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NCT06758609Completed

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

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

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
262 (actual)
First submitted
20 Dec 2024
Start date
23 Jan 2025
Primary completion date
11 Sept 2025
Lead sponsor
Guangdong Second Provincial General Hospital
Diseases
Stroke
NCT number
NCT06758609

What you commit to

  • Study type: Interventional
  • Participants enrolled: 262
  • From 23 Jan 2025 to the primary completion date, 11 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Pre stroke mRS\>1 score.

Lab values

  • 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.

Other

  • There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
  • NIHSS≤6 points.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Guangdong Second Provincial General Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.