An interventional study of rapid local ischemic postconditioning in Acute Ischemic Stroke, Mechanical Thrombectomy and Ischemic Postconditioning, sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Not applicable, Interventional, and Treatment
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.
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).
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 25 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Shanghai Jiao Tong University Affiliated Sixth People's Hospital is the lead sponsor of 40 studies on the registry; 22 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose 15 involved 5 cycles of blow block and restoration, each for15 seconds.
Procedure: rapid local ischemic postconditioning
Dose 60 involved 4 cycles of blow block and restoration, each for 60 seconds.
Procedure: rapid local ischemic postconditioning
Dose 120 involved 4 cycles of blow block and restoration, each for 120 seconds.
Procedure: rapid local ischemic postconditioning
Dose 180 involved 4 cycles of blow block and restoration, each for 180 seconds.
Procedure: rapid local ischemic postconditioning
Dose 240 involved 4 cycles of blow block and restoration, each for 240 seconds.
Procedure: rapid local ischemic postconditioning
Dose 300 involved 4 cycles of blow block and restoration, each for 300 seconds.
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.
Incidence of Treatment-Emergent Adverse Events
Treatment-Emergent Adverse Events including any one of below: 1. Malignant middle cerebral artery infarction defined as midline shift ≥5 mm at the level of septum pellucidum, or anisocoria attributable to herniation, or death attributable to herniation. 2. Complications related to ischemic postcondition intervention that require treatment including distal vascular embolism, local arterial dissection, and local vascular spasm at the intervention site of the internal carotid artery. 3. Other causally attributable serious adverse events (SAEs)
Time frame: within 7 days
Incidence of mitigation on infarction growth
Mitigation on infarction growth defined as infarction growth\<10 mL from baseline to 72 hours
Time frame: 72 hours after procedure
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2024 to primary completion in Jul 2025, 8 months.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 8 months is below that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital