The main goal of this study is to find out if a new, quick "brain rescue" procedure can help people recover better from a severe stroke caused by a large vessel occlusion.
When someone has this type of stroke, doctors often perform a procedure called an endovascular thrombectomy (EVT). In EVT, they thread a thin tube through a blood vessel up to the brain to remove the clot and restore blood flow. This is a highly effective treatment.
However, for some patients, suddenly restoring blood flow can cause additional, unexpected injury to the brain. This is called "reperfusion injury." This study tests a technique called rapid local ischemic postconditioning (RL-IPostC) that might prevent this extra damage. It's a very simple additional step performed immediately after the clot is successfully removed.
The doctor would briefly inflate and deflate a tiny balloon inside the proximal brain artery after recanalization, creating very short, controlled "pauses" in blood flow. This is believed to give brain cells a gentler "wake-up" call, helping them tolerate the return of oxygen-rich blood.
The study will test two different "doses" of this procedure (meaning different numbers of inflation/deflation cycles) against the standard care (no additional procedure).
Phase IIb (the first part): Which dose of RL-IPostC (high or low) is more promising for reducing early brain swelling (measured by whether the brain's midline has shifted less than 3 mm on a 24-hour scan)? Phase III (the main part): Using the best dose from Phase IIb, does RL-IPostC improve a patient's functional recovery three months later, specifically enabling them to walk and manage daily activities without help? A total of 288 participants who have had a large-vessel occlusion stroke and successful clot removal will be enrolled. If early results look promising but not quite conclusive, the study can increase the total number of participants up to 448 to get a clearer answer.
If successful, this study could identify a simple, low-cost add-on procedure to a standard stroke treatment that improves long-term recovery and quality of life for thousands of stroke patients. It's a potential new tool to protect the brain after blood flow is restored. This is a carefully designed study testing a gentle "on/off" blood flow technique right after clot removal, to see if it can reduce brain injury and help people walk and live more independently after a severe stroke.
Age 18-85 years
Diagnosis of acute ischemic stroke
Pre-stroke mRS 0-1
Baseline NIHSS score ≥ 6
Presence of stenosis (≥ 50%) in the ipsilateral middle cerebral artery, internal carotid artery, or common carotid artery proximal to the occlusion site
Multiple emboli across different circulations (simultaneous anterior and posterior circulation emboli, or simultaneous left and right anterior circulation emboli)
Evidence on CT of extensive cerebral edema, midline shift, significant mass effect, or signs of brain herniation
Presence of a life-threatening disease with a prognosis < 6 months, making 3-month follow-up impossible
Parallel
High-dose RL-IPostC
Procedure/SurgeryFor acute anterior circulation with large core ischemic stroke patients who achieve successful vessel recanalization (mTICI 2b/3) after thrombectomy, within 5 minutes, the balloon guide catheter (BGC) is positioned in the straight segment of the ipsilateral internal carotid artery at the C1-C2 level, avoiding the carotid sinus. Repetitive balloon inflations (2 minutes) to block blood flow followed by deflations (2 minutes) to restore blood flow (for 4 cycles) are performed. After the first BGC inflation, confirmation of antegrade flow blockade in the internal carotid artery is required. At the end of the cycle, angiography is performed to confirm vessel patency.
Low-dose RL-IPostC
Procedure/SurgeryFor acute anterior circulation with large core ischemic stroke patients who achieve successful vessel recanalization (mTICI 2b/3) after thrombectomy, within 5 minutes, the balloon guide catheter (BGC) is positioned in the straight segment of the ipsilateral internal carotid artery at the C1-C2 level, avoiding the carotid sinus. Repetitive balloon inflations (15 seconds) to block blood flow followed by deflations (15 seconds) to restore blood flow (for 5 cycles) are performed. After the first BGC inflation, confirmation of antegrade flow blockade in the internal carotid artery is required. At the end of the cycle, angiography is performed to confirm vessel patency.
Phase IIb: proportion of subjects without midline shift ( >3mm)
Midline shift was measured at the level of the translucent septum in the follow-up NCCT or MRI at 24 hours.
Phase III: Proportion of subjects with mRS 0-3 at 90 days.
