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. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Not applicable, Interventional, and Treatment
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 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. Researchers will evaluate the protective role and safety of different duration of balloon inflation/deflation. The optimal postconditioning intervention dose will be determined for further confirmative investigation.
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 2(BOP2) 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 inflation/deflation 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 30s/30s, 60s/60s and 180s/180s 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). It's 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 reduction≤5 mL from baseline to 24 hours and safety outcome indicating infarct volume growth>10 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 go/no-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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 135 is above 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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The RL-IPostC 30 protocol involved 5 cycles of blow block and restoration, each for 30 seconds.
Procedure: rapid local ischemic postconditioning
The RL-IPostC 60 protocol involved 5 cycles of blow block and restoration, each for 60 seconds.
Procedure: rapid local ischemic postconditioning
The RL-IPostC 180 protocol involved 5 cycles of blow block and restoration, each for 180 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.
Number of Participants without clinically meaningful cerebral swelling, significant increase in infarct volume from baseline and intervention-related serious adverse events.
No clinically meaningful cerebral swelling defined as volume reduction of cerebrospinal fluid ≤ 5 mL from baseline. No significant increase in infarct volume from baseline defined as an increase in infarct volume of ≤ 10 mL. Intervention-related serious adverse events defined as SAEs specifically related to RL-IPostC other than mechanical thrombectomy.
Time frame: 24 hours after procedure
Rate of participants without clinically meaningful cerebral swelling
No clinically meaningful brain swelling defined by CSF volume reduction≤5 mL from baseline to 24 hours.
Time frame: 24 hours after procedure
Rate of participants with significant increase in infarct volume from baseline or intervention-related serious adverse events.
Significant increase in infarct volume from baseline defined as an increase in infarct volume of more than 10 mL. Intervention-related serious adverse events defined as SAEs specifically related to RL-IPostC other than mechanical thrombectomy.
Time frame: 24 hours after procedure
Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours
Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours from baseline
Time frame: 72 hours after procedure
Change of net water uptake (∆NWU24) at 24 hours
Change of net water uptake (∆NWU24) at 24 hours from baseline
Time frame: 24 hours after procedure
Change of net water uptake (∆NWU72) at 72 hours
Change of net water uptake (∆NWU72) at 72 hours from baseline
Time frame: 72 hours after procedure
Midline shift at 24 hours
Distance of midline shift at 24 hours (in millimeters at the level of the septum pellucidum)
Time frame: 24 hours after procedure
Midline shift at 72 hours
Distance of midline shift at 72 hours (in millimeters at the level of the septum pellucidum)
Time frame: 72 hours after procedure
Change of NIHSS at 24 hours
Change of NIHSS at 24 hours from baseline
Time frame: 24 hours after procedure
Early therapeutic response to treatment
Decrease in the NIHSS score of ≥8 from baseline or an NIHSS score of 0 to 2 at 24 hours)
Time frame: 24 hours after procedure
Good outcome at 90 days
Proportion of mRS score of 0 to 2 at 90 days
Time frame: 90 days after procedure
Excellent outcome at 90 days
Proportion of mRS score of 0 to 1 at 90 days
Time frame: 90 days after procedure
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2024; primary completion for Jun 2025, 15 months later.
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 planned 15 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.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2024. 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