Endovascular Treatment for Stroke Post 1 Day （24 Hours）

Not Applicable

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Procedure: Endovascular treatment; Other: Standard medical treatment

• Registration Number: NCT06580730
• Lead Sponsor: Wuhan Union Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-24
• Study First Submitted QC: 2024-08-29
• Study First Posted: 2024-08-30
• Last Update Submitted: 2024-08-31
• Study Start: 2024-09-01
• Last Update Posted: 2024-09-05
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 224

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:
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  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 Exclusion Criteria

  1. In the judgment of the clinician responsible for treatment, it is considered unlikely to benefit from the trial (e.g., advanced dementia, severe pre-stroke disability (mRS ≥2), high likelihood of early death)
  2. Major comorbidities that may interfere with the assessment of results and follow-up (e.g., severe heart failure, renal failure, etc.)
  3. Rapid improvement in neurologic status to NIHSS<6 or evidence of vascular reconstruction before randomization
  4. Uncontrolled seizures at the time of stroke onset that, if preventing the acquisition of an accurate baseline NIHSS
  5. Baseline platelet count<50,000/uL
  6. Severe persistent hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure>120 mmHg)
  7. Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an International Normalized Ratio (INR) >3
  8. Suspected septic emboli, suspected bacterial endocarditis
  9. Known allergy to iodine, heparin, anesthetics, or other clear contraindications to the endovascular treatment procedure
  10. Pregnant women
  11. Other serious, progressive, or terminal illnesses (as judged by the investigator) or life expectancy of less than 6 months
  12. Attempt to use a neurothrombectomy device to remove the blood clot before randomization
  13. Currently participating in other studies of investigational drugs or devices
  14. Any other conditions that, in the opinion of the investigator, would impede endovascular surgery or pose a significant risk to the subject during endovascular surgery

• Imaging Exclusion Criteria

  1. Intracranial hemorrhage, including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and epidural/subdural hemorrhage;
  2. Evidence of intracranial tumors as shown by CT or MRI (except for small meningiomas);
  3. CTA/MRA showing excessive tortuosity of the cervical vessels, which may hinder endovascular treatment;
  4. Suspected aortic dissection based on medical history and CTA/MRA;
  5. Presence of an intracranial stent in the same vascular area, which would impede the smooth progress of surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Endovascular treatment	Endovascular treatment combined with standard medical treatment
Control group	Standard medical treatment	Standard medical treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
For the treatment group only: Assessment of cerebral collateral circulation in ischemic stroke	Post procedure 24hours	according to the ASITN/SIR collateral grading scale
Sustained vessel recanalization rate at 90 days	90days	Assessment on the 90th day via MRA or CTA
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)
All-cause mortality at 90 days	90days
For the treatment group only: Analysis of post-procedure vascular reperfusion rate (percentage)	Post procedure 24hours	eTIMI grade ≥2b
Assessment of activities of daily living at 90 days	90days	Barthel Index
Vessel recanalization at 24 (-6/+24) hours post-randomization	24hours	assessed by MRA/CTA
Montreal Cognitive Assessment (MoCA) score at 90 days	90days	Montreal Cognitive Assessment (MoCA)
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
EQ-5D-5L questionnaire score at 90 days	90days	EQ-5D-5L Scales
Stroke-related mortality at 90 days	90days
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
Mini-Mental State Examination (MMSE) score at 90 days	90days	Mini-Mental State Examination (MMSE)
Neurological deterioration	2-7days	Defined as an increase of ≥4 points in NIHSS score from baseline
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

Trial Locations

Locations (1)

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China