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.
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
- Conditions the study is for
- Mild Stroke, Acute Ischemic Stroke, Endovascular Treatment
- 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.
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 group | Role | What they receive |
|---|---|---|
| Intervention Group:Endovascular treatment | Experimental | Interventionist 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 treatment | Placebo comparator | 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.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.
the rate of excellent outcome at () days
mRS score 0-1
Measured: 90±7 days
Secondary outcomes (2)
mRS shift
distribution of mRS scores
Measured: 90±7 days
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.
- First posted21 Dec 2023
- Study start7 Feb 2024
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild StrokeStudies 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
- Model description
- Intervention group: Endovascular treatment Control group:Best medical treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhangzhou Municipal Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, The Affiliated Hospital Of Guizhou Medical University
- Responsible party
- Principal investigator, Tingyu-Yi, Zhangzhou Municipal Hospital
- Investigators
- Wenhuo Chen, MD, Study director, Fujian Medical University Union Hospital
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 35599458Liu 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 42929671Wu 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion:a Multicenter Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06179017
- Acronym / sponsor ID
- MILD-MT
- Keywords
- MILD-MT, Mild stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Zhangzhou Municipal HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, The Affiliated Hospital Of Guizhou Medical University
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 21 Dec 2023 (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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group: Endovascular treatment Control group:Best medical treatment
| Arm | Type | Receives |
|---|---|---|
| Intervention Group:Endovascular treatment | Experimental | Other: Experimental group:Intervention GroupInterventionist 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. |
| Control group: Best medical treatment | Placebo comparator | Other: Control group:best medical treatmentPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Experimental group:Intervention GroupIntervention 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. | Other | Intervention Group:Endovascular treatment |
| Control group:best medical treatmentBest 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. | Other | Control group: Best medical treatment |
Primary outcome
the rate of excellent outcome at () days
Time frame: 90±7 days
mRS score 0-1
2 secondary outcomes
mRS shift
Time frame: 90±7 days
proportion of subjects with good neurological function prognosis
Time frame: 90±7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 35599458Sarraj 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.
- Derived from this study: PubMed 42929671Liu 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.
- Derived from this study: PubMed 41974578Wu 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Wenhuo Chen, MD study director
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
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.