Acute Ischemic StrokeNCT07896655
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
A study testing Mechanical thrombectomy, Normothermic saline infusion and 4°C saline infusion in people with Acute Ischemic Stroke and Basilar Artery Occlusion, run by Guangdong Second Provincial General Hospital at 2 sites in China.
Trial summary
This study will examine whether cooling part of the brain through a catheter after endovascular treatment improves recovery in adults with acute basilar artery occlusion, a type of severe stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Basilar Artery Occlusion
- What is being tested?
- Mechanical thrombectomy, Normothermic saline infusion and 4°C 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
- 818 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2026to Mar 2030
- 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
- Age ≥ 18 years;
- Sudden onset of focal or global neurological deficit symptoms;
- Emergency imaging (CTA, MRA, or DSA) prior to randomization confirms occlusion of the basilar artery or vertebral artery. In the case of vertebral artery occlusion, bidirectional blood flow to the basilar artery must be completely obstructed, accompanied by corresponding neurological deficit symptoms;
- EVT is initiated within 24 hours of symptom onset;
- The National Institutes of Health Stroke Scale (NIHSS) score is ≥10 before the start of the procedure;
- Pc-ASPECTS ≥3;
Show all 9Show fewer
- Pre-stroke mRS score of 0-1;
- Randomization Trigger Conditions:
- (1)Successful recanalization of the basilar artery after endovascular treatment; (2)Definition of successful recanalization: eTICI grade reaching 2b, 2c,or 3; 9.The patient or their legal guardian is able to understand the purpose of the trial, voluntarily participate and sign a written informed consent form, and is capable of undergoing clinical follow-up.
Who cannot join
- Hypothermia-specific contraindications： (1)Hypothermia: Baseline core body temperature (rectal) <36.0°C; (2)History of cryoglobulinemia, sickle cell anemia, or Raynaud's disease;
- High-risk cardiac factors:
- (1)Sick sinus syndrome (SSS); (2)Second-degree type II or third-degree atrioventricular block (without pacemaker implantation); (3)Baseline heart rate <50 bpm or QTc >500 ms; (4)History of severe heart failure (LVEF <30%); 3.Severe clinical status:
- Refractory shock: admission systolic blood pressure <90 mmHg requiring combined or high-dose vasopressors for maintenance;
- Pregnant or lactating women;
- Life expectancy <90 days (due to other fatal diseases); 4.Currently participating in other clinical trials; in the research or follow-up phase.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
Zhixin Huang, PhD, 8613607548156, hzxd6@163.com
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
Wen Sun, PhD, 8615050589620, sunwen_medneuro@163.com
About this study
Official title: Selective Intra-Arterial Hypothermia Combined With Endovascular Treatment for Acute Basilar Artery Occlusion (CHILL- BAO): A Multicenter, Prospective, Open-Label, Blinded-Endpoint, Randomized Controlled Trial
This study will examine whether cooling part of the brain through a catheter after endovascular treatment improves recovery in adults with acute basilar artery occlusion, a type of severe stroke. After blood flow has been successfully restored, 818 participants will be randomly assigned to receive either cold saline or room-temperature saline through an artery. The main outcome is the level of disability 90 days later, measured using the modified Rankin Scale. The study will also assess safety, including bleeding in the brain and other complications.
Read the detailed description
This is a multicenter, prospective, randomized, open-label trial with blinded outcome assessment. It will compare selective intra-arterial hypothermia with a room-temperature saline control in adults with acute basilar artery occlusion who achieve successful reperfusion after endovascular treatment. Randomization will occur after successful reperfusion is confirmed.
Participants will be assigned in a 1:1 ratio to one of two groups. The hypothermia group will receive 350 mL of 4°C normal saline through an intra-arterial catheter at a fixed rate of 30 mL/min. The control group will receive 350 mL of room-temperature normal saline (22-25°C) through the same arterial route and at the same rate. The planned enrollment is 818 participants.
The primary outcome is the distribution of modified Rankin Scale scores, from 0 (no symptoms) to 6 (death), at 90 days after randomization. This outcome will be evaluated using a shift analysis across the full scale. Outcome assessors will be unaware of group assignments. The study will also evaluate other functional outcomes and adverse events.
