Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634303
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Hybernia Medical Post-Mechanical Thrombectomy Cerebral Cooling in Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hybernia Delta H ΔH Brain Cooling System For Post-Mechanical Endovascular Cerebral Cooling
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Post-MECC
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 eg 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 strokeischemia 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 Medicals 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 performanceusability and clinical outcome
In this first-in-human investigational deivce study Hybernia Medicals 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 performanceusability and clinical outcome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None