Acute ischemic stroke (AIS) is one of the leading causes of disability and mortality worldwide. The treatment of this condition is time-critical, with the key to effective therapy being the early recanalization of the occluded vessel and restoration of blood flow to salvage the ischemic penumbra tissue. Currently, the time window for endovascular treatment in the anterior circulation can be extended up to 24 hours. Exploring endovascular treatments for patients beyond this time window (from 24 hours to 30 days) could mean hope for a greater number of AIS patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.
Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician.
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90
Modified Rankin Scale:1. Total asymptomatic score 0 2, despite symptoms, but no obvious dysfunction, can complete all daily work and life score 1 Mildly disabled, unable to complete all pre-illness activities, but able to take care of daily tasks without assistance score 2 3, moderate disability, need some help, but can walk independently score 3 4, moderate to severe disability, can not walk independently, daily life needs help from others score 4 5, severe disability, bed rest, urinary incontinence, daily life completely dependent on others score 5 6. Death score 6
Time frame: 90days
Proportion of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. Dead.
Time frame: 90days
Sustained vessel recanalization rate at 90 days
Assessment on the 90th day via MRA or CTA
Time frame: 90days
Assessment of activities of daily living at 90 days
Barthel Index
Time frame: 90days
Proportion with "early improvement" between day 2-7 post-randomization/discharge
Defined as a decrease of ≥4 points from baseline in NIHSS or an NIHSS score of 0 or 1
Time frame: 2-7days
Difference in median infarct volume size at 24 (-6/+24) hours post-randomization
Assessment of the infarct volume through imaging (MRI)
Time frame: 24hours
Vessel recanalization at 24 (-6/+24) hours post-randomization
assessed by MRA/CTA
Time frame: 24hours
EQ-5D-5L questionnaire score at 90 days
EQ-5D-5L Scales
Time frame: 90days
Montreal Cognitive Assessment (MoCA) score at 90 days
Montreal Cognitive Assessment (MoCA)
Time frame: 90days
Mini-Mental State Examination (MMSE) score at 90 days
Mini-Mental State Examination (MMSE)
Time frame: 90days
Stroke-related mortality at 90 days
Time frame: 90days
All-cause mortality at 90 days
Time frame: 90days
New stroke or TIA within 90 days
The patient had a transient ischemic attack, symptoms of cerebral infarction, or the presence of cerebral infarction confirmed by imaging
Time frame: 90days
Symptomatic intracranial hemorrhage (sICH)
Defined as a worsening of 4 or more points on the NIHSS within 24 (-6/+24) hours post-randomization and associated with cerebral hemorrhage
Time frame: 24hours
Substantial hematoma type 2 within 24 (-6/+24) hours post-randomization
Substantial hematoma type 2, accounting for more than 30% of the infarct area, with associated space-occupying effect and leading to clinical condition deterioration
Time frame: 24hours
Neurological deterioration
Defined as an increase of ≥4 points in NIHSS score from baseline
Time frame: 2-7days
For the treatment group only: Assessment of cerebral collateral circulation in ischemic stroke
according to the ASITN/SIR collateral grading scale
Time frame: Post procedure 24hours
Procedure-related complications
a) Distal embolization in different regions; b) Iatrogenic arterial dissection; c) Arterial perforation; d) Access site complications of interventional treatment
Time frame: Post procedure 24hours
For the treatment group only: Analysis of post-procedure vascular reperfusion rate (percentage)
eTIMI grade ≥2b
Time frame: Post procedure 24hours
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