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

Endovascular Treatment Clinical Trial

— Mild-MT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06464731
• Other study ID #: Mild-MT registry
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Zhangzhou Municipal Hospital
• Contact: Wenhuo Chen, MD
• Phone: +8613806906089
• Email: 13806906089[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: September 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endovascular Treatment
• Ischemic Stroke
• Mild Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Ganzhou People's Hospital	Ganzhou	Jiangxi
China	Jiamusi Central Hospital	Jiamusi	Heilongjiang
China	Gansu Provincial Hospital of Traditional Chinese Medicine	Lanzhou	Gansu
China	Lishui Central Hospital	Lishui	Zhejiang
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Shenyang First People's Hospital	Shenyang	Liaoling
China	Songyuan Jilin Oilfield Hospital	Songyuan	Jilin
China	Taizhou First People's Hospital	Taizhou	Zhejiang
China	Zhangzhou Municipal Hospital	Zhangzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Wen-huo Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The rate of symptomatic intracranial hemorrhage	According to the Heidelberg criteria	Within 48 hours
Other	Rate of early neurological deterioration	An increase in NIHSS=4 or an increase of =2 in any individual item	Within 7 days
Other	Mortality	Death	90±7 days
Primary	The rate of excellent outcome	mRS score 0-1	90±7 days
Secondary	The rate of good outcome	mRS score 0-2	90±7 days
Secondary	mRS shift	distribution of mRS scores	90±7 days