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Mild StrokeNCT06179017

Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion

A study testing Experimental group:Intervention Group in people with Mild Stroke and Acute Ischemic Stroke, run by Zhangzhou Municipal Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Exploring the Efficacy and Safety of Emergent Endovascular Treatment in Patients with Mild Ischemic Stroke Caused by Acute Anterior Circulation Large Vessel Occlusion based on Perfusion Imaging Screening Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Experimental group:Intervention Group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteChina
Study dates
7 Feb 2024to 16 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 years old;
  • Symptoms onset or last known well to randomization is within 24 hours.
  • Clinical diagnosis of acute ischemic stroke due to anterior circulation intracranial large vessel occlusion (LVO) (including intracranial internal carotid artery [ICA], middle cerebral artery [MCA] M1 segment, MCA M2 segment, with or without ipsilateral extracranial ICA occlusion) confirmed on Computerized tomography angiography (CTA) or Magnetic resonance imaging angiography (MRA) ;
  • Baseline NIHSS score <6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization);
  • ASPECTS score ≥6 based on Non-contrast CT (NCCT) before randomization, and computerized tomography perfusion (CTP) or magnetic resonance imaging perfusion (MRP) imaging presented infarct core volume (relative cerebral blood flow (rCBF) <30%/DWI-ADC<620) ≤50ml, and mismatch volume (Tmax>6 seconds volume - rCBF <30% /DWI-ADC<620) ≥50mL;
  • The patient or their legal representatives voluntarilysigned the informed consent form.
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  • Clinical Exclusion Criteria
  • Premorbid Rankin Scale (mRS) score ≥ 1;
  • Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure;
  • Patient has severe or fatal co-morbidities that could interfere with outcome assessments and follow-up (such as malignant tumor, severe heart failure, or renal failure, or life expectancy less than 6 months);
  • Poorly controlled hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg);
  • Baseline blood glucose <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L);
  • Known bleeding tendencies, including but not limited to platelet count <100×109/L; received heparin treatment within 48 hours with an activated partial thromboplastin time (APTT) ≥35s; recent oral anticoagulant therapy with international normalized ratio (INR) >3; Note: Patients without a history of coagulation abnormalities or without suspicion of coagulation abnormalities do not need to wait for laboratory test results before enrollment;
  • Seizures at stroke onset or during the course, hard to accurately judge the baseline NIHSS score;
  • Female who is known to be pregnant, lactation, or tested positive for pregnancy at time of admission;
  • Currently participating in another investigational drug study or medical device treatments that may interfere with the results of this study;
  • Other conditions deemed unsuitable for participation, in the opinion of the investigator, or that may pose significant risks to the patient if participating the study.
  • Imaging Exclusion Criteria:
  • Evidence of intracranial hemorrhage on CT/MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hemorrhage;
  • Significant midline displacement, hernia of brain, or ventricular mass effect with midline displacement confirmed on CT/MRI;
  • Anticipated impossibility to complete endovascular treatment, such as vascular tortuosity, severe vascular wall calcification, etc.;
  • Aortic dissection;
  • Multiple intracranial large vessel occlusions confirmed by CTA or MRA, unable to clearly identify the symptomatic vessel, such as bilateral MCA occlusions or occlusions involving both the MCA and basilar artery;
  • Suspected or confirmed occluded artery is non-acute occlusion.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

Other trials in China

About this study

Official title: Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion:a Multicenter Randomized Controlled Trail

Exploring the Efficacy and Safety of Emergent Endovascular Treatment in Patients with Mild Ischemic Stroke Caused by Acute Anterior Circulation Large Vessel Occlusion based on Perfusion Imaging Screening

Read the detailed description

This study aims to select suitable patients with mild AIS caused by anterior circulation LVO with mismatch volume of the ischemic penumbra based on screen of cerebral perfusion imaging. It is a prospective, multicenter, endpoint-blinded, randomized controlled trial design, and aim to explore the efficacy and safety of EVT for mild AIS patients with anterior circulation large vessel occlusion within 24 hours of onset.

Being tested
Experimental group:Intervention Group, Control group:best medical treatment
Keywords
MILD-MT, Mild stroke
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental group:Intervention GroupOther

    Intervention Group:Interventionist choose the optimal endovascular treatment (EVT) strategy and device based on the patient's condition and local guidelines. The patient will receive the best medical treatment according to the local guidelines.

