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

Официальное название

Local Hypothermia and Endovascular Recanalization for Acute Large Artery Occlusive Stroke-A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial

Обзор

A multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial 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.

Подробное описание

This trial aims 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. This study used a stratified randomization method, with participants randomly allocated in a 1:1 ratio by a central network randomization system to either the mechanical thrombectomy (MT) combined with arterial selective cooling infusion (intravenous recombinant tissue plasminogen activator) (hypothermia) group or the MT combined with normal saline infusion (normothermia) group (hereinafter referred to as the hypothermia group or normothermia group). Randomization was stratified by ASPECTS score (≥8 or \<8) and age (≥75 years or \<75 years).

Вмешательства

• Процедура Mechanical thrombectomy
  Mechanical thrombectomy
• Препарат 4°C saline infusion
  Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
• Препарат Normothermic saline infusion
  Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).

Первичные конечные точки

• Proportion of patients with modified Rankin Score 0-2 at 90 days. [Срок оценки: 90 days after procedure]

Вторичные конечные точки (5)

• Proportion of patients with modified Rankin Score 0-1 at 90 days [Срок оценки: 90 days after procedure]
• Successful reperfusion rate [Срок оценки: At the end of the operation]
• Cerebral infarction volume was measured by CT or magnetic resonance DWI 72 hours to 7 days after operation [Срок оценки: 72 hours to 7 days after procedure]
• Incidence of early neurological deterioration [Срок оценки: Within 24 hours after procedure]
• Rate of recurrent occlusion on MRA or CTA (postoperative 24 Hours to 7 Days) [Срок оценки: postoperative 24 Hours to 7 Days]

Критерии участия

Критерии включения

• Age ≥18 and ≤85 years old.
• Symptoms of sudden focal or general neurological impairment.
• There may be a causal relationship between vascular occlusion and nerve function defect.
• Time from symptom onset to randomization ≤24h.
• The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
• According to the judgment of the clinician, the operation path is reasonable, and the operation and operation related instruments can reach the disease smoothly.
• 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.
• Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment).
• The symptoms are aggravated by recurrent cerebral infarction in the same drainage basin and/or the pathogenesis is caused by decreased blood perfusion.

Критерии исключения

• Pre stroke mRS>1 score.
• There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
• NIHSS≤6 points.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Second Provincial General Hospital — Гуанчжоу

Публикации

• Sun W, Zhang X, Hu M, Ouyang D, Liu Y, Zhou L, Huang ZX; CHILL-ART Group. Catheter-Based Focal Hypothermia With Endovascular Reperfusion in Acute Anterior Circulation Large Artery Occlusion Stroke (CHILL-ART): A Randomized Controlled Trial Protocol. Stroke Vasc Interv Neurol. 2025 Dec 11;6(1):e002058. doi: 10.1161/SVIN.125.002058. eCollection 2026 Jan. PMID 41816520

Идентификаторы

NCT: NCT06758609 · CHILL-ART

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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