NCT06301412 Combination of Hypothermia and Thrombectomy in Acute Stroke
| NCT ID | NCT06301412 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Freiburg |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-07-07 |
| Primary Completion | 2026-03-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2024-07-07 with a primary completion date of 2026-03-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Pre-stroke modified Rankin Scale (mRS) 0-2 \[7-point scale rating from 0 (no symptoms) to 6 (dead)\] * Acute ischemic stroke with NIHSS \>5 * Intracranial occlusion of the M1 or M2 segment of the middle cerebral artery (MCA) or internal carotid artery (ICA) or tandem occlusion on CT-angiography or MR-angiography with indication for endovascular treatment: * Time window 0-24h: 1. Last seen normal to groin puncture \< 6h: native CT or MRI-DWI with ASPECTS \>5 2. Last seen normal to groin puncture 6-24h or unknown time window: significant mismatch imaging according to the eligibility criteria of the DEFUSE-3 trial * Infarct core \<70ml (DWI oder CBF\<30%) * Penumbra \> 15ml (Tmax \>6sec) * Ratio penumbra/core \>1.8 * with or without iv thrombolysis with rtPA Exclusion Criteria: * Patients with an intranasal obstruction that prevents complete insertion of the nasal cannula should not be treated with the RhinoChill system. * Known severe hemorrhagic diathesis (International Normalized Ratio (INR) \>3.0, partial thromboplastin time (PTT) \> 70s, platelet count \< 50.000/μl) * Brain trauma or neurovascular surgery/intervention \<3 months * Severe infection * Pregnant women or women of childbearing potential (women of childbearing potential with negative pregnancy test may be included) * Known cerebral vasculitis * Proof of bleeding in cerebral CT or MRI (cerebral microbleeds in MRI \[hypertensive or in the context of cerebral amyloid angiopathy\] is permitted). * Known life expectancy \< 6 months
Contact & Investigator
Juergen Bardutzky, Prof.
PRINCIPAL INVESTIGATOR
University of Freiburg, Department of Neurology, Germany
Frequently Asked Questions
Who can join the NCT06301412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06301412 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06301412 currently recruiting?
Yes, NCT06301412 is actively recruiting participants. Contact the research team at juergen.bardutzky@uniklinik-freiburg.de for enrollment information.
Where is the NCT06301412 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany.
Who is sponsoring the NCT06301412 clinical trial?
NCT06301412 is sponsored by University of Freiburg. The principal investigator is Juergen Bardutzky, Prof. at University of Freiburg, Department of Neurology, Germany. The trial plans to enroll 400 participants.
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