[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-ischemic-stroke-ais\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-ischemic-stroke-ais":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,47,70,106,132,166,193,221,245,267,287,318,344,373,394,419],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100601171","study-to-collect-real-world-performance-and-safety-data-on-penumbra-system-in-population-with-acute-ischemic-stroke-ais-100601171",false,"NCT07107022","Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).","i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®","i-RISE","Inclusion Criteria:\n\n* I.1. Patient age 18-75 years\n* I.2. Pre-stroke mRS 0-1\n* I.3. Patients experiencing acute ischemic stroke who are eligible for mechanical thrombectomy using the Penumbra System\n* I.4. Frontline treatment with Penumbra System\n* I.5. Signed informed consent per Institution Review Board\u002FEthics Committee\n\nExclusion Criteria:\n\n* E.1. Alberta Stroke Program Early CT Score (ASPECTS) ≤6 (for anterior circulation strokes)\n* E.2. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days\n* E.3. Currently participating in an investigational (drug, device, etc.) clinical trial that will influence the endovascular procedure or acute treatment of the patient. Patients in secondary prevention, observational, natural history, and\u002For\n* epidemiological studies are eligible.\n* E.4. Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study","ALL","18 Years","75 Years",{"count":21,"type":22},200,"ESTIMATED","OBSERVATIONAL","The primary objective of this study is to collect real-world performance and safety data on the Penumbra System in a patient population with acute ischemic stroke (AIS)",[26],"Acute Ischemic Stroke (AIS)",[28,29,30,31,32,33],"Penumbra System","Thrombectomy","Penumbra ENGINE®","mechanical thrombectomy","Neuro Thrombectomy","Neurovascular Catheters","RECRUITING","2026-06-05",{"date":37,"type":38},"2026-06-08","ACTUAL",{"date":40,"type":38},"2025-11-01",{"date":42,"type":22},"2028-04",{"name":44,"class":45},"Penumbra Inc.","INDUSTRY",10,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100629160","acute-ischemic-stroke-involves-significant-inflammatory-response-this-prospective-cohort-study-evaluates-the-predictive-value-of-monocyte--neutrophil--and-leukocyte-to-albumin-ratios-for-stroke-severity-and-functional-outcome-using-nihss-at-admission-and-modified-rankin-scale-during-follow-up-100629160","NCT07471061","Acute Ischemic Stroke Involves Significant Inflammatory Response. This Prospective Cohort Study Evaluates the Predictive Value of Monocyte-, Neutrophil-, and Leukocyte-to-albumin Ratios for Stroke Severity and Functional Outcome Using NIHSS at Admission and Modified Rankin Scale During Follow-up.","Predictive Utility of Monocyte-to-Albumin Neutrophil to Albumin and Total Leukocytic Count-to-Albumin Ratios in Ischemic Stroke. A Cohort Study","ALARMS","Inclusion Criteria:\n\n* Adult patients (≥ 18 years old) admitted with a diagnosis of acute ischemic stroke confirmed by brain imaging (CT or MRI).\n* Admission within a defined time window from stroke onset (e.g., within 48 hours) to capture acute inflammatory response.\n* Availability of complete blood count (CBC) with differential and serum -albumin levels at admission.\n* Informed consent obtained from the patient or their legal representative.\n\nExclusion Criteria:\n\n* Patients with hemorrhagic stroke or transient ischemic attack (TIA).\n* Patients with previous history of ischemic stroke.\n* Patients who accepted intravenous thrombolysis (IV tPA) and or mechanical thrombectomy.\n* Pre-existing inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease) that could influence monocyte count or albumin levels.\n* Active infections (bacterial, viral, fungal) at admission.\n* Severe liver or kidney disease affecting albumin synthesis or catabolism.\n* Hematological disorders affecting white blood cell counts. ⚫ Patients on immunosuppressive therapy or corticosteroids.\n* Patients with known malignancy\n* Lack of complete blood count (CBC) with differential and serum albumin levels at admission.\n* Patients who received blood transfusions before blood sampling.