[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632535":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ICO injection group","EXPERIMENTAL","RK-4 ICO injection through intracalvariosseous injection device (drilling 3 holes (each for 1-time administration) from the outer cranial plate without penetrating the inner plate), dose was given as 32 ug\u002Fkg once a day for 3 consecutive days, as well as standard treatment and management according to the related guidelines.",[13,14],"Device: RK-4 ICO injection","Other: Conventional treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"Conventional treatment group","SHAM_COMPARATOR","standard treatment and management according to related guidelines.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","RK-4 ICO injection","Patients included will be given skull outer plate drilling surgery and RK-4 ICO injection under local anesthesia and sedation using the intracalvariosseous injection device. The drilling and injection will be conducted once a day for 3 consecutive days.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional treatment","standard treatment and management according to related guidelines",[16,9],[32],{"name":33,"affiliation":34,"role":35},"Yilong Wang, PhD#MD","Beijing Tiantan Hospital, Capital Medical University, Beijing, China","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Yilong Wang, PhD+MD","CONTACT","18842627325","13261655100","yilong528@gmail.com",[44],{"facility":5,"status":26,"city":45,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":26},"Beijing","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","yilong Wang","Vice President of Beijing Tiantan Hospital","100632535","the-feasibility-and-safety-of-rk-4-injection-bypassing-blood-brain-barrier-in-the-treatment-of-acute-large-hemispheric-infarction-using-intracalvariosseous-injection-device-100632535",false,"NCT07514949","The Feasibility and Safety of RK-4 Injection Bypassing Blood-brain Barrier in the Treatment of Acute Large Hemispheric Infarction Using Intracalvariosseous Injection Device","SOLUTION-ICD","Inclusion Criteria:\n\n* 18≤Age≤80 years;\n* First stroke or complete self-care before the onset of current stroke (mRS 0-1);\n* Administration of drugs can be completed within 24h of the onset of signs and symptoms of neurological deficits (in patients with wake-up strokes or unwitnessed strokes, the time of onset is defined as the time of last normal presentation);\n* Clinical symptoms, signs and imaging diagnosis of cerebral infarction in the area supplied by the middle cerebral artery, together with the following features:\n\n  1. 16≤ NIHSS ≤32 points, and the sum of the scores of motor arm and motor leg is ≥6;\n  2. Imaging suggestive of core infarct area: apparent diffusion coefficient (ADC) values \\\u003C620×10-6mm2\u002Fs lesion volume on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequences or cerebral blood flow (CBF) \\\u003C30% of volume 70-300 ml on computed tomography perfusion imaging (CTP) or an Alberta Stroke Program Early CT Score (ASPECTS) of 0-6, with inconsistent findings, the investigator is required to make a reasoned judgement by taking into account all the information (scanning time, the imaging method that best responds to the size of infarct, etc.) and record it.\n* NIHSS score not improving or progressing after reperfusion therapy and total score still ≤32.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Complications with other cerebrovascular diseases meet one of the following conditions:\n\n  1. Complicated with acute cerebral hemorrhage and subarachnoid hemorrhage;\n  2. Complicated with acute posterior circulation cerebral infarction or severe posterior circulation stenosis (\\>70%);\n  3. Or imaging suggests that the area of cerebral infarction is involved bilaterally;\n  4. The cause of the TOAST classification was considered as intracranial artery dissection, vasculitis, moyamoya disease and other etiological types.\n* Hemorrhage transformation in the infarction area, hematoma area ≥30% of the infarction area, and has obvious space-occupying effect;\n* Presence of clinical signs of brain herniation formation, e.g., unilateral or bilateral pupil dilation and fixation; cerebral oedema-associated loss of consciousness (NIHSS 1a \\> 2 points), or other loss of brainstem reflexes in the judgement of the investigator, caused by cerebral oedema or cerebral herniation formation; or other signs of instability of vital signs that are difficult to control;\n* Craniotomy decompression was planned before randomization;\n* Refractory hypertension (systolic \\> 200mmHg or diastolic \\> 110mmHg) or hypotension (systolic \\\u003C 70mmHg or diastolic \\\u003C 50mmHg) that is difficult to control with medication;\n* Abnormal blood glucose before randomization (random venous blood glucose \\\u003C 2.8mmol\u002FL or \\> 23mmol\u002FL);\n* Presence of significant abnormal liver function markers or renal function markers prior to randomization; Note: Severe liver function abnormalities were defined as serum alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN). Significant renal insufficiency is defined as eGFR less than 60 mL\u002Fmin\u002F1.73 m2 (eGFR, calculated using the CKD-EPI formula)\n* Acute ST-elevation myocardial infarction (MI) and\u002For decompensated heart failure (meeting the New York College of Cardiology (NYHA) Heart function grades III and IV) within the past 3 months;\n* Presence of contraindications to intracalvariosseous injection, e.g., skull fracture in the last 3 months, skull infection, subdural\u002Fextradural hematoma, subcutaneous hematoma, skin or subcutaneous infection of the scalp, poorly displayed skull bone marrow niches;\n* Bleeding tendencies considered by the investigators to be detrimental to the procedure include, but are not limited to, platelet counts \\\u003C 100×109\u002FL, and the presence of clotting disorders such as hemophilia;\n* Presence of severe or very severe anemia (hemoglobin \\\u003C60 g\u002FL) at randomization;\n* Patients with severe respiratory diseases (severe chronic obstructive pulmonary disease, respiratory failure, etc.) should be corrected by intubation, tracheotomy, or ventilator;\n* The subjects were considered to have developed clinically significant serious infections, including severe local infections or systemic infections;\n* Diagnosed severe degenerative diseases of the central nervous system such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and severe dementia of all causes, or psychiatric disorders (e.g., schizophrenia, depression, etc.);\n* Subjects with a life expectancy of less than 3 months due to conditions not considered current by the investigators, such as tumors;\n* Known allergy to any component of investigational process therapy drugs and contrast agents;\n* Subjects who are pregnant, breastfeeding or have the possibility of becoming pregnant or plan to become pregnant;\n* Subjects are unable to comply with trial protocols or follow-up requirements;\n* Other circumstances deemed by the investigators to be unsuitable for enrollment (registration of reasons for inability to enroll is required);\n* Have participated in other interventional clinical trials.","ALL","18 Years","80 Years",{"count":69,"type":70},6,"ESTIMATED","INTERVENTIONAL",[73],"NA","A pilot study confirmed the feasibility and safety of neuroprotectant RK-4 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to investigate the feasibility and safety of neuroprotective agent RK-4 injection using intracalvariosseous injection device in patients with acute large hemispheric infarction (LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.",[76,77,78],"Stroke","Acute Ischemic Stroke","Blood-Brain Barrier",[80,81,82,83,84,85],"large hemispheric infarction","postsynaptic density protein 95 inhibitor","BBB-bypassing route","brain drug delivery","intracalvariosseous injection","intracalvariosseous injection device","NOT_YET_RECRUITING","2026-03-31",{"date":89,"type":90},"2026-04-07","ACTUAL",{"date":92,"type":70},"2026-04-15",{"date":94,"type":70},"2026-11-15",{"name":56,"class":6},1]