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

Not Applicable

Recruiting

• Conditions: Mild Stroke; Endovascular Treatment
• Interventions: Procedure: EVT

• Registration Number: NCT06464731
• Lead Sponsor: Wen-huo Chen

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.

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 Timeline

• Study Start: 2017-01-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-09-11
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	EVT	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.

Primary Outcome Measures

Name	Time	Method
The rate of excellent outcome	90±7 days	mRS score 0-1

Secondary Outcome Measures

Name	Time	Method
The rate of good outcome	90±7 days	mRS score 0-2
mRS shift	90±7 days	distribution of mRS scores

Trial Locations

Locations (9)

Songyuan Jilin Oilfield Hospital; 🇨🇳 Songyuan, Jilin, China

Zhangzhou Municipal Hospital; 🇨🇳 Zhangzhou, Fujian, China

Ganzhou People's Hospital; 🇨🇳 Ganzhou, Jiangxi, China

Jiamusi Central Hospital; 🇨🇳 Jiamusi, Heilongjiang, China

Gansu Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Lanzhou, Gansu, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Shenyang First People's Hospital; 🇨🇳 Shenyang, Liaoling, China

Lishui Central Hospital; 🇨🇳 Lishui, Zhejiang, China

Taizhou First People's Hospital; 🇨🇳 Taizhou, Zhejiang, China