Hybernia Delta H (ΔH) Brain Cooling System for: Post-Mechanical Endovascular Cerebral Cooling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Device Feasibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •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
研究组 & 干预措施
Post-Mechanical Cerebral Cooling
Acute ischemic stroke patients undergoing mechanical thrombectomy.
干预措施: Brain cooling (Device)
结局指标
主要结局
Device Feasibility
时间窗: During the intervention
Completion of Brain Cooling over 30 minutes
次要结局
- 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)
- Hospital Readmission(Up to 3 months after the intervention)
- Device Performance and Usability(During the intervention)
- Final modified Treatment in Cerebral Infarction (mTICI) score(Pre-intervention)
- Infarct Size(3 days after the intervention and up to 7 days after the intervention)
- Global Disability via modified Rankin Scale (mRS)(Month 1 and Month 3 after the intervention)