Endovascular Treatment for Stroke Post 1 Day （24 Hours）
NCT Number: NCT06580730
Acronym: ETP-1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Ischemic Stroke
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 224
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-01

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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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., 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