To Assess the Effectiveness and Safety of Catheter-based Focal Intracranial Hypothermia Combined with Endovascular Reperfusion Therapy for Patients with Acute Anterior Circulation Large Artery Occlusion

Launched by GUANGDONG SECOND PROVINCIAL GENERAL HOSPITAL · Dec 27, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients who have suffered from a severe type of stroke, specifically when a major blood vessel in the brain becomes blocked. The study is looking at the combination of two methods: cooling the brain using a catheter and a procedure to restore blood flow. The goal is to see if this combined treatment can improve outcomes for patients in the early stages of a stroke.

To participate in this trial, you need to be between 18 and 85 years old and have experienced sudden symptoms related to a stroke, like weakness or trouble speaking, within 24 hours of starting the study. Eligible participants will have a specific level of stroke severity, as measured by a standard scale. If you or a loved one are considering this trial, you'll be asked to sign a consent form to confirm your understanding and willingness to participate. Throughout the study, participants will receive careful monitoring and follow-up to ensure their safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 and ≤85 years old.
• • 2. Symptoms of sudden focal or general neurological impairment.
• • 3. There may be a causal relationship between vascular occlusion and nerve function defect.
• • 4. Time from symptom onset to randomization ≤24h.
• • 5. The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
• • 6. According to the judgment of the clinician, the operation path is reasonable, and the operation and operation related instruments can reach the disease smoothly.
• • 7. Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and are capable of receiving clinical follow-up.
• • 8. Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment).
• • 9. The symptoms are aggravated by recurrent cerebral infarction in the same drainage basin and/or the pathogenesis is caused by decreased blood perfusion.
• Exclusion Criteria:
• • 1. Pre stroke mRS\>1 score.
• • 2. There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
• • 3. NIHSS≤6 points.
• • 4. Cerebral hemorrhage/subarachnoid hemorrhage was confirmed by CT or MRI. 5.The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (Presence of at least one of the following laboratory tests: hemoglobin \< 10g /dl, platelet count \< 100,000 /μl, uncorrected INR\>1.5, PT\> 1 minute above the upper limit of normal, or heparin-related thrombocytopenia).
• • 6.Patients with heart function of grade 1 or above, or with a clear history of acute or chronic heart dysfunction, are at greater risk of acute heart failure or fluid perfusion intolerance as determined by clinicians.
• • 7. Severe heart, liver, kidney disease. 8.With malignant diseases such as malignant tumors, the expected survival time is less than 3 months.
• • 9.Participating in other clinical trials, in the investigational phase or in the follow-up phase.