NCT07232082

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

Assessing Local Hypothermia and Endovascular Recanalization for Acute Stroke With a Large Core Infarction-A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 322 (estimated)
• Sponsor: First Affiliated Hospital of Wannan Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Stroke
• Large Ischemic Core

Interventions

Type	Name	Description
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 extracted within 2 minutes and infused at a rate of 30ml/min for 10 minutes through the intermediate catheter or guiding catheter placed in the internal carotid artery. Post-infusion, contrast-enhanced cerebral angiography using room temperature contrast agent is generally not recommended to dilute the local temperature.
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 300ml of saline will be extracted within 2 minutes and infused at a rate of 30ml/min for 10 minutes through the intermediate catheter or guiding catheter placed in the internal carotid artery.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-30
• Completion: 2027-04-07
• First posted: 2025-11-18
• Last updated: 2025-11-18