Emergency endovascular treatment for mild ischemic stroke

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

This study is testing if a special emergency treatment can help people with mild strokes caused by blocked blood vessels in the brain feel better when given within 24 hours of their symptoms starting.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhangzhou Municipal Hospital (Academic / other)
• Locations: 9 sites (Zhangzhou, Fujian and 8 other locations)
• Trial ID: NCT06464731 on ClinicalTrials.gov

What this trial studies

This study explores the effectiveness and safety of emergency endovascular treatment (EVT) for patients experiencing mild ischemic stroke caused by acute large vessel occlusion in the anterior circulation. Patients are selected based on cerebral perfusion imaging to identify those with a mismatch in ischemic penumbra volume. The study aims to evaluate the efficacy of EVT within 24 hours of symptom onset for this specific patient population. The goal is to determine if EVT can improve outcomes for patients with mild strokes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have experienced mild ischemic strokes due to anterior circulation large vessel occlusion within 24 hours of symptom onset.

Not a fit: Patients with severe co-morbidities or those with a premorbid Rankin Scale score of 1 or higher may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with mild ischemic strokes.

How similar studies have performed: Other studies have shown promise in using endovascular treatment for acute ischemic strokes, but this specific approach for mild strokes is relatively novel.

Eligibility criteria

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.

Where this trial is running

Zhangzhou, Fujian and 8 other locations

• Zhangzhou Municipal Hospital — Zhangzhou, Fujian, China (Recruiting)
• Gansu Provincial Hospital of Traditional Chinese Medicine — Lanzhou, Gansu, China (Recruiting)
• Jiamusi Central Hospital — Jiamusi, Heilongjiang, China (Recruiting)
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Songyuan Jilin Oilfield Hospital — Songyuan, Jilin, China (Recruiting)
• Shenyang First People's Hospital — Shenyang, Liaoling, China (Recruiting)
• Lishui Central Hospital — Lishui, Zhejiang, China (Recruiting)
• Taizhou First People's Hospital — Taizhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Tingyu Yi, MD — Zhangzhou Affiliated Hospital
• Study coordinator: Wenhuo Chen, MD

Conditions Endovascular Treatment; Mild Stroke; endovascular treatment; mild stroke