Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526429
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Local Ischemic Postconditioning in Acute Ischemic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RAPID Local Ischemic Postconditioning in Acute Ischemic Stroke pAtients receiVEd Successful Thrombectomy Reperfusion
Status:
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:
RAPID-SAVEI
Brief Summary:
This study aims to determine the safety and optimal dose of rapid local ischemic postconditioning in acute ischemic strokeAIS patients received successful thrombectomy reperfusion In this trial investigators will halt antegrade cerebral blood flow temporarily by the way of balloon guiding catheter BGC inflationdeflation in AIS patients immediately after revascularization It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration The optimal postconditioning intervention dose will be determined for further investigation
Detailed Description:
This will be an Bayesian Optimal Interval Phase III BOIN12 trial design to determine the safety and optimal dose of ischemic postconditioning intervention The BOIN12 design makes the decision of dose escalation and de-escalation by simultaneously taking account of toxicity and efficacy and it quantifies the desirability of a dose in terms of toxicity-efficacy trade off Under BOIN12 patients are adaptively assigned to the most desirable dose with the optimal toxicity-efficacy trade-off
Eligible patients are 18 years or older with symptomatic large vessel occluded LVO AIS treated with mechanical thrombectomy MT achieving successful reperfusion defined as modified thrombolysis in cerebral infarction mTICI score 2b or 3 Participants will receive balloon inflationdeflation at ipsilateral C1 segment of internal carotid artery ICA for the temporary occlusion of the antegrade blood flow
Six postconditioning intervention doses were adopted for blocking and restoration of blood blow This study will include 6 doses with the start dose set at dose 180 Dose 15 15s15s 5 cycles Dose 60 60s60s 4 cycles Dose 120 120s120s 4 cycles Dose 180 180s180s 4 cycles Dose 240 240s240s 4 cycles Dose 300 300s300s 4 cycles In this trial a maximum number of 60 participants will be enrolled with a cohort size of 5 and cohort number of 12 The maximum sample size of each dose is set at 20
The safety outcome within 7 days dose limiting toxicity DLT including any one of 1 malignant middle cerebral artery MCA infarction defined as midline shift 5 mm at the level of septum pellucidum or anisocoria attributable to herniation or death attributable to herniation 2 procedure related serious adverse eventsSAEs 3 other causally attributable SAEs Efficacy outcome was patients without clinically meaningful infarction growth at 72 hours defined as infarction growth10 mL from baseline to 72 hours
Eligible patients are 18 years or older with symptomatic large vessel occluded LVO AIS treated with mechanical thrombectomy MT achieving successful reperfusion defined as modified thrombolysis in cerebral infarction mTICI score 2b or 3 Participants will receive balloon inflationdeflation at ipsilateral C1 segment of internal carotid artery ICA for the temporary occlusion of the antegrade blood flow
Six postconditioning intervention doses were adopted for blocking and restoration of blood blow This study will include 6 doses with the start dose set at dose 180 Dose 15 15s15s 5 cycles Dose 60 60s60s 4 cycles Dose 120 120s120s 4 cycles Dose 180 180s180s 4 cycles Dose 240 240s240s 4 cycles Dose 300 300s300s 4 cycles In this trial a maximum number of 60 participants will be enrolled with a cohort size of 5 and cohort number of 12 The maximum sample size of each dose is set at 20
The safety outcome within 7 days dose limiting toxicity DLT including any one of 1 malignant middle cerebral artery MCA infarction defined as midline shift 5 mm at the level of septum pellucidum or anisocoria attributable to herniation or death attributable to herniation 2 procedure related serious adverse eventsSAEs 3 other causally attributable SAEs Efficacy outcome was patients without clinically meaningful infarction growth at 72 hours defined as infarction growth10 mL from baseline to 72 hours
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