The modified Rankin Scale (mRS) is a single-item, global outcome rating scale used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disorders. The mRS is a 7-level ordinal scale ranging from 0 to 6, where higher scores indicate greater disability. 0-No symptoms at all 1. No significant disability despite symptoms: able to carry out all usual duties and activities 2. Slight disability：unable to carry out all previous activities but able to look after own affairs without assistance 3. Moderate disability：require some help, but able to walk without assistance 4. Moderate severe disability：unable to walk without assistance, and unable to attend to own bodily needs without assistance 5. Severe disability：bedridden, incontinent, and require constant nursing care and attention 6. Death
Proportion of subjects with good outcome (mRS 0-2) at 90 days
The modified Rankin Scale (mRS) is a single-item, global outcome rating scale used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disorders. The mRS is a 7-level ordinal scale ranging from 0 to 6, where higher scores indicate greater disability. 0-No symptoms at all 1. No significant disability despite symptoms: able to carry out all usual duties and activities 2. Slight disability：unable to carry out all previous activities but able to look after own affairs without assistance 3. Moderate disability：require some help, but able to walk without assistance 4. Moderate severe disability：unable to walk without assistance, and unable to attend to own bodily needs without assistance 5. Severe disability：bedridden, incontinent, and require constant nursing care and attention 6. Death
Distribution of mRS at 90 days
The modified Rankin Scale (mRS) is a single-item, global outcome rating scale used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disorders. The mRS is a 7-level ordinal scale ranging from 0 to 6, where higher scores indicate greater disability. 0-No symptoms at all 1. No significant disability despite symptoms: able to carry out all usual duties and activities 2. Slight disability：unable to carry out all previous activities but able to look after own affairs without assistance 3. Moderate disability：require some help, but able to walk without assistance 4. Moderate severe disability：unable to walk without assistance, and unable to attend to own bodily needs without assistance 5. Severe disability：bedridden, incontinent, and require constant nursing care and attention 6. Death
Proportion of subjects with mRS 0-3 at 1 year
The modified Rankin Scale (mRS) is a single-item, global outcome rating scale used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disorders. The mRS is a 7-level ordinal scale ranging from 0 to 6, where higher scores indicate greater disability. 0-No symptoms at all 1. No significant disability despite symptoms: able to carry out all usual duties and activities 2. Slight disability：unable to carry out all previous activities but able to look after own affairs without assistance 3. Moderate disability：require some help, but able to walk without assistance 4. Moderate severe disability：unable to walk without assistance, and unable to attend to own bodily needs without assistance 5. Severe disability：bedridden, incontinent, and require constant nursing care and attention 6. Death
Proportion of subjects with mRS 0-2 at 1 year
The modified Rankin Scale (mRS) is a single-item, global outcome rating scale used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disorders. The mRS is a 7-level ordinal scale ranging from 0 to 6, where higher scores indicate greater disability. 0-No symptoms at all 1. No significant disability despite symptoms: able to carry out all usual duties and activities 2. Slight disability：unable to carry out all previous activities but able to look after own affairs without assistance 3. Moderate disability：require some help, but able to walk without assistance 4. Moderate severe disability：unable to walk without assistance, and unable to attend to own bodily needs without assistance 5. Severe disability：bedridden, incontinent, and require constant nursing care and attention 6. Death
Infarct volume at 24-72 hours post-randomization
Infarction based on DWI hyperintensity, if MRI unavailable, based on hypodensity on CT
Ratio of increase in infarct volume at 24-72 hours post-randomization compared to baseline infarct volume
Baseline core infarct defined as rCBF \< 30% or ADC \< 620. Infarction at 24-72 hours post-randomization is defined on DWI hyperintensity, if MRI unavailable, based on hypodensity on CT.
Change in net water uptake between 24-72 hours post-randomization and pre-procedure
Net water uptake (NWU) was quantified in early infarct at the time of admission and 24-72 hours follow-up CT imaging. The early hypoattenuate infarct core or mapping core lesion from CTP or NCCT was assessed by densitometric measurements (D ischemic). A mirrored region of interest (ROI) was placed within normal tissue of the contralateral hemisphere (D normal). Quantitative NWU was then calculated as NWU=1-(D ischemic/D normal). Subsequently, change in net water uptake was calculated as the difference in NWU between the follow-up NCCT and admission NCCT.
Change in CSF/intracranial volume ratio (∆CSF/ICV) between 24-72 hours post-randomization and pre-procedure.
Intracranial CSF volumes were obtained using an established work flow which included CT image normalization and brain extraction, registration of baseline CT to supratentorial brain mask, coregistration of follow-up CT to baseline supratentorial mask, and segmentation of CSF regions (sulci and ventricles) from cerebral hemispheres, after excluding any visibly infarcted tissue. Segmented CSF was divided into hemispheric volumes using the midlines from each registered slice. The hemispheric CSF ratio was calculated as the CSF volume in the stroke-affected hemisphere divided by the volume in the contralateral hemisphere. Intracranial volume (ICV) was calculated by measuring the total supratentorial region registered between serial CT scans. The CSF volume, hemispheric CSF ratio, and CSF/ICV ratio were recorded in both the follow-up CT and the admission CT. Changes in CSF volume (ΔCSF) and the ratio of CSF volume to ICV (∆CSF/ICV) from baseline to follow-up CT were also calculated.
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