Trial of Rescue Endovascular Treatment for Progressive Acute Mild Ischemic Stroke With Basilar Artery Occlusion With Extended Time Window

Launched by FIRST AFFILIATED HOSPITAL OF WANNAN MEDICAL COLLEGE · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients who are experiencing a specific type of stroke called acute mild ischemic stroke due to blockage in the basilar artery. The study aims to find out if combining the standard medical treatment with a procedure called endovascular therapy (which helps open up the blocked artery) can lead to better recovery outcomes compared to just using standard treatment alone. The trial is open to adults aged 18 and older who have symptoms of a basilar artery blockage and have experienced a worsening of their stroke symptoms within a week.

Participants in the study will undergo assessments to see if they qualify based on their symptoms and medical history. If eligible, they will be randomly assigned to either receive the combined treatment or just the standard care. Throughout the trial, participants will be monitored closely for their progress and any side effects. It's important for potential participants and their families to understand that the study is focused on exploring new ways to improve recovery from this serious condition, and their involvement could contribute valuable information to medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years.
• • 2. Symptoms and signs consistent with basilar artery ischemia.
• • 3. Basilar artery or vertebral artery occlusion confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA); if vertebral artery occlusion is present, it should completely block blood flow along the basilar artery.
• • 4. First-time onset meeting the criteria for mild ischemic stroke diagnosis: NIHSS score \<6.
• • 5. Symptom progression within 7 days of the first onset.
• • 6. Symptom progression: NIHSS score increase ≥4 points or consciousness level increase ≥2 points from the initial NIHSS score.
• • 7. Time from symptom onset to randomization \>24 hours.
• • 8. Symptom progression to randomization time ≤24 hours.
• • 9. NIHSS score ≥10 before randomization.
• • 10. pc-ASPECTS before randomization ≥ 6
• • 11. The patient or their family members are willing to comply with the protocol requirements and data collection procedures, understand, and sign the informed consent form.
• Exclusion Criteria:
• • 1. Symptom progression due to intracranial hemorrhage, brain edema, or other clear causes (including but not limited to infarct hemorrhagic transformation, new infarction in non-occluded vascular regions, severe infection, high fever, heart or kidney dysfunction, hypovolemia, or severe electrolyte disturbances).
• • 2. mRS \>2.
• • 3. Factors in the target vessel that are expected to prevent completion of endovascular treatment.
• • 4. Multiple vessel occlusions.
• • 5. Prior imaging confirmed or investigator-assessed chronic basilar artery occlusion.
• • 6. Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
• • 7. Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
• • 8. Gastrointestinal or urinary tract bleeding, acute myocardial infarction, cranial trauma, or major surgery within the past month.
• • 9. Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
• • 10. Platelet count \<40×10\^9/L, or INR \>2 during anticoagulation therapy (irreversible).
• • 11. Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
• • 12. Known allergy to iodine contrast agents or other treatment-related drugs.
• • 13. Medically uncontrolled refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) (Note: Participants can be included if their blood pressure is controllable with medication and maintained at an acceptable level).
• • 14. Uncontrollable blood glucose \<2.8 mmol/L or \>22.2 mmol/L.
• • 15. Pregnancy or breastfeeding.
• • 16. Life expectancy \<6 months.
• • 17. Participation in other clinical studies that may affect outcome assessment.
• • 18. Investigator's judgment that the patient is unsuitable for participation in this study or may face significant risks (e.g., due to mental illness, cognitive, or emotional disorders preventing understanding and/or compliance with study procedures and/or follow-up).