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

NCT06464731 | Recruiting DMC

• 1 other identifier: Mild-MT registry
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Endovascular Treatment; Mild Stroke

Keywords

endovascular treatment; mild stroke

Outcome Measures

Primary Outcomes (1)

• The rate of excellent outcome

  mRS score 0-1

  90±7 days

Secondary Outcomes (2)

• The rate of good outcome

  90±7 days

• mRS shift

  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)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

EVT PROCEDURE

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.

Also known as: Experimental

Experimental Group

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;

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;
• 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.

Sponsors & Collaborators

• Wen-huo Chen: lead

Study Sites (9)

Zhangzhou Municipal Hospital

Zhangzhou, Fujian, 363000, China

RECRUITING

Gansu Provincial Hospital of Traditional Chinese Medicine

Lanzhou, Gansu, 730050, China

RECRUITING

Jiamusi Central Hospital

Jiamusi, Heilongjiang, 154000, China

RECRUITING

Ganzhou People's Hospital

Ganzhou, Jiangxi, 330000, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Songyuan Jilin Oilfield Hospital

Songyuan, Jilin, 138000, China

RECRUITING

Shenyang First People's Hospital

Shenyang, Liaoling, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, 310000, China

RECRUITING

Taizhou First People's Hospital

Taizhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• Tingyu Yi, MD

  Zhangzhou Affiliated Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhuo Chen, MD

CONTACT

+8613806906089; 13806906089@126.com

Tingyu Yi, MD

CONTACT

+8615859635985; siyuyufen@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: January 1, 2017
• Primary Completion: September 11, 2024
• Study Completion: December 30, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)