- Conditions
- Acute Ischemic Stroke, Basilar Artery Occlusion
- Being tested
- Mechanical thrombectomy, Normothermic saline infusion, 4°C saline infusion
- Keywords
- Acute basilar artery occlusion, Endovascular treatment, Selective intra-arterial hypothermia, Neuroprotection, Randomized controlled trial
- Medical subject headings
- Ischemic Stroke
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
Normothermic saline infusionDrug
Participants in the normothermia group will receive a total of 350 mL of room-temperature (22-25°C) normal saline by intra-arterial infusion following endovascular treatment (EVT), at the same fixed rate as the hypothermia group: 30 mL/min.
4°C saline infusionDrug
Following successful reperfusion with endovascular treatment (EVT), participants in the hypothermia group will receive a selective intra-arterial infusion of 350 mL of 4°C normal saline at a fixed rate of 30 mL/min. No dose escalation will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia group | Experimental | Following successful reperfusion with endovascular treatment (EVT), participants in the hypothermia group will receive a selective intra-arterial infusion of 350 mL of 4°C normal saline at a fixed rate of 30 mL/min. No dose escalation will be performed. Receives: Procedure: Mechanical thrombectomy; Drug: 4°C saline infusion |
| Normothermia group | Active comparator | Receive a total of 350 ml of room temperature (22-25°C) saline infusion based on EVT treatment; the infusion rate is the same as that of the hypothermia group 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.
Distribution of Modified Rankin Scale Scores at 90 Days
The distribution of modified Rankin Scale (mRS) scores at 90 (±7) days after randomization will be assessed across all seven categories (0-6) using a shift analysis. Scores range from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
Measured: 90 (±7) days after randomization
Secondary outcomes (7)
mortality at 90 (±7) days
All-cause mortality at 90 (±7) days after randomization.
Measured: 90 (±7) days after randomization
Independent ambulation
The proportion of participants with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
Measured: 90 (±7) days after randomization
Functional independence
The proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
Measured: 90 (±7) days after randomization
Excellent outcome
The proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90 (±7) days after randomization will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
Measured: 90 (±7) days after randomization
Quality of life score
Health-related quality of life at 90 (±7) days after randomization will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Index scores calculated using the Chinese value set range from -0.391 (the worst health state) to 1 (full health); higher scores indicate better health-related quality of life.
Measured: 90 (±7) days after randomization
Cerebral infarction volume
Cerebral infarction volume measured on CT or diffusion-weighted MRI obtained between 72 hours and 7 days after the procedure (MRI preferred).
Measured: Between 72 hours and 7 days after the procedure
Vascular Re-occlusion Rate
Proportion of participants with re-occlusion of the originally occluded artery or a distal vessel, assessed by CTA or MRA between 24 hours and 7 days after the procedure.
Measured: Between 24 hours and 7 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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
- None (open label)
- Enrolment
- 818 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China
- Responsible party
- Principal investigator, Zhixin Huang, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896655
- Sponsor's protocol ID
- CHILL- BAO
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary publication, together with a data dictionary, will be available upon reasonable request, subject to a data sharing agreement and ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Intra-Arterial Hypothermia Combined With Endovascular Treatment for Acute Basilar Artery Occlusion (CHILL- BAO): A Multicenter, Prospective, Open-Label, Blinded-Endpoint, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07896655
- Acronym / sponsor ID
- CHILL- BAO
- Conditions
- Acute Ischemic Stroke, Basilar Artery Occlusion
- Keywords
- Acute basilar artery occlusion, Endovascular treatment, Selective intra-arterial hypothermia, Neuroprotection, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 818 participants (estimated)
- Lead sponsor
- Guangdong Second Provincial General HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 27 Oct 2026 (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.
This study will examine whether cooling part of the brain through a catheter after endovascular treatment improves recovery in adults with acute basilar artery occlusion, a type of severe stroke. After blood flow has been successfully restored, 818 participants will be randomly assigned to receive either cold saline or room-temperature saline through an artery. The main outcome is the level of disability 90 days later, measured using the modified Rankin Scale. The study will also assess safety, including bleeding in the brain and other complications.
Detailed description
This is a multicenter, prospective, randomized, open-label trial with blinded outcome assessment. It will compare selective intra-arterial hypothermia with a room-temperature saline control in adults with acute basilar artery occlusion who achieve successful reperfusion after endovascular treatment. Randomization will occur after successful reperfusion is confirmed.
