Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography

Launched by TIANJIN HUANHU HOSPITAL · Oct 22, 2024

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ClinConnect Summary

This clinical trial is looking at whether a specialized treatment called endovascular treatment (EVT) can help patients who have had a severe type of stroke known as large vessel occlusion (LVO) and who seek care more than 24 hours after their symptoms began. The main goal is to see if EVT can improve patients' ability to live independently 90 days after treatment compared to the best medical care available. Researchers will also assess how safe EVT is for these patients compared to standard medical management.

To participate in this trial, individuals must be at least 18 years old, show certain signs of stroke through imaging tests, and have a moderate level of stroke symptoms. They should not have significant disabilities before the stroke and must be willing to attend follow-up appointments. Participants will either receive EVT or the best medical management based on their eligibility and will be monitored for 90 days to evaluate their recovery and safety. If you or someone you know meets these criteria and is interested, it could be a valuable opportunity to contribute to important research in stroke treatment.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Confirmation of ICA or MCA-M1 occlusion, as detected by MRA or CTA, with carotid occlusions potentially occurring in either the cervical or intracranial regions, and the possibility of accompanying tandem MCA lesions.
• • 2. Demonstration of moderate to good collateral flow, as evidenced by CTA imaging.
• • 3. The patient must be aged 18 years or older.
• • 4. The baseline NIHSSS score is equal to or greater than 2, and this score remains equal to or greater than 2 immediately prior to randomization.
• • 5. Endovascular treatment can be initiated (via femoral puncture) within a window of 24 to 72 hours from the onset of the stroke. The onset of the stroke is defined as the time the patient was last known to be at their neurologic baseline (patients with wake-up strokes are eligible if they meet the aforementioned time constraints).
• • 6. There must be no significant pre-stroke disability, as indicated by a pre-baseline modified Rankin Scale score of 0-2.
• • 7. The patient must be willing and able to return for the protocol-required follow-up visits.
• • 8. The patient or their legally authorized representative must have signed the Informed Consent form.
• Exclusion Criteria:
• • 1. The subject has a serious, advanced, or terminal illness (as determined by the investigator) or a life expectancy of less than six months.
• • 2. The subject has a pre-existing medical, neurological, or psychiatric disease that would interfere with neurological or functional evaluations, or is already participating in another drug or device study.
• • 3. The subject is pregnant.
• • 4. The subject has contraindications for both MRI and CT contrast that prevent an MRI or CT contrast perfusion study. The hospital's local standard criteria should be applied to determine if contraindications exist.
• • 5. The subject has a known allergy to iodine and has previously been refractory to pretreatment medications.
• • 6. The subject has been treated with tPA more than 4.5 hours after the last known well time.
• • 7. The subject has a known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or has recently undergone oral anticoagulant therapy with an INR greater than 3.
• • 8. The subject has symptoms consistent with stroke in multiple locations.
• • 9. The subject has seizures at stroke onset, which makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
• • 10. The subject has a baseline blood glucose level of less than 50mg/dL (2.78 mmol) or greater than 400mg/dL (22.20 mmol).
• • 11. The subject has a baseline platelet count of less than 50,000/uL.
• • 12. The subject has severe, sustained hypertension (Systolic Blood Pressure \>185 mmHg or Diastolic Blood Pressure \>110 mmHg) that is not treatable with medications.
• • 13. The subject is currently participating in another investigational drug or device study or registry.
• • 14. The subject is presumed to have a septic embolus, suspicion of bacterial endocarditis, or cerebral vasculitis.
• • 15. The subject has had clot retrieval attempted using a neurothrombectomy device within 24 hours of symptom onset.