CompletedNot Applicable

Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke

Spain8 participantsStarted 2025-06-01

Plain-language summary

Reducing the temperature of tissue or organs (hypothermia) produces a protective state, through multiple molecular mechanisms, against adverse effects that arise from disrupted organ blood flow, e.g. in acute ischemic stroke (AIS). AIS is often caused by a blood clot that occludes a brain artery which, in turn disrupts brain blood flow. In large vessel occlusions, the current standard includes mechanical thrombectomy (MT), a minimally-invasive procedure that aims at removing the clot via endovascular means. In this case, brain cooling can lead to protection (neuroprotection) not only from the adverse effects of stroke/ischemia itself, but also from complications arising from sudden re-opening of the blocked artery through primary treatment, MT. This potential complication of MT is called reperfusion injury. In this first-in-human investigational deivce study, Hybernia Medical's endovascular brain cooling system will be applied in acute ischemic stroke patients undergoing MT. Post-MT, selective brain hypothermia will be induced and maintained over 30 minutes. Endpoints of this study include, clinical safety, device performance/usability, and clinical outcome.

Who can participate

Age range18 Years – 89 Years

SexALL

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Inclusion criteria

✓. Age 18 to 89
✓. Informed signed consent obtained from patient or legally authorized representative
✓. Clinical symptoms consistent with acute ischemic stroke
✓. Pre-stroke modified Rankin Scale (mRS) score 0-1
✓. National Institute of Health Stroke Scale (NIHSS) ≥ 6
✓. Alberta Stroke Program Early CT Score (ASPECTS) score 5-10
✓. IV tissue plasminogen activator (tPA) or Tenecteplase (TNK) may be administered within 4.5h of last known well (LKW), if patient eligible
✓. Mechanical thrombectomy (MT) treatment performed with arterial puncture within 24h of LKW.

Exclusion criteria

✕. Pre-MT CT or MRI shows acute intracranial hemorrhage.
✕. Previous intracranial hemorrhage, AVM, neoplasm (except small meningioma), or vascular stent-implant

What they're measuring

Device Feasibility

Timeframe: During the intervention

Trial details

NCT IDNCT06634303

SponsorHybernia Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-01

View on ClinicalTrials.gov More Acute Ischemic Stroke trials