Hypothermia with endovascular thrombectomy for acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study investigates adding brain hypothermia to standard endovascular thrombectomy in adults with acute ischemic stroke due to large vessel occlusion. Participants must be adults with NIHSS of 6 or higher, specific artery occlusions, and imaging showing viable brain tissue, and they must be eligible for thrombectomy. The goal is to see if cooling can extend the time window for treatment and reduce infarct growth without increasing adverse events like pneumonia or bleeding. The trial compares hypothermia plus thrombectomy to thrombectomy alone, measuring safety and clinical outcomes. Enrollment takes place at Xiangtan Central Hospital in China, with lead sponsor Xinqiao Hospital of Chongqing and collaborators at Xiangtan Central Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥ 18 years or more;
2. acute ischemic stroke within 24 hours from onset to randomization;
3. NIHSS ≥6 points before randomization;
4. Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA/DSA;
5. Baseline ASPECTS score ≥ 3 and ≤10, or cerebral infarction core volume \< 100ml;
6. The patient decides to undergo endovascular therapy;
7. The patient or patient's representative signs a written informed consent form.

Exclusion Criteria:

1. CT or MR evidence of hemorrhage;
2. Pre-randomization rectal temperature ≥ 38℃ or axillary/tympanic temperature ≥ 37.5℃;
3. Currently pregnant or lactating (women patients);
4. Allergy to radiographic contrast agents, or nitinol devices;
5. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
6. Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
7. Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
8. Previous bleeding disorders, severe heart (especially congestive heart failure), liver or kidney disease, or sepsis;
9. Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
10. Intracranial aneurysm, arteriovenous malformation;
11. Any terminal illness with life expectancy less than 6 months;
12. Participating in other clinical trials.

Where it's running

• Xiangtan Central Hospital
  Xiangtan, Hunan, China Recruiting
• Xiangtan Central Hospital
  Xiangtan, Hunan, China Recruiting

Study contacts

• Study coordinator: Guangxiong Yuan, M.S.
• Email: yuanguangxiong74@163.com
• Phone: 18973223018

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.