Phase
Condition
Occlusions
Thrombosis
Cerebral Ischemia
Treatment
NBO
Control
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age at least 18 years old;
Signs and symptoms are consistent with a new acute stroke, with low possibility ofstroke mimics (e.g., no sudden coma, prior seizure disorder, suspectedhypoglycemia);
No prior stroke in the last 3 months;
Time from stroke onset (last seen well) to randomization is within 9 hours;
(1) Baseline NIHSS score at 6 or more and Intracranial ICA or MCA-M1 or MCA-M2dominant occlusion, with or without tandem cervical carotid stenosis or tandemcervical occlusion, confirmed by preoperative CTA (or MRA, DSA) and consistent withsigns and symptoms; or (2) Baseline NIHSS score at 6 or more with a hyperdense MCAsign on non-contrast CT; or (3) Baseline NIHSS score at 12 or more;
NIHSS score 0 or 1 in the section of level of consciousness;
No significant pre-stroke disability (pre-stroke mRS 0--1);
ASPECTS at least 6 on non-contrast CT;
Patient is planned for transfer to a EVT-capable hospital for EVT;
Signed informed consent from the patient or the legally authorized representative (LAR).
Exclusion
Exclusion Criteria:
Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0),New York Heart Association (NYHA) Heart Failure Class III or IV, acute pulmonaryinfection or aspiration pneumonia, prior to enrollment;
Respiratory rate <= 10 or >= 30 breaths per minute;
Oxygen-dependence at baseline to maintain SaO2 > 95% or intubation at baseline;
Seizure at stroke onset;
Exhibiting symptoms of vomiting, or severe headache, or unconscious;
Rapidly improving neurological deficits or transient ischemic attack prior toconsent;
Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal;
Evidence of intracranial tumor (except small meningioma) or arteriovenousmalformation;
Woman of childbearing potential known to be pregnant or with a positive pregnancytest;
Life expectancy < 90 days due to comorbidity;
Unlikely to complete the 90-day follow-up;
Participating in another clinical treatment trial, or completed participation withinprior 30 days;
Receiving other cerebral protective agent (e.g., edaravone dexborneol,n-butylphthalide);
Evidence of acute intracranial hemorrhage on CT/MRI;
Significant mass effect with midline shift, defined as any deviation of midlinestructures such as the septum pellucidum, is observed on CT/MRI scans.
Study Design
Study Description
Connect with a study center
Xuanwu Hospital, Capital Medical University
Beijing, Beijing 100053
ChinaActive - Recruiting
The First People's Hospital of Qujing
Qujing, Yunnan 655000
ChinaActive - Recruiting
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