Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke

NCT ID: NCT06634303

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Post-Mechanical Cerebral Cooling

Acute ischemic stroke patients undergoing mechanical thrombectomy.

Group Type: EXPERIMENTAL

Brain cooling

Intervention Type: DEVICE

Brain cooling intervention in acute ischemic stroke patients post mechanical thrombectomy

Interventions

Brain cooling

Brain cooling intervention in acute ischemic stroke patients post mechanical thrombectomy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 89

2. Informed signed consent obtained from patient or legally authorized representative

3. Clinical symptoms consistent with acute ischemic stroke

4. Pre-stroke modified Rankin Scale (mRS) score 0-1

5. National Institute of Health Stroke Scale (NIHSS) ≥ 6

6. Alberta Stroke Program Early CT Score (ASPECTS) score 5-10

7. IV tissue plasminogen activator (tPA) or Tenecteplase (TNK) may be administered within 4.5h of last known well (LKW), if patient eligible

8. Mechanical thrombectomy (MT) treatment performed with arterial puncture within 24h of LKW.

9. Pre-MT catheter angiogram shows target occlusion in intracranial ICA, M1 MCA, or M2 MCA

10. End of MT catheter angiogram shows achievement of moderate-to-complete reperfusion (modified Treatment in Cerebral Ischemia score or mTICI 2a-3)

Exclusion Criteria

1. Pre-MT CT or MRI shows acute intracranial hemorrhage.

2. Previous intracranial hemorrhage, AVM, neoplasm (except small meningioma), or vascular stent-implant

3. Coma or reduced level of consciousness prior to MT (NIHSS 1A>1)

4. Seizure between LKW and time of potential enrollment

5. Severe contrast allergy or absolute contraindication to iodinated contrast.

6. Hypersensitivity to cold, i.e., history of cold-sensitive antibodies, Raynaud syndrome, or hepatitis C

7. Hematocrit <33%

8. Severe known renal impairment, i.e., requires renal replacement therapy (dialysis).

9. Post-reperfusion investigational therapy cannot be started within 150 min following pre-treatment CT or MR imaging

10. Presumed septic embolism, suspicion of bacterial endocarditis.

11. Known pregnancy (in women with child-bearing potential)

12. Body weight < 40kg

13. Patient not willing and able to participate in follow-up visits to day 90.

14. Life expectancy <6 months due to pre-existing conditions such as severe heart or renal failure, cancer, etc.

15. Currently or within past 30 days participating in another investigational treatment study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: collaborator

Hybernia Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Ribo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron University Hospital

Locations

Vall d'Hebron University Hospital

Barcelona, , Spain

Countries

Spain

References

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 30459044 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Other Identifiers

HM001

Identifier Type: -

Identifier Source: org_study_id