Acute Cerebrovascular AccidentCHILL-ARTNCT06758609
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
A study testing Mechanical thrombectomy, 4°C saline infusion and Normothermic saline infusion in people with Acute Cerebrovascular Accident and Acute Ischemic Stroke, run by Guangdong Second Provincial General Hospital at 1 site in China.
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 patients with acute anterior circulation large artery occlusion. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Cerebrovascular Accident, Acute Ischemic Stroke, Internal Carotid Artery
- What is being tested?
- Mechanical thrombectomy, 4°C saline infusion and Normothermic saline infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2025to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Pre stroke mRS>1 score.
- There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
- NIHSS≤6 points.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
About this study
Official title: Local Hypothermia and Endovascular Recanalization for Acute Large Artery Occlusive Stroke-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 patients with acute anterior circulation large artery occlusion.
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 anterior circulation large artery occlusion. This study used a stratified randomization method, with participants randomly allocated in a 1:1 ratio by a central network randomization system to either the mechanical thrombectomy (MT) combined with arterial selective cooling infusion (intravenous recombinant tissue plasminogen activator) (hypothermia) group or the MT combined with normal saline infusion (normothermia) group (hereinafter referred to as the hypothermia group or normothermia group). Randomization was stratified by ASPECTS score (≥8 or <8) and age (≥75 years or <75 years).
- Conditions
- Acute Cerebrovascular Accident, Acute Ischemic Stroke, Internal Carotid Artery, Middle Cerebral Artery Occlusion
- Being tested
- Mechanical thrombectomy, 4°C saline infusion, Normothermic saline infusion
- Medical subject headings
- Stroke, Ischemic Stroke, Infarction, Middle Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyProcedure or surgery
Mechanical thrombectomy
4°C saline infusionDrug
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
Normothermic saline infusionDrug
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
| Study group | Role | What they receive |
|---|---|---|
| Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group | Experimental | Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT). Receives: Procedure: Mechanical thrombectomy; Drug: 4°C saline infusion |
| Mechanical thrombectomy combined with normothermic saline infusion (normothermia) group | Active comparator | Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT). Receives: Procedure: Mechanical thrombectomy; Drug: Normothermic saline infusion |
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 days after procedure
Secondary outcomes (5)
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 days after procedure
Successful reperfusion rate
Successful reperfusion was indicated by modified Thrombolysis in Cerebral Infarction (mTICI) grade 2b or 3.
Measured: At the end of the operation
Cerebral infarction volume was measured by CT or magnetic resonance DWI 72 hours to 7 days after operation
Cerebral infarction volume was measured by CT or DWI 72 hours to 7 days after operation.
Measured: 72 hours to 7 days after procedure
Incidence of early neurological deterioration
Early neurological deterioration was defined as an increase of 4 or more points on the NIHSS within 24 hours that was not attributable to intracerebral hemorrhage.
Measured: Within 24 hours after procedure
Rate of recurrent occlusion on MRA or CTA (postoperative 24 Hours to 7 Days)
Recurrent occlusion was measured by MRA or CTA 24 hours to 7 days after operation.
Measured: postoperative 24 Hours to 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start23 Jan 2025
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Cerebrovascular AccidentStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhixin Huang, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758609
- Sponsor's protocol ID
- CHILL-ART
- Acronym
- CHILL-ART
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun W, Zhang X, Hu M, Ouyang D, Liu Y, Zhou L, Huang ZX; CHILL-ART Group. Catheter-Based Focal Hypothermia With Endovascular Reperfusion in Acute Anterior Circulation Large Artery Occlusion Stroke (CHILL-ART): A Randomized Controlled Trial Protocol. Stroke Vasc Interv Neurol. 2025 Dec 11;6(1):e002058. doi: 10.1161/SVIN.125.002058. eCollection 2026 Jan.
PubMed 41816520
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Hypothermia and Endovascular Recanalization for Acute Large Artery Occlusive Stroke-A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06758609
- Acronym / sponsor ID
- CHILL-ART / CHILL-ART
- Conditions
- Acute Cerebrovascular Accident, Acute Ischemic Stroke, Internal Carotid Artery, Middle Cerebral Artery Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Guangdong Second Provincial General HospitalUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 6 Jan 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 patients with acute anterior circulation large artery occlusion.
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 anterior circulation large artery occlusion. This study used a stratified randomization method, with participants randomly allocated in a 1:1 ratio by a central network randomization system to either the mechanical thrombectomy (MT) combined with arterial selective cooling infusion (intravenous recombinant tissue plasminogen activator) (hypothermia) group or the MT combined with normal saline infusion (normothermia) group (hereinafter referred to as the hypothermia group or normothermia group). Randomization was stratified by ASPECTS score (≥8 or <8) and age (≥75 years or <75 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group | Experimental | Procedure: Mechanical thrombectomy, Drug: 4°C saline infusionPatients 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 | Active comparator | Procedure: Mechanical thrombectomy, Drug: Normothermic saline infusionPatients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- Pre stroke mRS>1 score.
- There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
- NIHSS≤6 points.
- 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.
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 |
|---|---|---|
| Mechanical thrombectomyMechanical thrombectomy | Procedure or surgery | Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group, Mechanical thrombectomy combined with normothermic saline infusion (normothermia) group |
| 4°C saline infusionPatients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT). | Drug | Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group |
| Normothermic saline infusionPatients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT). | Drug | Mechanical thrombectomy combined with normothermic saline infusion (normothermia) group |
Primary outcome
Proportion of patients with modified Rankin Score 0-2 at 90 days.
Time frame: 90 days after procedure
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
5 secondary outcomes
Proportion of patients with modified Rankin Score 0-1 at 90 days
Time frame: 90 days after procedure
Successful reperfusion rate
Time frame: At the end of the operation
Cerebral infarction volume was measured by CT or magnetic resonance DWI 72 hours to 7 days after operation
Time frame: 72 hours to 7 days after procedure
Incidence of early neurological deterioration
Time frame: Within 24 hours after procedure
Rate of recurrent occlusion on MRA or CTA (postoperative 24 Hours to 7 Days)
Time frame: postoperative 24 Hours to 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Derived from this study: PubMed 41816520Sun W, Zhang X, Hu M, Ouyang D, Liu Y, Zhou L, Huang ZX; CHILL-ART Group. Catheter-Based Focal Hypothermia With Endovascular Reperfusion in Acute Anterior Circulation Large Artery Occlusion Stroke (CHILL-ART): A Randomized Controlled Trial Protocol. Stroke Vasc Interv Neurol. 2025 Dec 11;6(1):e002058. doi: 10.1161/SVIN.125.002058. eCollection 2026 Jan.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical thrombectomy, 4°C saline infusion and Normothermic saline infusion in people with Acute Cerebrovascular Accident and Acute Ischemic Stroke, run by Guangdong Second Provincial General Hospital at 1 site in China.
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 9 inclusion and 7 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: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 days after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06758609, which also lists 1 linked publication.
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 14 Oct 2026.