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

Not Applicable

Recruiting

• Conditions: Acute Cerebrovascular Accident; Acute Ischemic Stroke; Internal Carotid Artery; Middle Cerebral Artery Occlusion
• Interventions: Procedure: Mechanical thrombectomy; Drug: 4°C saline infusion; Drug: Normothermic saline infusion

• Registration Number: NCT06758609
• Lead Sponsor: Guangdong Second Provincial General Hospital

Brief 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.

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-03-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 262

Inclusion Criteria

1. Age ≥18 and ≤85 years old.
2. Symptoms of sudden focal or general neurological impairment.
3. There may be a causal relationship between vascular occlusion and nerve function defect.
4. Time from symptom onset to randomization ≤24h.
5. The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
6. According to the judgment of the clinician, the operation path is reasonable, and the operation and operation related instruments can reach the disease smoothly.
7. 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.
8. Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment).
9. The symptoms are aggravated by recurrent cerebral infarction in the same drainage basin and/or the pathogenesis is caused by decreased blood perfusion.

Exclusion Criteria

1. Pre stroke mRS>1 score.
2. There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
3. NIHSS≤6 points.
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group	Mechanical thrombectomy	Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group	4°C saline infusion	Patients 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	Mechanical thrombectomy	Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
Mechanical thrombectomy combined with normothermic saline infusion (normothermia) group	Normothermic saline infusion	Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).

Primary Outcome Measures

Name	Time	Method
Proportion of patients with modified Rankin Score 0-2 at 90 days.	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with modified Rankin Score 0-1 at 90 days	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.
Successful reperfusion rate	At the end of the operation	Successful reperfusion was indicated by modified Thrombolysis in Cerebral Infarction (mTICI) grade 2b or 3.
Cerebral infarction volume was measured by CT or magnetic resonance DWI 72 hours to 7 days after operation	72 hours to 7 days after procedure	Cerebral infarction volume was measured by CT or DWI 72 hours to 7 days after operation.
Rate of recurrent occlusion on MRA or CTA (postoperative 24 Hours to 7 Days)	postoperative 24 Hours to 7 Days	Recurrent occlusion was measured by MRA or CTA 24 hours to 7 days after operation.
Incidence of early neurological deterioration	Within 24 hours after procedure	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.

Trial Locations

Locations (1)

Guangdong Second Provincial General Hospital; 🇨🇳 Guangzhou, Guangdong, China