\n* Patients with other acute severe medical conditions that significantly impact inflammatory markers (e.g., sepsis, major trauma).",{"count":56,"type":22},60,"Acute Ischemic Stroke is a leading cause of mortality and long-term disability worldwide. Increasing evidence suggests that systemic inflammation plays a significant role in the pathophysiology and progression of ischemic brain injury. Recently, several inflammatory biomarkers derived from routine laboratory tests have been investigated as potential predictors of stroke severity and clinical outcome.\n\nThis prospective cohort study aims to evaluate the predictive utility of the monocyte-to-albumin ratio, neutrophil-to-albumin ratio, and total leukocytic count-to-albumin ratio in patients with acute ischemic stroke. These indices combine inflammatory cell counts with serum albumin levels and may reflect both systemic inflammatory status and nutritional condition.\n\nStroke severity will be assessed at admission using the NIH Stroke Scale, while functional outcome will be evaluated during follow-up using the Modified Rankin Scale. The study aims to determine whether these simple and readily available biomarkers can serve as reliable predictors of stroke severity and prognosis in patients with acute ischemic stroke.",[26],"NOT_YET_RECRUITING","2026-03-13",{"date":62,"type":38},"2026-03-17",{"date":64,"type":22},"2026-04-01",{"date":66,"type":22},"2026-10-01",{"name":68,"class":69},"Sohag University","OTHER",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100628792","phase-4-pcsk9-inhibitor-for-intracranial-atherosclerosis-related-acute-ischemic-stroke-100628792","NCT07466251","PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke","PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (PISTIAS-3): a Randomized, Double-blind, Placebo-controlled Trial","PISTIAS-3","Inclusion Criteria:\n\n* Age \\>=30 and \\\u003C=80;2.Acute ischemic stroke within 72 hours of onset (as determined by CT\u002FMRI in conjunction with neurological deficit symptoms)\n* Acute ischemic stroke within 72 hours of onset (diagnosed by CT\u002FMRI in conjunction with neurological deficit symptoms)\n* NIHSS score of 4-25 at admission\n* Imaging studies (CTA\u002FDSA\u002FMRA) support intracranial atherosclerosis as the cause of stroke, meeting one of the following criteria: i. The culprit vessel exhibits intracranial atherosclerotic stenosis (ICAS) with a narrowing degree of 50-99%; ii. The culprit vessel exhibits intracranial atherosclerotic occlusion (ICAS-LVO), with successful recanalization achieved via mechanical thrombectomy (immediate expanded thrombolysis in cerebral infarction \\[eTICI\\] grade 2b50-3)\n* Informed consent signed\n\nExclusion Criteria:\n\n* Non-atherosclerotic intracranial arterial stenosis (such as arterial dissection, Moyamoya disease, systemic vasculitis, etc.)\n* Any identifiable source of cardiogenic embolism (such as atrial fibrillation, mechanical valves, left ventricular thrombus, patent foramen ovale, etc.)\n* Imaging findings and clinical presentation suggest that the primary pathophysiology of this event is more consistent with cerebral small vessel disease (e.g., perforator artery occlusion\u002Flacunar infarction)\n* Pre-existing disability prior to this ischemic event (modified Rankin Scale ≥ 2 points)\n* CT or MRI findings suggest extensive cerebral infarction (e.g., ASPECTS score \\\u003C 6 or infarct volume ≥ 70 ml)\n* Has undergone or is scheduled to undergo a vascular stent implantation procedure within the next three months\n* Any intracranial hemorrhage occurring within 3 months prior to enrollment;\n* Intracranial tumors, cerebral aneurysms, or arteriovenous malformations that are assessed as having indications for interventional treatment\n* Severe active bleeding tendency or coagulation disorder\n* Severe dysfunction of vital organs such as the heart, liver, and kidneys\n* Received PCSK9 monoclonal antibody inhibitor therapy within 1 month prior to enrollment or PCSK9 siRNA inhibitor therapy within 6 months prior to enrollment\n* A clear contraindication to statins or a history of intolerance to them\n* Pregnancy, breastfeeding, or planning pregnancy;14.Currently participating in another study","30 Years","80 Years",{"count":81,"type":22},1212,"INTERVENTIONAL",[84],"PHASE4","This study is a prospective, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate