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

NCT ID: NCT06464731

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Endovascular Treatment Mild Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

EVT

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Experimental

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wen-huo Chen

OTHER

Sponsor Role lead

Responsible Party

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Wen-huo Chen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tingyu Yi, MD

Role: PRINCIPAL_INVESTIGATOR

Zhangzhou Affiliated Hospital

Locations

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Zhangzhou Municipal Hospital

Zhangzhou, Fujian, China

Site Status RECRUITING

Gansu Provincial Hospital of Traditional Chinese Medicine

Lanzhou, Gansu, China

Site Status RECRUITING

Jiamusi Central Hospital

Jiamusi, Heilongjiang, China

Site Status RECRUITING

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Songyuan Jilin Oilfield Hospital

Songyuan, Jilin, China

Site Status RECRUITING

Shenyang First People's Hospital

Shenyang, Liaoling, China

Site Status RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, China

Site Status RECRUITING

Taizhou First People's Hospital

Taizhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenhuo Chen, MD

Role: CONTACT

+8613806906089

Tingyu Yi, MD

Role: CONTACT

+8615859635985

Facility Contacts

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Tingyu Yi, MD

Role: primary

15859635985

Ya Shao, MD

Role: primary

18919810265

Li-hua Xu, MD

Role: primary

13846178333

Guoyong Zeng, MD

Role: primary

13507079530

Xiaobing Li, MD

Role: primary

13970935284

Dongsheng Ju

Role: primary

13894158599

Yi Sui, MD

Role: primary

13998352587

Xueli Cai

Role: primary

Chenghua Xu

Role: primary

15857655838

Other Identifiers

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Mild-MT registry

Identifier Type: -

Identifier Source: org_study_id

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