Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke
Key facts
- Where
- Barcelona, SpanyolországSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 89 years old?
Where in Spanyolország
- Vall d'Hebron University HospitalBarcelona, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hybernia Medical
- Trial code
- NCT06634303
- Record updated
- 2026. március 17.
- Original description
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.Read full original descriptionShow less
Hybernia Delta H (ΔH) Brain Cooling System for: Post-Mechanical Endovascular Cerebral Cooling
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.
Inclusion: 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; Pre-MT catheter angiogram shows target occlusion in intracranial ICA, M1 MCA, or M2 MCA; End of MT catheter angiogram shows achievement of moderate-to-complete reperfusion (modified Treatment in Cerebral Ischemia score or mTICI 2a-3).
Exclusion: Previous intracranial hemorrhage, AVM, neoplasm (except small meningioma), or vascular stent-implant; Coma or reduced level of consciousness prior to MT (NIHSS 1A>1); Post-reperfusion investigational therapy cannot be started within 150 min following pre-treatment CT or MR imaging; Pre-MT CT or MRI shows acute intracranial hemorrhage; Seizure between LKW and time of potential enrollment; Severe contrast allergy or absolute contraindication to iodinated contrast; Hypersensitivity to cold, i.e., history of cold-sensitive antibodies, Raynaud syndrome, or hepatitis C; Severe known renal impairment, i.e., requires renal replacement therapy (dialysis); Life expectancy <6 months due to pre-existing conditions such as severe heart or renal failure, cancer, etc; Hematocrit <33%; Presumed septic embolism, suspicion of bacterial endocarditis; Known pregnancy (in women with child-bearing potential); Body weight < 40kg; Patient not willing and able to participate in follow-up visits to day 90; Currently or within past 30 days participating in another investigational treatment study.