NCT06526429

Local Ischemic Postconditioning in Acute Ischemic Stroke

RAPID Local Ischemic Postconditioning in Acute Ischemic Stroke pAtients receiVEd Successful Thrombectomy Reperfusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine the safety and optimal dose of rapid local ischemic postconditioning in acute ischemic stroke(AIS) patients received successful thrombectomy reperfusion. In this trial, investigators will halt antegrade cerebral blood flow temporarily by the way of balloon guiding catheter (BGC) inflation/deflation 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 I/II (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 inflation/deflation 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: 15s/15s, 5 cycles; Dose 60: 60s/60s, 4 cycles; Dose 120: 120s/120s, 4 cycles; Dose 180: 180s/180s, 4 cycles; Dose 240: 240s/240s, 4 cycles; Dose 300: 300s/300s, 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 events(SAEs); 3) other causally attributable SAEs. Efficacy outcome was patients without clinically meaningful infarction growth at 72 hours (defined as infarction growth\<10 mL from baseline to 72 hours).

Conditions

• Acute Ischemic Stroke
• Mechanical Thrombectomy
• Ischemic Postconditioning
• Brain Edema
• Neuroprotection

Interventions

Type	Name	Description
PROCEDURE	rapid local ischemic postconditioning	Rapid local ischemic postconditioning (RL-IPostC) is performed immediately (within 5 minutes) after revascularization. A balloon guiding catheter (BGC) positioned on ipsilateral C1 segment of internal carotid artery is inflated and deflated for the temporary occlusion of the antegrade flow.

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-07-04
• Completion: 2025-07-20
• First posted: 2024-07-29
• Last updated: 2025-11-28

Locations

2 sites across 1 country: China