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

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

Overview

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).

Interventions

• Other intra-arterial local therapeutic hypothermia
  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 extra
• 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 30

Primary outcome measures

• Proportion of patients with modified Rankin Score 0-2 at 90 days. [Time frame: 90±7 days after randomization]

Secondary outcome measures (7)

• 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]

Eligibility criteria

Inclusion criteria

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

• 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.

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07232082 · 20250913

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