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New treatment option for Ischemic Stroke
Official title Combination of Hypothermia and Thrombectomy in Acute Stroke
ClinicalTrials.gov ID: NCT06301412
What this study is testing
- What it's testing
- 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 ?
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Time window 0-24h:
- Last seen normal to groin puncture \ 5
You likely can't join if
- 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
See the full eligibility 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:
- Last seen normal to groin puncture \ 5
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Freiburg im Breisgau, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Freiburg im Breisgau, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.