Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke

Hybernia Medical8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Acute Ischemic Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Device Feasibility

Completion of Brain Cooling over 30 minutes

Time frame: During the intervention

Secondary Outcomes

Any Intracranial Hemorrhage

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

Time frame: Up to 7 days after the intervention

Symptomatic Intracranial Hemorrhage

Associated with NIHSS reduction of ≥4 points or death

Time frame: Up to 7 days after the intervention

Serious Adverse Events

Incidence of serious adverse device effect (SADE)

Time frame: Up to 7 days after the intervention

Hypothermia Effect on Vasculature

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

Time frame: Up to 24 hours after the intervention

Mortality

Death

Time frame: Up to 3 months after the intervention

Hospital Readmission

Due to stroke

Time frame: Up to 3 months after the intervention

Device Performance and Usability

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

Time frame: During the intervention

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

Time frame: Pre-intervention

Infarct Size

Final infarct size/volume

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

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

Time frame: Month 1 and Month 3 after the intervention

Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes