Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06307743
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-04
Brief Title:
Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke
Sponsor:
Shanghai Jiao Tong University Affiliated Sixth Peoples Hospital
Organization:
Shanghai Jiao Tong University Affiliated Sixth Peoples Hospital
Study Overview
Official Title:
A Multicenter Open Label Blind Endpoint Clinical Trial to Evaluate the Efficacy and Safety of Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke Patients Received Successful Thrombectomy Reperfusion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
RAPID-SAVE
Brief Summary:
The objective of this clinical trial is to determine whether rapid local ischemic postconditioning RL-IPostC is effective in preventing brain edema and safe in acute ischemic stroke AIS patients treated with mechanical thrombectomy In this trial researchers will block antegrade cerebral blood flow temporarily by the way of balloon inflationdeflation in AIS patients immediately after revascularization It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration Researchers will evaluate the protective role and safety of different duration of balloon inflationdeflation The optimal postconditioning intervention dose will be determined for further confirmative investigation
Detailed Description:
This will be an umbrella trial of testing the efficacy and safety of three postconditioning intervention doses It will be a prospective open-label blinded endpoint three-dose Bayesian Optimal Phase 2BOP2 design trial with interim efficacy and safety monitoring The maximum number of subjects for this trial is estimated as 135 patients Eligible patients are 18 years or older with symptomatic large vessel occluded LVO AIS treated with mechanical thrombectomy MT achieving successful reperfusion defined as mTICI score 2b or 3 Patients will receive 5 cycles of balloon inflationdeflation at ipsilateral C1 segment of internal carotid artery ICA for the temporary occlusion of the restoration of antegrade blood flow Three postconditioning intervention doses of 30s30s 60s60s and 180s180s were adopted for block and restore of blood blow The primary outcome is a favorable binary outcome defined as no clinically meaningful brain swelling from baseline to 24 hours and no clinically meaningful infarction growth from baseline to 24 hours and no causally attributable serious adverse events SAEs Its a composite outcome of efficacy and safety outcome Key secondary outcomes include efficacy outcome indicating no clinically meaningful brain swelling defined by cerebral spinal fluid CSF volume reduction5 mL from baseline to 24 hours and safety outcome indicating infarct volume growth10 mL from baseline to 24 hours or causally attributable SAEs Other secondary outcomes include change of brain net water uptake midline shift and functional outcome For each intervention dose we will perform the interim analyses following pre-defined optimized Bayesian rule for early stopping to make a gono-go decision when the number of enrolled patients reaches 10 20 30 The optimal intervention dose will be determined according to the number of patients reach the primary endpoints in different groups
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