Status:
COMPLETED
Ischemic Postconditioning in Acute Stroke Patients Receiving Endovascular Thrombectomy
Lead Sponsor:
Tianjin Huanhu Hospital
Conditions:
Stroke Acute
Cytoprotection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Th...
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 alo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06967025
Start Date
September 12 2024
End Date
August 15 2025
Last Update
December 15 2025
Active Locations (1)
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1
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China, 300700