AzTrials
AzTrials

Acute Ischemic StrokePost-MECCNCT06634303

Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke

A study testing Brain cooling in people with Acute Ischemic Stroke, run by Hybernia Medical at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Brain cooling
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteSpain
Study dates
1 Jun 2025to 20 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Vall d'Hebron University Hospital

    Barcelona

Other trials in Spain

About this study

Official title: 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.

Being tested
Brain cooling
Keywords
Ischemic Stroke, Brain cooling, Cerebral Hypothermia, Neuroprotection, Mechanical Thrombectomy
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain coolingDevice

    Brain cooling intervention in acute ischemic stroke patients post mechanical thrombectomy

Study groups in NCT06634303
Study groupRoleWhat they receive
Post-Mechanical Cerebral CoolingExperimentalAcute ischemic stroke patients undergoing mechanical thrombectomy.
Receives: Device: Brain cooling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device Feasibility

    Completion of Brain Cooling over 30 minutes

    Measured: During the intervention

Secondary outcomes (10)

  1. Any Intracranial Hemorrhage

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

    Measured: Up to 7 days after the intervention

  2. Symptomatic Intracranial Hemorrhage

    Associated with NIHSS reduction of ≥4 points or death

    Measured: Up to 7 days after the intervention

  3. Serious Adverse Events

    Incidence of serious adverse device effect (SADE)

    Measured: Up to 7 days after the intervention

  4. Hypothermia Effect on Vasculature

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

    Measured: Up to 24 hours after the intervention

  5. Mortality

    Death

    Measured: Up to 3 months after the intervention

  6. Hospital Readmission

    Due to stroke

    Measured: Up to 3 months after the intervention

  7. Device Performance and Usability

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

    Measured: During the intervention

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

    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

    Measured: Pre-intervention

  9. Infarct Size

    Final infarct size/volume

    Measured: 3 days after the intervention and up to 7 days after the intervention

  10. Global Disability via modified Rankin Scale (mRS)

    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

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

    Measured: Month 1 and Month 3 after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start1 Jun 2025
  3. Primary completion1 Oct 2025
  4. Study completion20 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Fist-in-human investigational device study
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06634303
Sponsor's protocol ID
HM001
Acronym
Post-MECC
Status last verified
Nov 2025
First submitted
4 Oct 2024
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Mangla S, Choi JH, Barone FC, Novotney C, Libien J, Lin E, Pile-Spellman J. Endovascular external carotid artery occlusion for brain selective targeting: a cerebrovascular swine model. BMC Res Notes. 2015 Dec 21;8:808. doi: 10.1186/s13104-015-1714-7.

    PubMed 26689288

  • Dumitrascu OM, Lamb J, Lyden PD. Still cooling after all these years: Meta-analysis of pre-clinical trials of therapeutic hypothermia for acute ischemic stroke. J Cereb Blood Flow Metab. 2016 Jul;36(7):1157-64. doi: 10.1177/0271678X16645112. Epub 2016 Apr 18.

    PubMed 27089911

  • Wu C, Zhao W, An H, Wu L, Chen J, Hussain M, Ding Y, Li C, Wei W, Duan J, Wang C, Yang Q, Wu D, Liu L, Ji X. Safety, feasibility, and potential efficacy of intraarterial selective cooling infusion for stroke patients treated with mechanical thrombectomy. J Cereb Blood Flow Metab. 2018 Dec;38(12):2251-2260. doi: 10.1177/0271678X18790139. Epub 2018 Jul 18.

    PubMed 30019993

  • Wan Y, Tian H, Wang H, Wang D, Jiang H, Fang Q. Selective intraarterial hypothermia combined with mechanical thrombectomy for acute cerebral infarction based on microcatheter technology: A single-center, randomized, single-blind controlled study. Front Neurol. 2023 Feb 16;14:1039816. doi: 10.3389/fneur.2023.1039816. eCollection 2023.

    PubMed 36873429

  • Neimark MA, Konstas AA, Lee L, Laine AF, Pile-Spellman J, Choi J. Brain temperature changes during selective cooling with endovascular intracarotid cold saline infusion: simulation using human data fitted with an integrated mathematical model. J Neurointerv Surg. 2013 Mar;5(2):165-71. doi: 10.1136/neurintsurg-2011-010150. Epub 2012 Jan 22.

    PubMed 22270331

  • Choi JH, Pile-Spellman J. Reperfusion Changes After Stroke and Practical Approaches for Neuroprotection. Neuroimaging Clin N Am. 2018 Nov;28(4):663-682. doi: 10.1016/j.nic.2018.06.008.

    PubMed 30322601

  • Choi JH, Pile-Spellman J. Selective brain hypothermia. Handb Clin Neurol. 2018;157:839-852. doi: 10.1016/B978-0-444-64074-1.00052-5.

    PubMed 30459044

  • Choi JH, Poli S, Chen M, Nguyen TN, Saver JL, Matouk C, Pile-Spellman J. Selective Brain Hypothermia in Acute Ischemic Stroke: Reperfusion Without Reperfusion Injury. Front Neurol. 2020 Nov 13;11:594289. doi: 10.3389/fneur.2020.594289. eCollection 2020.

    PubMed 33281733

  • Konstas AA, Neimark MA, Laine AF, Pile-Spellman J. A theoretical model of selective cooling using intracarotid cold saline infusion in the human brain. J Appl Physiol (1985). 2007 Apr;102(4):1329-40. doi: 10.1152/japplphysiol.00805.2006. Epub 2006 Dec 14.

    PubMed 17170208

  • Choi JH, Marshall RS, Neimark MA, Konstas AA, Lin E, Chiang YT, Mast H, Rundek T, Mohr JP, Pile-Spellman J. Selective brain cooling with endovascular intracarotid infusion of cold saline: a pilot feasibility study. AJNR Am J Neuroradiol. 2010 May;31(5):928-34. doi: 10.3174/ajnr.A1961. Epub 2010 Jan 6.

    PubMed 20053807

Questions about this trial

What is this clinical trial studying?

A study testing Brain cooling in people with Acute Ischemic Stroke, run by Hybernia Medical at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Feasibility (time frame: During the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06634303, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in