Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy

Tianjin Huanhu Hospital

Status and phase

Completed

Phase 2

Conditions

Stroke Acute

Cytoprotection

Ischemic Conditioning

Treatments

Procedure: Ischemic Postconditioning

Procedure: Endovascular Thrombectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06967025

tjhh20249

Details and patient eligibility

About

This clinical trial will evaluate whether on-site ischemic postconditioning (IPostC) improves outcomes in acute stroke patients receiving endovascular thrombectomy (EVT) and explore its mechanisms. The investigators aim to answer: (1) Is on-site IPostC effective compared to EVT alone? (2) What molecular markers and cellular pathways does on-site IPostC influence? Participants will be randomized to EVT alone or EVT+IPostC (4 cycles of 2-minute balloon occlusion/reperfusion). The investigators will assess infarct size, functional outcomes, biomarkers (e.g., multi-omics, ELISA, and clinical laboratory parameters), and safety (e.g., mortality, procedure-related complications).

Full description

This clinical trial is a single-center, prospective, blind endpoint, randomized -controlled trial. Randomization will be in a 1:1 ratio, Intervention Arm (EVT + on-site IPostC) or Control Arm (EVT alone) in up to a total of 60 patients (30 subjects in each arm). On-site IPostC will be initiated immediately upon successful recanalization (eTICI 2b-3) using low pressure balloon in situ of the location of thrombus, consisting of 4 cycles of 2-minute cycles of balloon inflation (occlusion) followed by 2 minutes of deflation (reperfusion).

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.