whether early administration of PCSK9 inhibitors can effectively improve functional outcomes at 90 days in patients with ischemic stroke (AIS) associated with intracranial atherosclerotic stenosis (ICAS), primarily assessed using the modified Rankin Scale at 90 days.",[87,88,89],"Acute Ischemic Stroke AIS","Intracranial Atherosclerosis ICAS","Atherosclerotic Plaque",[91,92,93,94,95],"Intracranial Atherosclerosis","intracranial artery stenosis","atherosclerotic plaque","PCSK9 inhibitor","Recaticimab","2026-03-11",{"date":98,"type":38},"2026-03-12",{"date":100,"type":22},"2026-09-01",{"date":102,"type":22},"2029-12-31",{"name":104,"class":69},"Peking Union Medical College Hospital",19,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":82,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100596943","one-stop-management-for-a-swift-initiation-of-endovascular-therapy-100596943","NCT07052045","One-Stop manaGemEnT For A Swift Initiation of Endovascular Therapy","One-Stop manaGemEnT For A Swift Initiation of Endovascular Therapy - An International, Multicenter, Pragmatic Randomized Controlled Trial (GET-FAST","GET-FAST","Inclusion Criteria:\n\n* Symptoms suggestive of an acute ischemic stroke caused by a large or medium vessel occlusion as defined by a National Institute of Health Stroke Scale (NIHSS) Score of ≥ 10 points\n* Patient presents directly to the treating hospital (mothership patient) within 4.5 hours of last seen well (LSW)\n* Age ≥ 18 years\n* Patient was independent in daily activities prior to the stroke (pre stroke modified Rankin Scale of 0 - 2)\n* Endovascular treatment team available (Neurologist, Interventionist, Anesthesiologist, Nursery, Technicians)\n* Informed Consent as documented by signature or fulfilling the criteria for emergency consent procedures\n\nExclusion Criteria:\n\n* Severe comorbidities, which will likely prevent improvement or follow-up\n* In-hospital stroke\n* Clinical symptoms suggestive of intracranial hemorrhage (deterioration of patient during transport, vomiting or depressed consciousness)\n* Strong suspicion of functional neurological symptom disorder \u002F conversion disorder\n* Hemodynamically unstable patients who require advanced vital support\n* Angiography room occupied by other procedure",{"count":115,"type":22},390,[117],"NA","Stroke, especially acute ischemic stroke (AIS) caused by a blocked blood vessel in the brain, is a leading cause of death and long-term disability. When the blockage is in a large blood vessel, a procedure called endovascular therapy (EVT)-where the clot is removed using a catheter-is highly effective. However, the sooner EVT is done, the better the outcome for the patient.\n\nResearch has shown that delays between arriving at the hospital and starting EVT (called door-to-groin time) significantly reduce the chances of recovery. For example, reducing this time by just 15 minutes can mean 20 more patients (out of 1,000 treated) going home instead of to a care facility. Even a 10-minute improvement can result in over 100 extra days of independent living for patients and save more than $10,000 in healthcare costs per patient.\n\nTo reduce these delays, hospitals have improved stroke workflows. In the current standard approach, patients suspected of having a stroke are taken first to a CT scan room to confirm the diagnosis, and then, if a treatable occlusion is found, to a separate room for EVT. This usually takes around 60-70 minutes.\n\nHowever, moving patients between rooms takes time. A new approach called \"One-Stop management\" could solve this. In this method, both the brain scan and the EVT procedure are done in one room-the angiography suite-using special imaging tools called flat panel CT (FDCT) and FDCT angiography (FDCT-A).\n\nA previous study with 230 patients showed that One-Stop management is possible and saves time. But there's a challenge: the decision to follow the One-Stop pathway is made before a clear diagnosis is available. That's important because not all strokes benefit from EVT. Severe stroke symptoms (measured by a score called NIHSS ≥10) can come from:\n\n* A large or medium vessel blockage (which EVT can treat),\n* A small vessel blockage, or\n* A bleed in the brain (hemorrhage). Only the first group benefits from EVT. About 85% of patients with severe symptoms fall into this category. The rest-about 15%-would not benefit, and there are concerns that FDCT might be slightly less accurate than regular CT in diagnosing these types of strokes. So, we need to test whether One-Stop management is safe and effective for all patients, not just those with treatable blockages.