Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation (Mild-MT)

Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation: A Multicenter Prospective Registry

Explore the effectiveness and safety of emergency endovascular treatment in patients with mild ischemic stroke due to acute large vessel occlusion in the anterior circulation, identified through perfusion imaging.

Study Overview

• Status: Recruiting
• Conditions: Mild Stroke; Endovascular Treatment
• Intervention / Treatment: Procedure: EVT

Detailed Description

The purpose of this registry is to select patients with mild AIS caused by anterior circulation LVO with mismatched volume of the ischemic penumbra based on screen of cerebral perfusion imaging. This registry 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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenhuo Chen, MD; Phone Number: +8613806906089; Email: 13806906089@126.com
• Study Contact Backup: Name: Tingyu Yi, MD; Phone Number: +8615859635985; Email: siyuyufen@163.com

Study Locations

• China
  • Fujian
    • Zhangzhou, Fujian, China, 363000
      • Recruiting
      • Zhangzhou Municipal Hospital
      • Contact: Tingyu Yi, MD; Phone Number: 15859635985; Email: siyuyufen@163.com
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Recruiting
      • Gansu Provincial Hospital of Traditional Chinese Medicine
      • Contact: Ya Shao, MD; Phone Number: 18919810265; Email: shaoya20042001@126.com
  • Heilongjiang
    • Jiamusi, Heilongjiang, China, 154000
      • Recruiting
      • Jiamusi Central Hospital
      • Contact: Li-hua Xu, MD; Phone Number: 13846178333; Email: drxulihua@163.com
  • Jiangxi
    • Ganzhou, Jiangxi, China, 330000
      • Recruiting
      • Ganzhou People's Hospital
      • Contact: Guoyong Zeng, MD; Phone Number: 13507079530; Email: hsyygy@163.com
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Xiaobing Li, MD; Phone Number: 13970935284; Email: lxb0203208@126.com
  • Jilin
    • Songyuan, Jilin, China, 138000
      • Recruiting
      • Songyuan Jilin Oilfield Hospital
      • Contact: Dongsheng Ju; Phone Number: 13894158599; Email: judongsheng_1981@163.com
  • Liaoling
    • Shenyang, Liaoling, China
      • Recruiting
      • Shenyang First People's Hospital
      • Contact: Yi Sui, MD; Phone Number: 13998352587; Email: tjyiia@hotmail.com
  • Zhejiang
    • Lishui, Zhejiang, China, 310000
      • Recruiting
      • Lishui Central Hospital
      • Contact: Xueli Cai; Phone Number: 13967059836; Email: mailto:xueli_cai_official@126.com
    • Taizhou, Zhejiang, China, 310000
      • Recruiting
      • Taizhou First People's Hospital
      • Contact: Chenghua Xu; Phone Number: 15857655838; Email: samuel5098@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-80 years old;
2. Symptoms onset or last known well to randomization is within 24 hours.
3. 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) ;
4. Baseline NIHSS score <6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization);
5. ASPECTS score ≥6 based on Non-contrast CT (NCCT) before randomization;

Exclusion Criteria:

1. Premorbid Rankin Scale (mRS) score ≥ 1;
2. Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure;
3. 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);
4. Poorly controlled hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg);
5. Baseline blood glucose <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L);
6. 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;
7. Seizures at stroke onset or during the course, hard to accurately judge the baseline NIHSS score;
8. Female who is known to be pregnant, lactation, or tested positive for pregnancy at time of admission;
9. Currently participating in another investigational drug study or medical device treatments that may interfere with the results of this study;
10. Evidence of intracranial hemorrhage on CT/MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hemorrhage;
11. Significant midline displacement, hernia of brain, or ventricular mass effect with midline displacement confirmed on CT/MRI;
12. Anticipated impossibility to complete endovascular treatment, such as vascular tortuosity, severe vascular wall calcification, etc.;
13. Aortic dissection;
14. 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;
15. Suspected or confirmed occluded artery is non-acute occlusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The operator will choose the optimal endovascular treatment strategy and device based on the patient's condition and clinical experience. This may include, but is not limited to, stent retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, etc. The endovascular treatment plan and relevant time points will be accurately recorded. The patient will receive the best medical treatment according to current local clinical research standards during and after the procedure.	Procedure: EVT; 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 Names: Experimental
No Intervention: Control Group; Patients will receive the best medical treatment according to local clinical research standards, including antiplatelet agents, anticoagulants, thrombolysis, etc., excluding any endovascular treatment. In the event of disease progression defined as neurological deterioration leading to an increase in NIHSS ≥4 points and excluding non-stroke factors within 24 hours, remedial endovascular treatment may be taken, including but not limited to stent retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of excellent outcome	mRS score 0-1	90±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of good outcome	mRS score 0-2	90±7 days
mRS shift	distribution of mRS scores	90±7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of symptomatic intracranial hemorrhage	According to the Heidelberg criteria	Within 48 hours
Rate of early neurological deterioration	An increase in NIHSS≥4 or an increase of ≥2 in any individual item	Within 7 days
Mortality	Death	90±7 days

Collaborators and Investigators

• Sponsor: Wen-huo Chen
• Investigators: Principal Investigator: Tingyu Yi, MD, Zhangzhou Affiliated Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): September 11, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: endovascular treatment; mild stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: Mild-MT registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No