CompletedNot Applicable

Local Ischemic Postconditioning in Acute Ischemic Stroke

China25 participantsStarted 2024-10-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years old * Presenting with symptoms and signs consistent with acute anterior circulation ischemic stroke * Pre-stroke modified Rankin Score 0-1 * Baseline National Institute of Health Stroke Scale (NIHSS) score≥6 * Endovascular treatment can be initiated (femoral puncture) within 24 hours from stroke onset (stroke onset time is defined as last known well time) * Occlusion of the intracranial internal carotid artery, or the middle cerebral artery (MCA) (M1 or M2) and is the culprit artery * Ischemic core volume is \< 70 ml, mismatch ratio is \>1.8 and mismatch volume is \>15 ml as determined by CT perfusion imaging * Embolism verified as the etiology of occluded artery and modified Thrombolysis in Cerebral Infarction Score (mTICI) 2b or 3 achieved after mechanical thrombectomy. * Time from CT perfusion to reperfusion \< 2 hours * Informed consent signed Exclusion Criteria: * Stenosis of the proximal middle cerebral artery, internal carotid artery, or common carotid artery (≥50%) of the culprit artery * Evidence of internal carotid artery lesion that precludes the access and application of balloon guide catheter * Multiple vascular embolism on different pathways (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion) * Pre ischemic stroke within past 3 months * The expected survival time is less than 6 months, could not be followed at 90 days (such as patient with malignant tumor) * Currently pregnant, mental disease, advanc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: within 7 days

Trial details

NCT IDNCT06526429

SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-04

View on ClinicalTrials.gov More Acute Ischemic Stroke trials