Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke

NCT06634303 | Completed DMC FDA Device

• 1 other identifier: HM001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Ischemic Stroke; Brain cooling; Cerebral Hypothermia; Neuroprotection; Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Device Feasibility

  Completion of Brain Cooling over 30 minutes

  During the intervention

Secondary Outcomes (10)

• Any Intracranial Hemorrhage

  Up to 7 days after the intervention

• Symptomatic Intracranial Hemorrhage

  Up to 7 days after the intervention

• Serious Adverse Events

  Up to 7 days after the intervention

• Hypothermia Effect on Vasculature

  Up to 24 hours after the intervention

• Mortality

  Up to 3 months after the intervention

Other Outcomes (2)

• Time to Reperfusion

  Pre-intervention

• Reperfusion Time

  Pre-intervention

Study Arms (1)

Post-Mechanical Cerebral Cooling

EXPERIMENTAL

Acute ischemic stroke patients undergoing mechanical thrombectomy.

Device: Brain cooling

Interventions

Brain cooling DEVICE

Brain cooling intervention in acute ischemic stroke patients post mechanical thrombectomy

Post-Mechanical Cerebral Cooling

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hybernia Medical: lead
• Hospital Universitari Vall d'Hebron Research Institute: collaborator

Study Sites (1)

Vall d'Hebron University Hospital

Barcelona, Spain

Location

Related Publications (10)

• 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.

  PMID: 26689288 BACKGROUND

• 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.

  PMID: 27089911 BACKGROUND

• 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.

  PMID: 30019993 BACKGROUND

• 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.

  PMID: 36873429 BACKGROUND

• 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.

  PMID: 22270331 BACKGROUND

• 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.

  PMID: 30322601 BACKGROUND

• 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.

  PMID: 30459044 BACKGROUND

• 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.

  PMID: 33281733 BACKGROUND

• 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.

  PMID: 17170208 BACKGROUND

• 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.

  PMID: 20053807 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marc Ribo, MD, PhD

  Vall d'Hebron University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Fist-in-human investigational device study

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 9, 2024
• Study Start: June 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: February 20, 2026
• Last Updated: March 17, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)