Improving outcomes in stroke patients with ischemic postconditioning during thrombectomy

Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy: Mechanistic Exploration Through a Randomized Controlled Pilot Trial

This study is testing if adding a special treatment called ischemic postconditioning during a procedure for stroke can help improve recovery and outcomes for patients.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Huanhu Hospital (other)
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06967025 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of on-site ischemic postconditioning (IPostC) in enhancing outcomes for acute stroke patients undergoing endovascular thrombectomy (EVT). Participants will be randomly assigned to receive either EVT alone or EVT combined with IPostC, which involves cycles of balloon occlusion and reperfusion. The study aims to assess infarct size, functional outcomes, and safety while exploring the molecular mechanisms influenced by IPostC. A total of 60 patients will be enrolled, with 30 in each treatment arm.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with acute ischemic stroke symptoms and specific eligibility criteria for EVT.

Not a fit: Patients who have severe adverse events related to thrombectomy or those with contraindications to the study device may not benefit.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for stroke patients undergoing thrombectomy.

How similar studies have performed: While the concept of ischemic conditioning has been explored, this specific approach in conjunction with EVT is novel and has not been extensively tested.

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.

Where this trial is running

Tianjin, Tianjin

• Tianjin Huanhu Hospital — Tianjin, Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Yongbo Xu, MD

Conditions: Stroke Acute, Cytoprotection, Ischemic Conditioning