A Phase 3 trial investigating combination hypothermia and thrombectomy in acute stroke patients with large vessel occlusion reached primary completion on 2026-03-18, having enrolled 400 participants.
Background
Acute ischemic stroke, often caused by a large vessel occlusion, is a leading cause of disability and mortality worldwide. Endovascular treatment, specifically mechanical thrombectomy, has become a standard of care for eligible patients, significantly improving outcomes by restoring blood flow to the brain. However, even after successful reperfusion, some patients still experience poor clinical outcomes due to reperfusion injury or ongoing ischemic damage. This trial aims to explore whether adding therapeutic hypothermia, a technique involving controlled body cooling, to standard endovascular treatment can further improve neurological outcomes for these patients. The central hypothesis is that cooling to 35°C might offer neuroprotection and reduce injury, thereby enhancing the benefit of vessel reopening.
Trial design
This Phase 3 clinical trial, titled "Combination of Hypothermia and Thrombectomy in Acute Stroke," enrolled 400 participants. The study focuses on patients diagnosed with Ischemic Stroke, specifically those with Large Vessel Occlusion who are candidates for Endovascular Treatment. The intervention involves immediate cooling using a noninvasive transnasal cooling technique (RhonoChill), maintaining a target temperature of 35°C for 6 hours after the vessel has been reopened through endovascular treatment, followed by slow rewarming. Researchers will compare the intervention group (hypothermia and endovascular treatment plus best medical treatment) to determine if this additional cooling results in a benefit on clinical outcome.
What this means
The primary completion of this Phase 3 trial marks a significant milestone in the investigation of combination hypothermia and thrombectomy for acute stroke. With data collection for the primary endpoint now concluded for 400 participants, the trial is moving towards data analysis. The results, once available, will be crucial for understanding whether the addition of therapeutic hypothermia to standard endovascular treatment can improve clinical outcomes for patients experiencing acute ischemic stroke with large vessel occlusion. These findings could potentially inform future treatment guidelines and offer a new therapeutic strategy for this patient population.
Source
Information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06301412, titled "Combination of Hypothermia and Thrombectomy in Acute Stroke," was updated on 2026-03-18 on clinicaltrials.gov.