Endovascular Treatment for Stroke Post 1 Day （24 Hours）

Official title

Endovascular Treatment Post 1 Day （24 Hours）: a Randomized Controlled Clinical Trial on Efficacy and Safety for Stroke

Overview

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

• Procedure Endovascular 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
• Other Standard medical treatment
  Patients randomized to the control group will receive best conventional MT for acute ischemic stroke as determined by the attending stroke physician.

Primary outcome measures

• The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 [Time frame: 90days]

Secondary outcome measures (12)

• Proportion of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence [Time frame: 90days]
• Sustained vessel recanalization rate at 90 days [Time frame: 90days]
• Assessment of activities of daily living at 90 days [Time frame: 90days]
• Proportion with "early improvement" between day 2-7 post-randomization/discharge [Time frame: 2-7days]
• Difference in median infarct volume size at 24 (-6/+24) hours post-randomization [Time frame: 24hours]
• Vessel recanalization at 24 (-6/+24) hours post-randomization [Time frame: 24hours]
• EQ-5D-5L questionnaire score at 90 days [Time frame: 90days]
• Montreal Cognitive Assessment (MoCA) score at 90 days [Time frame: 90days]
• Mini-Mental State Examination (MMSE) score at 90 days [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 [Time frame: 90days]

Eligibility criteria

Inclusion criteria

• General Inclusion Criteria

• Age≥18 and ≤80
• Baseline NIHSS ≥ 6 and maintained ≥ 6 before randomization
• Stroke onset or more than 24 hours from the last known well state and within 30 days.
• Pre-stroke mRS score of 0 or 1 points
• The subject or their legally authorized representative has signed the informed consent form for the study
• Imaging Inclusion Criteria

• 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)
• Meets one of the following imaging evaluation criteria:

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• 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:

• Infarct volume is less than 30 mL and NIHSS score is ≥10;
• Infarct volume is between 30 mL and 100 mL and NIHSS score is ≥20

Exclusion criteria

• General Exclusion Criteria

• 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)
• Major comorbidities that may interfere with the assessment of results and follow-up (e.g., severe heart failure, renal failure, etc.)
• Rapid improvement in neurologic status to NIHSS<6 or evidence of vascular reconstruction before randomization
• Uncontrolled seizures at the time of stroke onset that, if preventing the acquisition of an accurate baseline NIHSS
• Baseline platelet count<50,000/uL
• Severe persistent hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure>120 mmHg)
• Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an International Normalized Ratio (INR) >3
• Suspected septic emboli, suspected bacterial endocarditis
• Known allergy to iodine, heparin, anesthetics, or other clear contraindications to the endovascular treatment procedure
• Pregnant women
• Other serious, progressive, or terminal illnesses (as judged by the investigator) or life expectancy of less than 6 months
• Attempt to use a neurothrombectomy device to remove the blood clot before randomization
• Currently participating in other studies of investigational drugs or devices
• 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Te — Wuhan

Identifiers

NCT: NCT06580730 · ETP-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