Direct Endovascular Treatment Versus Bridging Treatment In Basilar Artery Occlusive Stroke

Launched by SICHUAN ACADEMY OF MEDICAL SCIENCES · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the best way to treat a specific kind of stroke called acute ischemic stroke due to basilar artery occlusion (BAO). Researchers want to find out whether patients do better with a direct endovascular treatment alone or if they should first receive a medication called intravenous thrombolysis (IVT) before the endovascular treatment. This study will involve multiple hospitals and aims to compare the recovery outcomes for both treatment methods over a three-month period.

To participate in this trial, individuals must be at least 18 years old and have experienced a stroke caused by BAO, confirmed through imaging tests. They should also be eligible for both IVT and endovascular treatment within 4.5 hours of their symptoms starting and have a certain level of stroke severity. Participants will receive close monitoring and assessments of their recovery, including their ability to carry out daily activities and overall health over the following months. Importantly, the study seeks to understand not just how well patients recover, but also to ensure their safety throughout the treatment process.

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ALL

Eligibility criteria

• Inclusion criteria:
• • 1. A clinical diagnosis of AIS.
• • 2. Caused by BAO confirmed by CTA, MRA, or DSA. (BAO is defined as the absence of visualization of the basilar artery on CTA, MRA or DSA. Bilateral vertebral artery occlusions or occlusion of a unilateral vertebral artery that is the sole supplier of the basilar artery, even in the presence of patent basilar artery, will be considered de facto BAO.)
• • 3. CT or MRI ruling out intracranial hemorrhage,
• • 4. Eligible for IVT and EVT (within 4.5 hours of symptom onset). (Symptoms onset is defined as point in time the patient was last seen well \[at baseline\] if patients are unable to provide a reliable history or the point in time when symptoms have started if patients can provide a reliable history. Symptoms onset includes diplopia, midline ataxia, visual loss, sensory or motor deficits, and conscious disturbance. Isolated vertigo \[not accompanied by dysarthria, motor weakness, sensory symptoms, double vision, depressed level of consciousness\] is not considered onset of symptoms.)
• • 5. NIHSS score ≥ 6.
• • 6. Age ≥ 18 years.
• • 7. Signed informed consent by the patient or legal representative.
• Exclusion criteria:
• • 1. mRS score \> 2 before this stroke.
• 2. Any contraindication to IVT as per the 2019 AHA/ASA guidelines for early management of AIS:
• • 1) Blood pressure \> 185/110 mmHg and cannot be controlled by standard medication, 2) Blood glucose \< 50mg/dL (2.8 mmol/L) or \> 400mg/dL (22.2 mmol/L), 3) Had a cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuroimaging, 4) Severe head trauma in the previous 3 months, 5) Major surgery or severe trauma in the previous 2 weeks, 6) Gastrointestinal or urinary bleeding in the previous 3 weeks, 7) previous intracranial hemorrhage, 8) Using anticoagulants and International normalized ratio (INR) \> 1.7, 9) Known platelet count \< 100 × 109/L, 10) treatment with direct thrombin or factor X inhibitors, 11) Heparin treatment in the previous 48 hours with the activated partial thromboplastin time (APTT) exceeding the upper limit of normal.
• • (3) Pregnancy, breastfeeding, or intention to conceive during the study period. (4) Other conditions deemed unsuitable by the investigator.