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
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2017-01-01
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Wen-huo Chen
OTHER
Responsible Party
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Wen-huo Chen
Professor
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
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu, China
Jiamusi Central Hospital
Jiamusi, Heilongjiang, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Songyuan Jilin Oilfield Hospital
Songyuan, Jilin, China
Shenyang First People's Hospital
Shenyang, Liaoling, China
Lishui Central Hospital
Lishui, Zhejiang, China
Taizhou First People's Hospital
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Mild-MT registry
Identifier Type: -
Identifier Source: org_study_id
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