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
NCT ID: NCT06758609
Last Updated: 2025-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
262 participants
INTERVENTIONAL
2024-12-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
Mechanical thrombectomy
Mechanical thrombectomy
4°C saline infusion
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
Mechanical thrombectomy combined with normothermic saline infusion (normothermia) group
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
Mechanical thrombectomy
Mechanical thrombectomy
Normothermic saline infusion
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
Interventions
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Mechanical thrombectomy
Mechanical thrombectomy
4°C saline infusion
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
Normothermic saline infusion
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Guangdong Second Provincial General Hospital
OTHER
Responsible Party
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Zhixin Huang
Principal Investigator
Locations
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Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHILL-ART
Identifier Type: -
Identifier Source: org_study_id
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