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

NCT06179017 | Active Not Recruiting DMC

• 1 other identifier: MILD-MT
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Mild Stroke; Acute Ischemic Stroke; Perfusion Imaging; Endovascular Treatment

Keywords

MILD-MT; Mild stroke

Outcome Measures

Primary Outcomes (1)

• the rate of excellent outcome at () days

  mRS score 0-1

  90±7 days

Secondary Outcomes (2)

• mRS shift

  90±7 days

• proportion of subjects with good neurological function prognosis

  90±7 days

Other Outcomes (3)

• the rate of symptomatic intracranial hemorrhage

  within 48 hours

• rate of early neurological deterioration

  within 7 days

• mortality

  90±7 days

Study Arms (2)

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.

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.

Other: Control group:best medical treatment

Interventions

Experimental group:Intervention Group OTHER

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.

Intervention Group:Endovascular treatment

Control group:best medical treatment OTHER

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.

Control group: Best medical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Changhai Hospital: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Zhangzhou Municipal Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Related Publications (2)

• 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.

  PMID: 35599458 BACKGROUND

• 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.

  PMID: 41974578 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wenhuo Chen, MD

  Fujian Medical University Union Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Endpoint-blined
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Intervention group: Endovascular treatment Control group:Best medical treatment

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 21, 2023
• Study Start: February 7, 2024
• Primary Completion: January 16, 2026
• Study Completion: April 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)