Clinical trial NCT06967025: Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy
Official title: Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy: Mechanistic Exploration Through a Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stroke Acute
Cytoprotection
Ischemic Conditioning
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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).

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.

Primary outcomes:
measure: Infarct volume growth
timeFrame: Difference between infarct volume at 48 (-12/+24) hours post-randomization and baseline.
Secondary outcomes:
measure: Final infarct volume
timeFrame: At 48 (-12/+24) hours post-randomization.
measure: Immediate postprocedural infarct volume
timeFrame: Within 2 hours post-randomization.
measure: Difference in modified Rankin Scale distribution
timeFrame: At 90 days post-randomization.
measure: Difference in modified Rankin Scale of 0-1
timeFrame: At 90 days post-randomization.
measure: Difference in modified Rankin Scale of 0-2
timeFrame: At 90 days post-randomization.
measure: Occurrence of early neurological improvement
timeFrame: within 24 hours post-randomization.
measure: Longitudinal Change of NIHSS Scores
timeFrame: At 24 hours, 3 days, and 5-7 days post-randomization or at discharge.
Other outcomes:
measure: Blood brain barrier permeability as measured by K-trans value using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)
timeFrame: At 48 (-12/+24) hours post-randomization.
measure: Multi-omics analysis of protein and metabolite quantitative changes using mass spectrometry-based proteomics and metabolomics
timeFrame: At 48 (-12/+24) hours post-randomization.
measure: Percentage of platelet-neutrophil aggregates (CD41+CD66b+ cells) measured by flow cytometry
timeFrame: Within 24 hours post-randomization.
measure: Percentage of activated platelets (CD41+CD62+ cells) measured by flow cytometry
timeFrame: Within 24 hours post-randomization.
measure: Percentage of activated neutrophils (CD11b+ cells) measured by flow cytometry
timeFrame: Within 24 hours post-randomization.
measure: R time (reaction time) measured by thromboelastogram (TEG)
timeFrame: Within 24 hours post-randomization.
measure: K time (clot kinetics) measured by thromboelastogram (TEG)
timeFrame: Within 24 hours post-randomization.
measure: Alpha angle measured by thromboelastogram (TEG)
timeFrame: Within 24 hours post-randomization.
measure: MA (maximum amplitude) measured by thromboelastogram (TEG)
timeFrame: Within 24 hours post-randomization.
measure: EPL (estimated percent lysis) measured by thromboelastogram (TEG)
timeFrame: Within 24 hours post-randomization.
measure: LY30 (lysis at 30 minutes) measured by thromboelastogram (TEG)
timeFrame: Within 24 hours post-randomization.
Locations:
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
References: