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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mechanical thrombectomy, 4°C saline infusion, Normothermic saline infusion.
- Who it may be relevant to
- Registry conditions: Acute Cerebrovascular Accident, Acute Ischemic Stroke, Internal Carotid Artery, Middle Cerebral Artery Occlusion. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Local Hypothermia and Endovascular Recanalization for Acute Large Artery Occlusive Stroke-A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial
Overview
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.
Detailed description
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).
Interventions
- Procedure Mechanical thrombectomy
Mechanical thrombectomy - Drug 4°C saline infusion
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT). - Drug Normothermic saline infusion
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
Primary outcome measures
- Proportion of patients with modified Rankin Score 0-2 at 90 days. [Time frame: 90 days after procedure]
Secondary outcome measures (5)
- Proportion of patients with modified Rankin Score 0-1 at 90 days [Time frame: 90 days after procedure]
- Successful reperfusion rate [Time frame: At the end of the operation]
- Cerebral infarction volume was measured by CT or magnetic resonance DWI 72 hours to 7 days after operation [Time frame: 72 hours to 7 days after procedure]
- Incidence of early neurological deterioration [Time frame: Within 24 hours after procedure]
- Rate of recurrent occlusion on MRA or CTA (postoperative 24 Hours to 7 Days) [Time frame: postoperative 24 Hours to 7 Days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong Second Provincial General Hospital — Guangzhou
Publications
- 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
Identifiers
NCT: NCT06758609 · CHILL-ART