Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT07049692
Eligibility Criteria:
Inclusion Criteria:
* 18-75 years
* Patients presenting clinical manifestations of acute anterior circulation ischemic stroke (6-20 NIHSS points) who underwent endovascular thrombectomy
* Consciousness status (NIHSS 1a-1b items): 0-1 points
* Pre-stroke functional status (mRS score): 0-1
* Time from onset to randomization ≤ 2 weeks
* Patient or legal representative who signed the informed consent form
* Preoperative CT angiography or magnetic resonance angiography confirmed large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that was consistent with the symptoms and signs
* A lberta S troke P rogram E arly C T S core ≥ 6
Exclusion Criteria:
* Subjects with HBO contraindications or intolerance
* Postprocedural imaging identified either procedure-related subarachnoid hemorrhage or hemorrhagic transformation
* Based on the medical history, it is suspected that the cerebral embolism is caused by sepsis or infective endocarditis
* Expected lifespan \< 90 days
* Severe heart, liver and kidneys failure
* Pregnancy
* Hereditary or acquired bleeding tendency, deficiency of coagulation factors, recent use of oral anticoagulants with an international normalized ratio (INR) \> 3 or activated partial thromboplastin time (APTT) exceeding the normal value by more than 3 times
* Baseline platelet count \< 50×10 9/L
* Baseline blood glucose is less than 2.78 mmol/L or greater than 22.2 mmol/L.
* Unstable vital signs (heart rate ≤ 50 beats/min or ≥ 120 beats/min, oxygen saturation ≤ 90%, respiration ≥ 30 breaths/min or ≤ 10 breaths/min);
* Hypertension that cannot be controlled by medication: Systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;
* Suspected of having acute myocardial infarction;
* Currently involving in the research of other projects related to drugs or medical devices.
* CT or MRI scans revealed intracranial tumors (except for cerebellar meningiomas) and intracranial arteriovenous malformations.
* Based on the medical history and CT or MRI findings, a diagnosis of internal carotid artery dissection or aortic dissection is suspected;
* Based on the medical history and CT or MRI findings, cerebral vasculitis is suspected.
* Based on the clinical evidence of multiple vascular regions being occluded (either in the bilateral anterior circulation or anterior/posterior circulation) or bilateral infarction or multi-region infarction as detected by CT angiography or magnetic resonance angiography;
* CT or magnetic resonance imaging shows a significant midline shift effect (\> 0.5 cm);
* CT angiography or magnetic resonance angiography confirmed the presence of cerebral vasculitis or cerebral vasculitis syndrome;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07049692
Study Brief:
Protocol Section:
NCT07049692