Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy

NCT06967025 | Completed Phase 2 DMC

• 1 other identifier: tjhh20249
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke Acute; Cytoprotection; Ischemic Conditioning

Outcome Measures

Primary Outcomes (1)

• Infarct volume growth

  Difference between infarct volume at 48 (-12/+24) hours post-randomization and baseline.

Secondary Outcomes (7)

• Final infarct volume

  At 48 (-12/+24) hours post-randomization.

• Immediate postprocedural infarct volume

  Within 2 hours post-randomization.

• Difference in modified Rankin Scale distribution

  At 90 days post-randomization.

• Difference in modified Rankin Scale of 0-1

  At 90 days post-randomization.

• Difference in modified Rankin Scale of 0-2

  At 90 days post-randomization.

Other Outcomes (11)

• Blood brain barrier permeability as measured by K-trans value using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)

  At 48 (-12/+24) hours post-randomization.

• Multi-omics analysis of protein and metabolite quantitative changes using mass spectrometry-based proteomics and metabolomics

  At 48 (-12/+24) hours post-randomization.

• Percentage of platelet-neutrophil aggregates (CD41+CD66b+ cells) measured by flow cytometry

  Within 24 hours post-randomization.

Study Arms (2)

Endovascular thrombectomy

ACTIVE COMPARATOR

Procedure: Endovascular Thrombectomy

Ischemic Postconditioning plus Endovascular thrombectomy

EXPERIMENTAL

Procedure: Ischemic Postconditioning

Interventions

Ischemic Postconditioning PROCEDURE

Ischemic Postconditioning will consist of 4 cycles of 2-minute cycles of balloon inflation (occlusion) followed by 2 minutes of deflation (reperfusion), and will be initiated immediately upon successful recanalization (eTICI 2b-3) using low pressure balloon in situ of the location of thrombus.

Ischemic Postconditioning plus Endovascular thrombectomy

Endovascular Thrombectomy PROCEDURE

Thrombectomy alone.

Endovascular thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300700, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 13, 2025
• Study Start: September 12, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: December 15, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)