Participants will be assigned in a 1:1 ratio to one of two groups. The hypothermia group will receive 350 mL of 4°C normal saline through an intra-arterial catheter at a fixed rate of 30 mL/min. The control group will receive 350 mL of room-temperature normal saline (22-25°C) through the same arterial route and at the same rate. The planned enrollment is 818 participants.
The primary outcome is the distribution of modified Rankin Scale scores, from 0 (no symptoms) to 6 (death), at 90 days after randomization. This outcome will be evaluated using a shift analysis across the full scale. Outcome assessors will be unaware of group assignments. The study will also evaluate other functional outcomes and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermia group | Experimental | Procedure: Mechanical thrombectomy, Drug: 4°C saline infusionFollowing successful reperfusion with endovascular treatment (EVT), participants in the hypothermia group will receive a selective intra-arterial infusion of 350 mL of 4°C normal saline at a fixed rate of 30 mL/min. No dose escalation will be performed. |
| Normothermia group | Active comparator | Procedure: Mechanical thrombectomy, Drug: Normothermic saline infusionReceive a total of 350 ml of room temperature (22-25°C) saline infusion based on EVT treatment; the infusion rate is the same as that of the hypothermia group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years;
- Sudden onset of focal or global neurological deficit symptoms;
- Emergency imaging (CTA, MRA, or DSA) prior to randomization confirms occlusion of the basilar artery or vertebral artery. In the case of vertebral artery occlusion, bidirectional blood flow to the basilar artery must be completely obstructed, accompanied by corresponding neurological deficit symptoms;
- EVT is initiated within 24 hours of symptom onset;
- The National Institutes of Health Stroke Scale (NIHSS) score is ≥10 before the start of the procedure;
Key exclusion criteria (6 listed)
- Hypothermia-specific contraindications： (1)Hypothermia: Baseline core body temperature (rectal) <36.0°C; (2)History of cryoglobulinemia, sickle cell anemia, or Raynaud's disease;
- High-risk cardiac factors:
- (1)Sick sinus syndrome (SSS); (2)Second-degree type II or third-degree atrioventricular block (without pacemaker implantation); (3)Baseline heart rate <50 bpm or QTc >500 ms; (4)History of severe heart failure (LVEF <30%); 3.Severe clinical status:
- Refractory shock: admission systolic blood pressure <90 mmHg requiring combined or high-dose vasopressors for maintenance;
- Pregnant or lactating women;
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 | Hypothermia group, Normothermia group |
| Normothermic saline infusionParticipants in the normothermia group will receive a total of 350 mL of room-temperature (22-25°C) normal saline by intra-arterial infusion following endovascular treatment (EVT), at the same fixed rate as the hypothermia group: 30 mL/min. | Drug | Normothermia group |
| 4°C saline infusionFollowing successful reperfusion with endovascular treatment (EVT), participants in the hypothermia group will receive a selective intra-arterial infusion of 350 mL of 4°C normal saline at a fixed rate of 30 mL/min. No dose escalation will be performed. | Drug | Hypothermia group |
Primary outcome
Distribution of Modified Rankin Scale Scores at 90 Days
Time frame: 90 (±7) days after randomization
The distribution of modified Rankin Scale (mRS) scores at 90 (±7) days after randomization will be assessed across all seven categories (0-6) using a shift analysis. Scores range from 0 (no symptoms) to 6 (death); lower scores indicate less disability.
7 secondary outcomes
mortality at 90 (±7) days
Time frame: 90 (±7) days after randomization
Independent ambulation
Time frame: 90 (±7) days after randomization
Functional independence
Time frame: 90 (±7) days after randomization
Excellent outcome
Time frame: 90 (±7) days after randomization
Quality of life score
Time frame: 90 (±7) days after randomization
Cerebral infarction volume
Time frame: Between 72 hours and 7 days after the procedure
Vascular Re-occlusion Rate
Time frame: Between 24 hours and 7 days after the procedure
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 6 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the primary publication, together with a data dictionary, will be available upon reasonable request, subject to a data sharing agreement and ethics approval.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical thrombectomy, Normothermic saline infusion and 4°C saline infusion in people with Acute Ischemic Stroke and Basilar Artery Occlusion, run by Guangdong Second Provincial General Hospital at 2 sites 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 6 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Zhixin Huang, PhD (8613607548156, hzxd6@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Modified Rankin Scale Scores 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 6 Nov 2026.