Clinical trial NCT06464731: Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation
Official title: Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation: A Multicenter Prospective Registry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endovascular Treatment
Mild Stroke
Keywords: endovascular treatment
mild stroke
Lead sponsor: Zhangzhou Municipal Hospital
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The rate of excellent outcome
timeFrame: 90±7 days
Secondary outcomes:
measure: The rate of good outcome
timeFrame: 90±7 days
measure: mRS shift
timeFrame: 90±7 days
Other outcomes:
measure: The rate of symptomatic intracranial hemorrhage
timeFrame: Within 48 hours
measure: Rate of early neurological deterioration
timeFrame: Within 7 days
measure: Mortality
timeFrame: 90±7 days
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital
state: Fujian
city: Lanzhou
country: China
facility: Gansu Provincial Hospital of Traditional Chinese Medicine
state: Gansu
city: Jiamusi
country: China
facility: Jiamusi Central Hospital
state: Heilongjiang
city: Ganzhou
country: China
facility: Ganzhou People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Songyuan
country: China
facility: Songyuan Jilin Oilfield Hospital
state: Jilin
city: Shenyang
country: China
facility: Shenyang First People's Hospital
state: Liaoling
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: Zhangzhou Affiliated Hospital
name: Tingyu Yi, MD
role: PRINCIPAL_INVESTIGATOR
References: