Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study
Condition: Carotid Artery Diseases; Hypothermia; Stroke; Carotid Artery Plaque; Carotid Artery Stenosis; Cerebrovascular Accident
MeSH terms: Stroke; Carotid Stenosis; Carotid Artery Diseases; Hypothermia
Study type: Interventional

Summary: 
      Aim of the study is to determine whether endovascular systemic cooling to a target
      temperature of 34-35°C initiated before, and maintained during Carotid EndoArterectomy (CEA),
      is feasible and safe
    

Detailed description: 
      The study is based on the hypothesis that performing CEA during hypothermia substantially
      reduces the risk due to a potential, temporary hypoperfusion, associated with the surgical
      procedure.

      The rationale behind the study is based on the assumption that Carotid EndArterectomy (CEA),
      by removing local causes of downstream altered circulation, improves cerebral hemodynamics
      and provides an effective prevention of stroke and TIA. The intervention itself, however,
      causes immediate risk of stroke or death, and it is also an issue whether the temporary
      reduction of blood flow associated with clamping of the artery, during the surgical
      intervention, may trigger long-lasting brain tissue dysfunction.

      Mild hypothermia (34-35 °C) is probably the most effective approach to protect the brain from
      ischemic insults. Most of the supportive data were obtained in animal models of ischemia.
      Several phase II trials have shown safety and feasibility of cooling subjects with stroke, in
      the hours following onset of symptoms. Early interventions show the highest benefit.

      Eligible patients will initiate cooling 60-90 min before CEA with endovascular cooling (Zoll
      system) to the target 34-35°C (assessed by bladder thermometer). The Zoll IVTM system is an
      endovascular cooling system that consists of a control module (either CoolGard 3000 or
      Thermogard XP), a CoolGard start-up kit, an ICY catheter (either IC-3585 AE or IC-3585 CO or
      IC-3893 AE or IC-3893 CO), a catheter convenience kit for catheter insertion (CO models
      only), thermal probes and cables. All the devise component have CE mark. The Low temperature
      will be maintained during the CEA procedure, followed by gradual, passive, controlled
      rewarming (0.4 °C/h). Type of anaesthesia will be decided according to good clinical
      practice. The cooling procedure will be, therefore, carried out during the anaesthesia
      procedure required by the surgical intervention. There is a chance that the duration of the
      anaesthesia will be longer that required, but all the efforts will be undertaken to keep the
      anaesthesia time as short as if there were no cooling

      Clinical and instrumental evaluations will be carried out before and post intervention. Each
      evaluation will consist of physical examination, neuropsychological evaluation (MoCA test),
      blood tests and brain MRI or TC.

      Safety is evaluated on the basis of severe adverse event
    

Intervention name(s): endovascular cooling (Zoll system)
Intervention type(s): Device
Intervention description(s): The Zoll IVTM is an endovascular cooling system that consists of a control module (either CoolGard 3000 or Thermogard XP), a CoolGard start-up kit, and an ICY catheter (either IC-3585 AE or IC-3585).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: carotid endarterectomy; stroke; hypothermia; endovascular cooling