An interventional study of hypothermia and thrombectomy in Stroke, Acute Ischemic, sponsored by Xinqiao Hospital of Chongqing. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Xinqiao Hospital of Chongqing · Not applicable, Interventional, and Treatment
Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic effect make it one of the most promising neuro-protection approach.
In recent years, hypothermia has been increasingly used to treat acute ischemic stroke. However, its role in acute ischemic stroke is unclear.
The objective of this trial is to investigate whether hypothermia combined with endovascular thrombectomy could add additional benefit without increasing the risk of adverse events such as pneumonia, intracerebral hemorrhage, and mortality.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xinqiao Hospital of Chongqing is the lead sponsor of 69 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 29, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in Hypothermia group received hypothermia combined with endovascular thrombectomy.
Procedure: hypothermia · Procedure: thrombectomy
Patients in Control group received endovascular thrombectomy alone.
Procedure: thrombectomy
In this trial, intra-arterial selective cooling infusion is used to reduce brain tissue temperature. After thrombectomy, a microcatheter was advanced to the segment between the C6 segment of the internal carotid artery and the proximal M1 segment of the middle cerebral artery. To achieve rapid targeted cooling of the ischemic cerebral region, 0-4℃ of pre-cooled normal saline was infused through the microcatheter using precision infusion pumps. The brain temperature is monitored continuously at the sigmoid sinus as a surrogate marker. Participants are assigned to one of four target cooling gradients (0.3 °C, 0.4 °C, 0.6 °C, or 1.0 °C) relative to their baseline sigmoid sinus temperature.
Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.
Modified Rankin scale score (mRS)
Modified Rankin scale score (mRS): scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
Time frame: 90 days post-randomization
Excellent outcome
Score of 0-1 on the modified Rankin scale
Time frame: 90 days post-randomization
Functional independence
Score of 0-2 on the modified Rankin scale
Time frame: 90 days post-randomization
Moderate outcome
Score of 0-3 on the modified Rankin scale
Time frame: 90 days post-randomization
Early neurological improvement
Compared with baseline NIHSS, the 72h NIHSS score is reduced by 8 points or more, or the 72h NIHSS is 0\~1 point
Time frame: 72 hours post-randomization
NIHSS score at 5 to 7 days or discharge
Time frame: 5 to 7 days after randomization or discharge
Successful reperfusion at final angiogram
Successful reperfusion was defined as grade 2b to 3 on the extended Thrombectomy in the Cerebral Ischemia system.
Time frame: At the end of angiography or procedure
Difference between baseline and within 48h after procedure of infarction core volume (ml)
Time frame: 48 hours post-randomization
Reperfusion on follow-up CT or MR angiography
Time frame: 48 hours post-randomization
Incidence of symptomatic intracranial hemorrhage (SICH)
using Heidelberg criteria to assess SICH
Time frame: 48 hours post-randomization
incidence of any intracranial hemorrhage (any ICH)
Time frame: 48 hours post-randomization
90-day mortality
Time frame: 90 days post-randomization
Difference of hematocrit between baseline and 24-hour post-randomization
Time frame: 24-hour post-randomization
Non-hemorrhagic serious adverse event rate
including pneumonia, respiratory failure, circulatory failure, cerebral herniation, secondary epilepsy, sepsis, renal failure, acute coronary syndrome, venous thrombosis, etc.
Time frame: 90 days post-randomization
Complications related to operation and device
vasospasm, arterial rupture, arterial dissection, vascular puncture point complications, etc.
Time frame: 90 days post-randomization
Other serious adverse events
Time frame: 90 days post-randomization
Plan to share: Yes — Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and Analytic Code will be shared after approval of a proposal from principal investigator 3 years after the trial results are revealed.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 3 years after the trial results are revealed.
Access criteria: after approval of a proposal from principal investigator
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Dec 2026, 36 months after the start.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 36 months is above that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
Completion moved once since we started tracking on Sep 25, 2026: Mar 2027 → Dec 2026, on Oct 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Xinqiao Hospital of Chongqing