Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy

Starting soon · Not applicable

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID: NCT07598799
Run by: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
People needed: 448
Starts: 2026-07-01
Expected to finish: 2029-05-30
Last updated by the study team: 2026-06-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18-85 years
Diagnosis of acute ischemic stroke
Pre-stroke mRS 0-1
Baseline NIHSS score ≥ 6
Time from symptom onset to start of endovascular procedure (puncture) < 24 hours; onset time defined as "last known well" time
Imaging criteria: ASPECTS 3-5 on CT, or ASPECTS > 5 with acute ischemic core volume (defined as rCBF < 30% or ADC < 620) ≥ 50 mL
Occlusion of the intracranial segment of the internal carotid artery or the middle cerebral artery (M1/M2), confirmed as the symptomatic culprit vessel
After thrombectomy, the culprit vessel is considered to be occluded by an embolus, and successful recanalization (mTICI 2b/3, i.e., ≥ 50% perfusion) is achieved
Written informed consent signed by the patient or a legal representative

You may not qualify if…

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
Severe psychiatric disorder or heart failure
Concurrent participation in another clinical drug or device study
Any other condition that, in the investigator's judgment, makes the subject unsuitable for this study

Full record on ClinicalTrials.gov

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