NCT07336927

Brief 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 medium vessel occlusion (MeVO) who are ineligible for intravenous thrombolysis (IV) within 24 h of onset.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
614

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Dec 2030

Study Start

First participant enrolled

January 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 15, 2026

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

January 4, 2026

Last Update Submit

January 13, 2026

Conditions

Acute Ischemic Stroke Due to Medium-vessel-occlusion

Keywords

Acute Ischemic StrokeMedium vessel occlusionIntra-arterial thrombolysisEndovascular therapyRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Good functional outcome

    90 days

  • Distribution of functional outcome

    90 days

  • Health-related quality of life (HRQoL)

    90 days

  • Neurological status

    72±12 hours

  • Early neurological improvement

    72±12 hours

  • +7 more secondary outcomes

Study Arms (2)

Endovascular Treatment Group

EXPERIMENTAL

Recieving intra-arterial thrombolysis-based EVT after randomization.

Procedure: Endovascular Treatment

Best Medical Management Group

NO INTERVENTION

Upon enrollment, patients will receive best medical management alone.

Interventions

Endovascular TreatmentPROCEDURE

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.

Endovascular Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Bo Wu, MD, PhD

CONTACT

+8618980602142dr.bowu@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Open-label trial; only the outcome assessors and partial data analysts will be masked to treatment allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician/Clinical Professor

Study Record Dates

First Submitted

January 4, 2026

First Posted

January 13, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

January 15, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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.

Locations

CN(1)