Rapid local brain-protecting postconditioning after thrombectomy for acute stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates rapid local ischemic postconditioning (RL-IPostC) applied immediately after successful endovascular thrombectomy in adults with acute anterior circulation large-vessel occlusion. The design combines Phase IIb dose selection with Phase III confirmatory testing to compare high-dose RL-IPostC, low-dose RL-IPostC, and no postconditioning, with randomization stratified by time since onset and baseline stroke severity. Outcome assessors are blinded to treatment, while treating physicians are not. The trial uses centralized randomization and an imaging core lab to support blinded outcome evaluation, aiming to determine whether RL-IPostC can reduce reperfusion injury and improve functional outcomes. The study is conducted at institutions led by Shanghai Jiao Tong University Affiliated Sixth People’s Hospital in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-85 years
2. Diagnosis of acute ischemic stroke
3. Pre-stroke mRS 0-1
4. Baseline NIHSS score ≥ 6
5. Time from symptom onset to start of endovascular procedure (puncture) \< 24 hours; onset time defined as "last known well" time
6. Imaging criteria: ASPECTS 3-5 on CT, or ASPECTS \> 5 with acute ischemic core volume (defined as rCBF \< 30% or ADC \< 620) ≥ 50 mL
7. Occlusion of the intracranial segment of the internal carotid artery or the middle cerebral artery (M1/M2), confirmed as the symptomatic culprit vessel
8. 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
9. Written informed consent signed by the patient or a legal representative

Exclusion Criteria:

1. Presence of stenosis (≥ 50%) in the ipsilateral middle cerebral artery, internal carotid artery, or common carotid artery proximal to the occlusion site
2. Multiple emboli across different circulations (simultaneous anterior and posterior circulation emboli, or simultaneous left and right anterior circulation emboli)
3. Evidence on CT of extensive cerebral edema, midline shift, significant mass effect, or signs of brain herniation
4. Presence of a life-threatening disease with a prognosis \< 6 months, making 3-month follow-up impossible
5. Severe psychiatric disorder or heart failure
6. Concurrent participation in another clinical drug or device study
7. Any other condition that, in the investigator's judgment, makes the subject unsuitable for this study

Where it's running

• Jiangshan Deng
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Yueqi Zhu, MD — Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Study coordinator: Yining Tao, MD
• Email: yiningtao1001@163.com
• Phone: 0086-021-64844183

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.