sichuan Provincial People's Hospital; Mianyang Central Hospital; Chengdu First People's Hospital; Suining Central Hospital; Deyang People's Hospital; The Second People's Hospital of Chengdu

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 4, 2026
• First Posted (Estimated): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Acute Ischemic Stroke; Endovascular therapy; Intra-arterial thrombolysis; Medium vessel occlusion
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2025(No.2695)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study will include individual information from multicenter and multination. To protect the participants' privacy and follow the guidelines of other center or nations' ethical committee, we don't provide or share IPD with other reasearchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No