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Completed

NCT Number: NCT06634303

Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vall d'Hebron University Hospital

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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 criteria

  • Pre-MT CT or MRI shows acute intracranial hemorrhage.
  • Previous intracranial hemorrhage, AVM, neoplasm (except small meningioma), or vascular stent-implant
  • Coma or reduced level of consciousness prior to MT (NIHSS 1A>1)
  • 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
  • Hematocrit <33%
  • Severe known renal impairment, i.e., requires renal replacement therapy (dialysis).
  • Post-reperfusion investigational therapy cannot be started within 150 min following pre-treatment CT or MR imaging
  • 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.
  • Life expectancy <6 months due to pre-existing conditions such as severe heart or renal failure, cancer, etc.
  • Currently or within past 30 days participating in another investigational treatment study

Treatment and study plan

Brain Cooling

Device

Brain cooling intervention in acute ischemic stroke patients post mechanical thrombectomy

Primary outcomes

  1. Device Feasibility

    Time frame: During the intervention

    Completion of Brain Cooling over 30 minutes

Secondary outcomes

  1. Any Intracranial Hemorrhage

    Time frame: Up to 7 days after the intervention

    Any radiologic confirmed intracranial hemorrhage as detected on follow-up CT.

  2. Symptomatic Intracranial Hemorrhage

    Time frame: Up to 7 days after the intervention

    Associated with NIHSS reduction of ≥4 points or death

  3. Serious Adverse Events

    Time frame: Up to 7 days after the intervention

    Incidence of serious adverse device effect (SADE)

  4. Hypothermia Effect on Vasculature

    Time frame: Up to 24 hours after the intervention

    Hypothermia effect on vasculature, such as vasospasm on cerebral angiogram or follow-up CTA

  5. Mortality

    Time frame: Up to 3 months after the intervention

    Death

  6. Hospital Readmission

    Time frame: Up to 3 months after the intervention

    Due to stroke

  7. Device Performance and Usability

    Time frame: During the intervention

    • Device installation, setup, and use
    • Circuit performance
    • Cooling performance and accuracy
    • Correct trigger of alarms

  8. Final modified Treatment in Cerebral Infarction (mTICI) score

    Time frame: Pre-intervention

    Grade 0: no perfusion

    Grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion

    Grade 2 Grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory (e.g. in one major division of the middle cerebral artery (MCA) and its territory)

    Grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory (e.g. in two major divisions of the MCA and their territories)

    Grade 2c: near complete perfusion except for slow flow or distal emboli in a few distal cortical vessels

    Grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches

  9. Infarct Size

    Time frame: 3 days after the intervention and up to 7 days after the intervention

    Final infarct size/volume

  10. Global Disability via modified Rankin Scale (mRS)

    Time frame: Month 1 and Month 3 after the intervention

    mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.

    (0) No symptoms at all

    • No significant disability despite symptoms; able to carry out all usual duties and activities
    • Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • Moderate disability; requiring some help, but able to walk without assistance
    • Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • Dead

Other outcomes

  1. Time to Reperfusion

    Time frame: Pre-intervention

    Time from Symptom onset-to-Groin puncture and Time from CT-to-Puncture

  2. Reperfusion Time

    Time frame: Pre-intervention

    Time from Puncture-to-Reperfusion

Sponsors and collaborators

Lead sponsor

Hybernia Medical

Industry

Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

Registry information

Official study title

Hybernia Delta H (ΔH) Brain Cooling System for: Post-Mechanical Endovascular Cerebral Cooling

Acronym: Post-MECC

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 9, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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