Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion

Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion：a Multicenter Randomized Controlled Trail

Exploring the Efficacy and Safety of Emergent Endovascular Treatment in Patients with Mild Ischemic Stroke Caused by Acute Anterior Circulation Large Vessel Occlusion based on Perfusion Imaging Screening

Study Overview

• Status: Not yet recruiting
• Conditions: Endovascular Treatment
• Intervention / Treatment: Other: Experimental group:Intervention Group; Other: Control group:best medical treatment

Detailed Description

This study aims to select suitable patients with mild AIS caused by anterior circulation LVO with mismatch volume of the ischemic penumbra based on screen of cerebral perfusion imaging. It is a prospective, multicenter, endpoint-blinded, randomized controlled trial design, and aim to explore the efficacy and safety of EVT for mild AIS patients with anterior circulation large vessel occlusion within 24 hours of onset.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenhuo Chen, MD; Phone Number: +8613806906089; Email: 13806906089@126.com
• Study Contact Backup: Name: Tingyu Yi, MD; Phone Number: +8615859635985; Email: siyuyufen@163.com

Study Locations

• China
  • Fujian
    • Zhangzhou, Fujian, China, 363000
      • Zhangzhou Municipal Hospital
      • Contact: Wen-huo Chen, MD; Phone Number: 13806906089; Email: 13806906089@126.com
      • Principal Investigator: Pengfei Yang, MD
      • Principal Investigator: Zeguang Ren, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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, and computerized tomography perfusion (CTP) or magnetic resonance imaging perfusion (MRP) imaging presented infarct core volume (relative cerebral blood flow (rCBF) <30%/DWI-ADC<620) ≤50ml, and mismatch volume (Tmax>6 seconds volume - rCBF <30% /DWI-ADC<620) ≥50mL;
6. The patient or their legal representatives voluntarilysigned the informed consent form.

Clinical 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. Other conditions deemed unsuitable for participation, in the opinion of the investigator, or that may pose significant risks to the patient if participating the study.

Imaging Exclusion Criteria:

1. Evidence of intracranial hemorrhage on CT/MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hemorrhage;
2. Significant midline displacement, hernia of brain, or ventricular mass effect with midline displacement confirmed on CT/MRI;
3. Anticipated impossibility to complete endovascular treatment, such as vascular tortuosity, severe vascular wall calcification, etc.;
4. Aortic dissection;
5. 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;
6. Suspected or confirmed occluded artery is non-acute occlusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group:Endovascular treatment; 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: Experimental group:Intervention Group; Intervention Group:Interventionist choose the optimal endovascular treatment (EVT) strategy and device based on the patient's condition and local guidelines. The patient will receive the best medical treatment according to the local guidelines.
Placebo Comparator: Control group: Best medical treatment; Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on.	Other: Control group:best medical treatment; Best medical treatment:Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of excellent outcome at () days	mRS score 0-1	90±7 days and 365±30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS shift	distribution of mRS scores	90±7 days and 365±30 days
proportion of subjects with good neurological function prognosis	mRS score 0-2	90±7 days and 365±30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of symptomatic intracranial hemorrhage	according to the Heidelberg criteria	within 48 hours
rate of early neurological deterioration	an increase in NIHSS≥4 or an increase of ≥2 in any individual item	within 7 days
mortality	death	90±7 days and 365±30 days

Collaborators and Investigators

• Sponsor: Zhangzhou Municipal Hospital
• Collaborators: Changhai Hospital; The Affiliated Hospital Of Guizhou Medical University
• Investigators: Study Director: Wenhuo Chen, MD, Zhangzhou Municipal Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Estimated): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Acute Ischemic Stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: MILD-MT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No