Acute Ischemic Stroke
Conditions
Brief summary
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.
Interventions
PROCEDUREEndovascular treatment
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.
OTHERStandard medical treatment
Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria 1. Age≥18 and ≤80 2. Baseline NIHSS ≥ 6 and maintained ≥ 6 before randomization 3. Stroke onset or more than 24 hours from the last known well state and within 30 days. 4. Pre-stroke mRS score of 0 or 1 points 5. The subject or their legally authorized representative has signed the informed consent form for the study * Imaging Inclusion Criteria 1. Magnetic Resonance Angiography (MRA), Computed Tomography Angiography (CTA), or Digital Subtraction Angiography (DSA) confirms the occlusion of major intracranial vessels (occlusion of the internal carotid artery and/or the middle cerebral artery M1/M2 segment) 2. Meets one of the following imaging evaluation criteria: <!-- --> 1. 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. 2. Clinical imaging mismatch is defined by MR-DWI or CTP-rCBF images as: 1. Infarct volume is less than 30 mL and NIHSS score is ≥10; 2. Infarct volume is between 30 mL and 100 mL and NIHSS score is ≥20
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 | 90days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained vessel recanalization rate at 90 days | 90days | Assessment on the 90th day via MRA or CTA |
| Assessment of activities of daily living at 90 days | 90days | Barthel Index |
| Proportion with early improvement between day 2-7 post-randomization/discharge | 2-7days | Defined as a decrease of ≥4 points from baseline in NIHSS or an NIHSS score of 0 or 1 |
| Difference in median infarct volume size at 24 (-6/+24) hours post-randomization | 24hours | Assessment of the infarct volume through imaging (MRI) |
| Vessel recanalization at 24 (-6/+24) hours post-randomization | 24hours | assessed by MRA/CTA |
| EQ-5D-5L questionnaire score at 90 days | 90days | EQ-5D-5L Scales |
| Montreal Cognitive Assessment (MoCA) score at 90 days | 90days | Montreal Cognitive Assessment (MoCA) |
| Mini-Mental State Examination (MMSE) score at 90 days | 90days | Mini-Mental State Examination (MMSE) |
| Proportion of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence | 90days | 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. |
| All-cause mortality at 90 days | 90days | — |
| New stroke or TIA within 90 days | 90days | The patient had a transient ischemic attack, symptoms of cerebral infarction, or the presence of cerebral infarction confirmed by imaging |
| Symptomatic intracranial hemorrhage (sICH) | 24hours | Defined as a worsening of 4 or more points on the NIHSS within 24 (-6/+24) hours post-randomization and associated with cerebral hemorrhage |
| Substantial hematoma type 2 within 24 (-6/+24) hours post-randomization | 24hours | Substantial hematoma type 2, accounting for more than 30% of the infarct area, with associated space-occupying effect and leading to clinical condition deterioration |
| Neurological deterioration | 2-7days | Defined as an increase of ≥4 points in NIHSS score from baseline |
| For the treatment group only: Assessment of cerebral collateral circulation in ischemic stroke | Post procedure 24hours | according to the ASITN/SIR collateral grading scale |
| Procedure-related complications | Post procedure 24hours | a) Distal embolization in different regions; b) Iatrogenic arterial dissection; c) Arterial perforation; d) Access site complications of interventional treatment |
| For the treatment group only: Analysis of post-procedure vascular reperfusion rate (percentage) | Post procedure 24hours | eTIMI grade ≥2b |
| Stroke-related mortality at 90 days | 90days | — |
Countries
China
Contacts
Primary ContactHubo, Doctor
Outcome results
None listed