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NCT07598799Recruiting

Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy

Rapid Local Ischemic Postconditioning Following Successful Recanalization After Endovascular Thrombectomy in Large Ischemic Core Stroke

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
448 (estimated)
First submitted
14 May 2026
Start date
18 Oct 2026
Primary completion date
30 May 2028
Lead sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Diseases
Stroke
NCT number
NCT07598799

What you commit to

  • Study type: Interventional
  • Planned participants: 448
  • From 18 Oct 2026 to the primary completion date, 30 May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent participation in another clinical drug or device study

Other illness

  • Presence of a life-threatening disease with a prognosis \< 6 months, making 3-month follow-up impossible
  • Severe psychiatric disorder or heart failure
  • Any other condition that, in the investigator's judgment, makes the subject unsuitable for this study

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jiangshan Deng
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.