  • Control group:best medical treatmentOther

    Best medical treatment:Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.

Study groups in NCT06179017
Study groupRoleWhat they receive
Intervention Group:Endovascular treatmentExperimentalInterventionist choose the optimal EVT strategy and device based on the patient's condition and local guidelines. This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on. The EVT regimen and relevant time points will be accurately recorded. The patient will receive the best medical treatment according to the local guidelines.
Receives: Other: Experimental group:Intervention Group
Control group: Best medical treatmentPlacebo comparatorPatients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on.
Receives: Other: Control group:best medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the rate of excellent outcome at () days

    mRS score 0-1

    Measured: 90±7 days

Secondary outcomes (2)
  1. mRS shift

    distribution of mRS scores

    Measured: 90±7 days

  2. proportion of subjects with good neurological function prognosis

    mRS score 0-2

    Measured: 90±7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2023
  2. Study start7 Feb 2024
  3. Primary completion16 Jan 2026
  4. Study completion16 Jan 2026

Resources

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
Model description
Intervention group: Endovascular treatment Control group:Best medical treatment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06179017
Sponsor's protocol ID
MILD-MT
Status last verified
Sep 2026
First submitted
2 Dec 2023
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sarraj A, Albers GW, Blasco J, Arenillas JF, Ribo M, Hassan AE, de la Ossa NP, Wu TY, Cardona Portela P, Abraham MG, Chen M, Maali L, Kleinig TJ, Cordato D, Wallace AN, Schaafsma JD, Sangha N, Gibson DP, Blackburn SL, De Lera Alfonso M, Pujara D, Shaker F, McCullough-Hicks ME, Moreno Negrete JL, Renu A, Beharry J, Cappelen-Smith C, Rodriguez-Esparragoza L, Olive-Gadea M, Requena M, Almaghrabi T, Mendes Pereira V, Sitton C, Martin-Schild S, Song S, Ma H, Churilov L, Mitchell PJ, Parsons MW, Furlan A, Grotta JC, Donnan GA, Davis SM, Campbell BCV; PERFECT-MILD Collaborators. Thrombectomy versus Medical Management in Mild Strokes due to Large Vessel Occlusion: Exploratory Analysis from the EXTEND-IA Trials and a Pooled International Cohort. Ann Neurol. 2022 Sep;92(3):364-378. doi: 10.1002/ana.26418. Epub 2022 Jul 25.

    PubMed 35599458
  • Liu J, Yi T, Xing P, Wu M, Zhang L, Zheng T, Huang M, Wu Y, Wang H, Zeng G, Li J, Peng Y, Zhu Y, Fang Y, Cai X, Luo J, Lei Y, Qin H, Fang P, Tang Y, Yuan G, Wang E, He X, Lu X, Li Z, Lei B, Cao H, Yang X, Xu C, Shang M, Anderson CS, Ren Z, Yang P, Chen W; MILD-MT Investigators. Trial of Endovascular Therapy for Mild Stroke with Large-Vessel Occlusion. N Engl J Med. 2026 Oct 23. doi: 10.1056/NEJMoa2609149. Online ahead of print.

    PubMed 42929671
  • Wu M, Yi T, Xing P, Wu YM, Lin DL, Lin X, Huang MZ, Ren Z, Liu J, Yang P, Zheng T, Zhang M, Wang H, Chen W. Endovascular treatment for MILD ischaemic stroke with acute anterior circulation large vessel occlusion: a multicentre, prospective, randomised, clinical trial (MILD-MT) protocol. Stroke Vasc Neurol. 2026 Apr 13:svn-2025-004832. doi: 10.1136/svn-2025-004832. Online ahead of print.

    PubMed 41974578

Questions about this trial

What is this clinical trial studying?

A study testing Experimental group:Intervention Group in people with Mild Stroke and Acute Ischemic Stroke, run by Zhangzhou Municipal Hospital 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 24 inclusion and 0 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: finished, as of the sponsor's last update on 24 Sep 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the rate of excellent outcome at () days (time frame: 90±7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06179017, which also lists 3 linked publications.

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 24 Sep 2026.

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