Assessing Local Hypothermia and Endovascular Recanalization for Acute Stroke With a Large Core Infarction

NCT07232082 | Not Yet Recruiting DMC

• 1 other identifier: 20250913
• Study Type: interventional
• Target: 322
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 acute patients with a Large Core Infarction.

Conditions

Stroke; Large Ischemic Core

Keywords

endovascular therapy; Hypothermia

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with modified Rankin Score 0-2 at 90 days.

  The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

  90±7 days after randomization

Secondary Outcomes (7)

• Neurofunctional deficit defined as modified Rankin Scale (mRS)

  90±7 days after randomization

• Proportion of patients with modified Rankin Score 0-1 at 90 days

  90±7 days after randomization

• Proportion of patients with modified Rankin Score 0-3 at 90 days.

  90±7 days after randomization

• Rate of symptomatic intracranial hemorrhage within 48 hours (Heidelberg Bleeding Classification)

  within 48±12 hours after randomization

• All-Cause Mortality within 90 (±7) Days Post-Randomization

  90±7 days after randomization

Study Arms (2)

Normothermial group

ACTIVE COMPARATOR

In the contral group, after crossing the occluded vessel segment with a microcatheter and confirming its location in the true lumen, roomtemperature saline will be extracted from the refrigerator. 50ml will be drawn within 2 minutes and then continuously infused at a rate of 10ml/min using an infusion pump. After infusion, standard thrombectomy procedures will be performed. After completion of the thrombectomy procedure (regardless of achieving 2b/3-grade reperfusion), another roomtemperature 300ml of saline will be extracted within 2 minutes and infused at a rate of 30ml/min for 10 minutes through the intermediate catheter or guiding catheter placed in the internal carotid artery.

Other: Control (Normal saline)

Hypothermia group

EXPERIMENTAL

In the treatment group, after crossing the occluded vessel segment with a microcatheter and confirming its location in the true lumen, 4℃-saline will be extracted from the refrigerator. 50ml will be drawn within 2 minutes and then continuously infused at a rate of 10ml/min using an infusion pump. After infusion, standard thrombectomy procedures will be performed. After completion of the thrombectomy procedure (regardless of achieving 2b/3-grade reperfusion), another 300ml of saline will be extracted within 2 minutes and infused at a rate of 30ml/min for 10 minutes through the intermediate catheter or guiding catheter placed in the internal carotid artery. Post-infusion, contrast-enhanced cerebral angiography using room temperature contrast agent is generally not recommended to dilute the local temperature.

Other: intra-arterial local therapeutic hypothermia

Interventions

intra-arterial local therapeutic hypothermia OTHER

In the treatment group, after crossing the occluded vessel segment with a microcatheter and confirming its location in the true lumen, 4℃-saline will be extracted from the refrigerator. 50ml will be drawn within 2 minutes and then continuously infused at a rate of 10ml/min using an infusion pump. After infusion, standard thrombectomy procedures will be performed. After completion of the thrombectomy procedure (regardless of achieving 2b/3-grade reperfusion), another 300ml of saline will be extracted within 2 minutes and infused at a rate of 30ml/min for 10 minutes through the intermediate catheter or guiding catheter placed in the internal carotid artery. Post-infusion, contrast-enhanced cerebral angiography using room temperature contrast agent is generally not recommended to dilute the local temperature.

Hypothermia group

Control (Normal saline) OTHER

In the contral group, after crossing the occluded vessel segment with a microcatheter and confirming its location in the true lumen, roomtemperature saline will be extracted from the refrigerator. 50ml will be drawn within 2 minutes and then continuously infused at a rate of 10ml/min using an infusion pump. After infusion, standard thrombectomy procedures will be performed. After completion of the thrombectomy procedure (regardless of achieving 2b/3-grade reperfusion), another roomtemperature 300ml of saline will be extracted within 2 minutes and infused at a rate of 30ml/min for 10 minutes through the intermediate catheter or guiding catheter placed in the internal carotid artery.

Normothermial group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old.
• The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
• Time from symptom onset to randomization ≤24h.
• 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).
• NCCT ASPECTS value of 3 to 5 based on findings from non-contrast CT within 24 hours after stroke onset (defined as the time the patient was last known to be well), with no limitation with respect to infarct-core volume;
• NCCT ASPECTS value of 0 to 2 based on findings from non-contrast CT within 24 hours after stroke onset and an infarct-core volume between 70 ml and 100 ml;
• NCCT ASPECTS value greater than 5 based on findings from non-contrast CT after stroke onset and an infarct-core volume of 70 to 100 ml.

You may not qualify if:

• Pre stroke mRS\>1 score.
• Multivessel Occlusion
• Concomitant untreated intracranial aneurysms, intracranial tumors (with the exception of small meningiomas), or intracranial vascular malformations.
• History of intracranial hemorrhage within 6 months, including parenchymal hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
• History of gastrointestinal hemorrhage, genitourinary bleeding, acute myocardial infarction (AMI), cranial trauma, or having undergone major surgical procedures within the past month.
• The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (platelet count \< 40,000 /μl, uncorrected INR\>2.0).
• 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.
• Severe heart, liver, kidney disease.
• Known allergy to contrast media or related medications.
• Refractory hypertension uncontrolled by medication (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
• glucose \<2.8 mmol/L or \>22.2 mmol/L；
• Pregnancy or lactation；
• the expected survival time is less than 12 months.
• Participating in other clinical trials, in the investigational phase or in the follow-up phase.
• Other conditions deemed by investigators to pose significant risks or render participation unsuitable (e.g. inability to comply due to psychiatric/cognitive/emotional disorders).

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

MeSH Terms

Conditions

Stroke; Hypothermia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Zhiming Zhou, PhD

CONTACT

(++)86-(+)-553-5739543; neuro_depar@hotmail.com

Xianjun Huang, PhD

CONTACT

(++)86-(+)-553-5739543; doctorhuangxj@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 7, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share