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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Endovascular treatment combined with standard medical treatment |
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| Control group | Other | Standard medical treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90days |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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Inclusion Criteria:
General Inclusion Criteria
Imaging Inclusion Criteria
Assessed by Computed Tomography Perfusion (CTP) or Perfusion Weighted Imaging (PWI) with MRI: Infarct core volume is less than 100 mL and the mismatch ratio is ≥1.2 or the mismatch volume is ≥10 mL.
Clinical imaging mismatch is defined by MR-DWI or CTP-rCBF images as:
Exclusion Criteria:
General Exclusion Criteria
Imaging Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hubo, Doctor | Contact | +86 13707114863 | hubo@mail.hust.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
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| Standard medical treatment | Other | Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician. |
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| 90days |
| Sustained vessel recanalization rate at 90 days | Assessment on the 90th day via MRA or CTA | 90days |
| Assessment of activities of daily living at 90 days | Barthel Index | 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 | 2-7days |
| Difference in median infarct volume size at 24 (-6/+24) hours post-randomization | Assessment of the infarct volume through imaging (MRI) | 24hours |
| Vessel recanalization at 24 (-6/+24) hours post-randomization | assessed by MRA/CTA | 24hours |
| EQ-5D-5L questionnaire score at 90 days | EQ-5D-5L Scales | 90days |
| Montreal Cognitive Assessment (MoCA) score at 90 days | Montreal Cognitive Assessment (MoCA) | 90days |
| Mini-Mental State Examination (MMSE) score at 90 days | Mini-Mental State Examination (MMSE) | 90days |
| Stroke-related mortality at 90 days | 90days |
| All-cause mortality at 90 days | 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 | 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 | 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 | 24hours |
| Neurological deterioration | Defined as an increase of ≥4 points in NIHSS score from baseline | 2-7days |
| For the treatment group only: Assessment of cerebral collateral circulation in ischemic stroke | according to the ASITN/SIR collateral grading scale | 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 | Post procedure 24hours |
| For the treatment group only: Analysis of post-procedure vascular reperfusion rate (percentage) | eTIMI grade ≥2b | Post procedure 24hours |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |