Acute Ischemic Stroke Due to Medium-vessel-occlusionIAT-MeVONCT07336927
IAT-MeVO Trial Domain Within the ACT-GLOBAL Adaptive Platform Trial
A study testing Endovascular Treatment in people with Acute Ischemic Stroke Due to Medium-vessel-occlusion, run by Bo Wu at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke Due to Medium-vessel-occlusion
- What is being tested?
- Endovascular Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Bo Wu, +8618980602142, dr.bowu@hotmail.com
Fayun Hu, Dr., +8615902861270, hufayun2006@163.com
About this study
Official title: 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.
- Being tested
- Endovascular Treatment
- Keywords
- Acute Ischemic Stroke, Medium vessel occlusion, Intra-arterial thrombolysis, Endovascular therapy, Randomized clinical trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Treatment Group | Experimental | Recieving intra-arterial thrombolysis-based EVT after randomization. Receives: Procedure: Endovascular Treatment |
| Best Medical Management Group | No intervention | Upon enrollment, patients will receive best medical management alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 days
Secondary outcomes (12)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 72±12 hours
Final infarct volume
Final infarct size based on CT or MRI
Measured: 24-72 hours
Symptomatic intracranial hemorrhage (sICH)
sICH defined by SIST-MOST criteria
Measured: 7 days
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.
Measured: 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
Measured: 7 days
All-cause mortality
Death
Measured: 7 days
All-cause mortality
Death
Measured: 90 days
EVT-related adverse events
adverse events post-EVT
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke Due to Medium-vessel-occlusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Wu
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Mianyang Central Hospital, Chengdu First People's Hospital, Sichuan Provincial People's Hospital, Deyang People's Hospital, Suining Central Hospital, The Second People's Hospital of Chengdu
- Responsible party
- Sponsor-investigator, Bo Wu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336927
- Sponsor's protocol ID
- 2025(No.2695)
- Acronym
- IAT-MeVO
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endovascular Therapy With Intra-Arterial Thrombolysis for Medium Vessel Occlusion Stroke--the IAT-MeVO Trial
- ClinicalTrials.gov ID
- NCT07336927
- Acronym / sponsor ID
- IAT-MeVO / 2025(No.2695)
- Keywords
- Acute Ischemic Stroke, Medium vessel occlusion, Intra-arterial thrombolysis, Endovascular therapy, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 614 participants (estimated)
- Lead sponsor
- Bo WuUniversity, hospital or other
- Collaborators
- West China Hospital, Mianyang Central Hospital, Chengdu First People's Hospital, Sichuan Provincial People's Hospital, Deyang People's Hospital, Suining Central Hospital, The Second People's Hospital of Chengdu
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Treatment Group | Experimental | Procedure: Endovascular TreatmentRecieving intra-arterial thrombolysis-based EVT after randomization. |
| Best Medical Management Group | No intervention | –Upon enrollment, patients will receive best medical management alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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));
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular TreatmentPatients 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. | Procedure or surgery | Endovascular Treatment Group |
Primary outcome
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).
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Treatment in people with Acute Ischemic Stroke Due to Medium-vessel-occlusion, run by Bo Wu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Wu, MD, PhD (+8618980602142, dr.bowu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent functional outcome (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.