Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy

Launched by TIANJIN HUANHU HOSPITAL · May 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new technique called ischemic postconditioning (IPostC) to see if it helps improve outcomes for patients who have had an acute stroke and are undergoing a procedure called endovascular thrombectomy (EVT). EVT is a treatment that removes blood clots from the brain to restore blood flow. The researchers want to find out if adding IPostC, which involves briefly blocking and then restoring blood flow, can make a difference in recovery. They will compare two groups of participants: one group will receive EVT alone, while the other will get EVT along with IPostC. The study will look at various factors, including the size of brain damage, recovery progress, and safety.

To be eligible for this trial, participants must be at least 18 years old, have experienced specific stroke symptoms, and meet certain health criteria. They should also be willing to provide consent to participate. Participants can expect to be randomly assigned to one of the two treatment groups and will be monitored closely for their health and recovery following treatment. This trial is currently recruiting patients, and it aims to provide valuable insights into how IPostC might help improve outcomes for stroke patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The patient is ≥ 18 years of age.
• • The patient must have symptoms consistent with AIS (i.e. face drooping, arm weakness, speech difficulty, etc.) , with symptoms severity of baseline NIHSS ≥ 6 and beginning less than 24 hours prior to presentation at hospital.
• • Pre-stroke mRS ≤ 2.
• • Baseline ASPECTS ≥ 6.
• • Unilateral middle cerebral artery occlusion, and/or internal carotid artery occlusion.
• • The patient is eligible for EVT.
• • Successful recanalization achieved through EVT (eTICI 2b-3).
• • The patient is willing to provide written informed consent to participate in this clinical trial.
• Exclusion Criteria:
• • The interventionalist deems the study device unable to reach the target site.
• • Adverse events related to thrombectomy, such as contrast extravasation, vascular rupture/perforation, dissection, or embolization to a new territory, detected on post-thrombectomy angiography.
• • Stent placement performed in the M1 segment of the middle cerebral artery or the terminal segment of the internal carotid artery during thrombectomy.
• • Angioplasty of more than two cycles of balloon inflation/deflation.
• • The patient is experiencing cardiogenic shock, systolic blood pressure \[SBP\] \<100 mmHg, HR\>100 bpm and arterial oxygen saturation (pulse oximetry) \<92% without additional oxygen.
• • The patient has known history of Congestive Heart Failure, hepatic failure, end-stage kidney disease or severe renal failure (clearance \< 30ml/min/1.73m²).
• • The patient is febrile (temperature \> 37.5 °C) or has experienced an infection with fever in the last 5 days.
• • The patient has a known hypersensitivity or contraindication to aspirin, heparin, Clopidogrel, tirofiban, or sensitivity to contrast media, which cannot be adequately pre-medicated.
• • The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions.
• • The patient has a pre-AIS life expectancy of \<1 year due to underlying medical conditions or pre-existing co-morbidities.
• • The patient is currently enrolled in another investigational drug or device trial.
• • The patient is apprehensive about or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy.
• • The patient is a female who is known to be pregnant.
• • Other conditions deemed unsuitable for inclusion by the investigator.