Clinical Trial

Combination of Hypothermia and Thrombectomy in Acute Stroke

Study acronym: COTTIS-2
Recruiting Phase 3
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Record status
This record was last updated January 6, 2025 (before its estimated March 18, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion. The main question it aims to answer is: does an additional cooling to 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed. Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-03-03.
Status change: Not Yet Recruiting → Recruiting 2025-01-02
Trial Details
NCT Number NCT06301412
Lead Sponsor University of Freiburg
Collaborators: European Union, E+E CRO consulting, Vienna, Austria, Center for Medical data science, University of Vienna, Austria
Conditions Ischemic Stroke, Large Vessel Occlusion, Endovascular Treatment
Enrollment 400 participants
Start Date 2024-07-07
Primary Completion 2026-03-18 (estimated)
Study Completion 2026-06-18 (estimated)
Updated on ClinicalTrials.gov 2025-01-06