Ignite Creation Date:
2024-07-17 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485427
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-22
Brief Title:
Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke
Sponsor:
Beijing Shijitan Hospital Capital Medical University
Organization:
Beijing Shijitan Hospital Capital Medical University
Study Overview
Official Title:
Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With Endovascular Thrombectomy in Acute Ischemic Stroke A Multicenter Randomized Controlled Subject- and Assessor-Blind Clinical Trials
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOCUS
Brief Summary:
This is a multicenter randomized controlled subject- and assessor-blinded clinical trial The research objective is to evaluate the safety and efficacy of selective intra-arterial cooling infusion combined with endovascular therapy in the treatment of acute anterior circulation large vessel occlusion stroke This trial aims to enroll 258 subjects Patients assigned to the control group will receive best medical management BMM and endovascular therapy EVT Those in the selective intra-arterial cooling infusion group IA-SCI group will undergo selective intra-arterial cold saline infusion in addition to BMM and EVT Subjects will be interviewed face-to-face at randomization 246 hours 486 hours after randomization 72 daysdischarge Telephone interviews face-to face interviews will be performed at 303 days and 907 days after randomization The primary outcome is the distribution of Modified Rankin Score at 907days after randomization
Detailed Description:
Acute ischemic stroke AIS is the leading cause of death and disability in China Randomized trials involving patients with acute stroke due to large-artery occlusion in the anterior circulation have shown a benefit of endovascular therapy EVT Although EVT achieves successful recanalization in over 80 of patients only 46 of patients are functionally independent mRS 0-2 after the intervention Therefore new ancillary therapeutic strategies are needed to further improve the clinical outcomes
Therapeutic systemic hypothermia has been suggested to be one such potential approach offering a viable neuroprotective strategy However several adverse events associated with the systematic hypothermia treatment have been reported Those offset the therapeutic benefits of systemic hypothermia Selective intra-arterial cooling infusion IA-SCI targets precisely the ischemic brain tissue with the infusion of hypothermic solutions This approach induces a state of mild hypothermia in the ischemic region without causing substantial drops in core body temperature thereby minimizing the incidence of systemic side effects Previous studies have shown that IA-SCI with cold saline combined with EVT in AIS is safe and feasible
Hence the investigators design a multicenter randomized controlled subject- and assessor-blinded clinical trial The objective of this trial is to further explore the safety and efficacy of selective intra-arterial cooling infusion combined with EVT in the treatment of acute anterior circulation large vessel occlusion stroke and 258 subjects will be enrolled Subjects assigned to the control group will receive best medical management BMM and endovascular therapy EVT Those in the selective intra-arterial cooling infusion group IA-SCI group will undergo selective intra-arterial cold saline infusion in addition to BMM and EVT Subjects will be interviewed face-to-face at randomization 246 hours 486 hours after randomization 72 daysdischarge Telephone interviews face-to face interviews will be performed at 303 days and 907 days after randomization The primary outcome is the distribution of Modified Rankin Score at 907days after randomization
Therapeutic systemic hypothermia has been suggested to be one such potential approach offering a viable neuroprotective strategy However several adverse events associated with the systematic hypothermia treatment have been reported Those offset the therapeutic benefits of systemic hypothermia Selective intra-arterial cooling infusion IA-SCI targets precisely the ischemic brain tissue with the infusion of hypothermic solutions This approach induces a state of mild hypothermia in the ischemic region without causing substantial drops in core body temperature thereby minimizing the incidence of systemic side effects Previous studies have shown that IA-SCI with cold saline combined with EVT in AIS is safe and feasible
Hence the investigators design a multicenter randomized controlled subject- and assessor-blinded clinical trial The objective of this trial is to further explore the safety and efficacy of selective intra-arterial cooling infusion combined with EVT in the treatment of acute anterior circulation large vessel occlusion stroke and 258 subjects will be enrolled Subjects assigned to the control group will receive best medical management BMM and endovascular therapy EVT Those in the selective intra-arterial cooling infusion group IA-SCI group will undergo selective intra-arterial cold saline infusion in addition to BMM and EVT Subjects will be interviewed face-to-face at randomization 246 hours 486 hours after randomization 72 daysdischarge Telephone interviews face-to face interviews will be performed at 303 days and 907 days after randomization The primary outcome is the distribution of Modified Rankin Score at 907days after randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None