StrokeRESCUE-LCINCT07232082
Assessing Local Hypothermia and Endovascular Recanalization for Acute Stroke With a Large Core Infarction
A study testing intra-arterial local therapeutic hypothermia in people with Stroke and Large Ischemic Core, run by First Affiliated Hospital of Wannan Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Large Ischemic Core
- What is being tested?
- intra-arterial local therapeutic hypothermia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 7 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria：
- 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.
- Specific Neuroimaging Inclusion Criteria
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- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing Local Hypothermia and Endovascular Recanalization for Acute Stroke With a Large Core Infarction-A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial
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.
Read the 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 patients with a Large Core Infarction. Participants were centrally randomized in a 1:1 ratio to either endovascular thrombectomy (EVT) combined with intra-arterial cold saline infusion (IA-CSI) (hypothermia group) or EVT combined with normothermic saline infusion (normothermia group).
- Conditions
- Stroke, Large Ischemic Core
- Being tested
- intra-arterial local therapeutic hypothermia, Control (Normal saline)
- Keywords
- endovascular therapy, Hypothermia
- Medical subject headings
- Stroke, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-arterial local therapeutic hypothermiaOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: intra-arterial local therapeutic hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90±7 days after randomization
Secondary outcomes (7)
Neurofunctional deficit defined as modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Measured: 90±7 days after randomization
Proportion of patients with modified Rankin Score 0-1 at 90 days
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Measured: 90±7 days after randomization
Proportion of patients with modified Rankin Score 0-3 at 90 days.
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Measured: 90±7 days after randomization
Rate of symptomatic intracranial hemorrhage within 48 hours (Heidelberg Bleeding Classification)
Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 48 hours of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma. The sICH was defined as ICH associated with a worsening of 4 or more points on the NIHSS or resulting in death, and cerebral herniation, which were not present at baseline.
Measured: within 48±12 hours after randomization
All-Cause Mortality within 90 (±7) Days Post-Randomization
The modified Rankin Scale is a graded ordinal scale that ranges between 0 and 6, where a score of 6 is assigned to indicate mortality.
Measured: 90±7 days after randomization
Any type of intracranial hemorrhage according to Heidelberg Classification.
Any type of intracranial hemorrhage according to Heidelberg Classification.
Measured: within 48±12 hours after randomization
Incidence rate of malignant cerebral edema within 72 (±48) hours post-randomization
Patients with MCE were defined as those with: (1) infarct lesions with obvious space-occupying mass effect with more than 50% of the MCA territory and signs of local brain swelling such as sulcal effacement and compression of the lateral ventricle and (2) midline shift of ≥5 mm at the septum pellucidum or pineal gland with obliteration of the basal cisterns
Measured: 72 (±48) hours post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 May 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion7 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232082
- Sponsor's protocol ID
- 20250913
- Acronym
- RESCUE-LCI
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Local Hypothermia and Endovascular Recanalization for Acute Stroke With a Large Core Infarction-A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07232082
- Acronym / sponsor ID
- RESCUE-LCI / 20250913
- Conditions
- Stroke, Large Ischemic Core
- Keywords
- endovascular therapy, Hypothermia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 7 Apr 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patients with a Large Core Infarction. Participants were centrally randomized in a 1:1 ratio to either endovascular thrombectomy (EVT) combined with intra-arterial cold saline infusion (IA-CSI) (hypothermia group) or EVT combined with normothermic saline infusion (normothermia group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normothermial group | Active comparator | Other: Control (Normal saline)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. |
| Hypothermia group | Experimental | Other: intra-arterial local therapeutic hypothermiaIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- General Inclusion Criteria：
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-arterial local therapeutic hypothermiaIn 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 | Hypothermia group |
| Control (Normal saline)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 | Normothermial group |
Primary outcome
Proportion of patients with modified Rankin Score 0-2 at 90 days.
Time frame: 90±7 days after randomization
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
7 secondary outcomes
Neurofunctional deficit defined as modified Rankin Scale (mRS)
Time frame: 90±7 days after randomization
Proportion of patients with modified Rankin Score 0-1 at 90 days
Time frame: 90±7 days after randomization
Proportion of patients with modified Rankin Score 0-3 at 90 days.
Time frame: 90±7 days after randomization
Rate of symptomatic intracranial hemorrhage within 48 hours (Heidelberg Bleeding Classification)
Time frame: within 48±12 hours after randomization
All-Cause Mortality within 90 (±7) Days Post-Randomization
Time frame: 90±7 days after randomization
Any type of intracranial hemorrhage according to Heidelberg Classification.
Time frame: within 48±12 hours after randomization
Incidence rate of malignant cerebral edema within 72 (±48) hours post-randomization
Time frame: 72 (±48) hours post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing intra-arterial local therapeutic hypothermia in people with Stroke and Large Ischemic Core, run by First Affiliated Hospital of Wannan Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiming Zhou, PhD ((++)86-(+)-553-5739543, neuro_depar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with modified Rankin Score 0-2 at 90 days. (time frame: 90±7 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.