\n\nTo do this, the GET-FAST trial will compare the One-Stop approach to the standard two-room process. Patients will be randomly assigned to one of the two strategies. Importantly, this randomization won't affect their actual treatment-everyone will still receive the best care according to current medical guidelines. The main endpoint for the evaluation of the One-Stop approach will be long-term (at 90 days) disability and dependency in daily life as measured with the modified Rankin Scale (mRS).\n\nThis study will include all patients as they were assigned, regardless of what type of stroke they actually had. This is called an \"intention-to-treat\" analysis, and it provides the most reliable measure of the overall impact of One-Stop management.\n\nAnother key aspect of the trial is that any CE-certified imaging system already used in hospitals can be used for the One-Stop process-no specific brand or model is required. This makes the results more applicable to real-world hospital settings.\n\nIf GET-FAST proves that One-Stop management leads to better patient outcomes, this could transform how stroke care is delivered. More patients could return to independent living, and fewer would require long-term care -leading to major reductions in healthcare costs. For example, even a one-point improvement on a common stroke disability scale (mRS) can triple the savings in lifetime care costs.",[120,87,121],"Stroke Acute","Hemorrhagic Stroke, Intracerebral","2026-01-15",{"date":124,"type":38},"2026-01-20",{"date":126,"type":38},"2025-12-02",{"date":128,"type":22},"2028-11-01",{"name":130,"class":69},"Prof. Dr. Jan Liman",2,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":141,"studyType":23,"phases":4,"briefSummary":142,"conditions":143,"keywords":152,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100617119","cardiological-interventions-and-acute-stroke-treatment-study-100617119","NCT07314476","CardioLogical Interventions and Acute strOke Treatment sTudy","CLOT","Inclusion Criteria:\n\n* acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria;\n* stroke with evidence of CT\u002FMRI DWI\u002FFLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h;\n* interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks);\n* written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).\n\nExclusion Criteria:\n\n* Stroke-like symptoms due primarily to another non-ischemic\u002Fhemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc);\n* Spontaneous and post traumatic hemorrhagic stroke or spontaneous\u002Fpost-traumatic subarachnoid hemorrhage or subdural hematoma;\n* AciuImpossibility to achieve written informed consent",{"count":140,"type":22},400,"180 Days","The study aims to investigate characteristics and prognosis of ischemic stroke cases following cardiological interventions, focusing on the effectiveness and safety of acute ischemic stroke treatments.",[87,144,145,146,147,148,149,150,151],"Stroke Treatment","PCI Patients","Aortic Valve Replacement","Transcatheter Aortic Valve Replacement (TAVR)","Mitral Valve Repair","Mitral Valve Replacement","Left Atrial Appendage Closure","Transcatheter Pulmonary Valve Replacement (TPVR)",[153,154,155],"acute ischemic stroke","acute ischemic stroke treatments","cardiological intervention","2026-01-04",{"date":158,"type":38},"2026-01-07",{"date":160,"type":22},"2026-01",{"date":162,"type":22},"2028-12",{"name":164,"class":69},"University of L'Aquila",1,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":176,"studyType":23,"phases":4,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":165},"100532271","prospective-registry-of-endovascular-thrombectomy-for-extra-large-ischemic-stroke-100532271","NCT06210633","Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke","XL STROKE: A Nationwide Prospective Registry of Endovascular Thrombectomy for Extra-large Ischemic Stroke With Large Vessel Occlusion","XL-STROKE","Inclusion Criteria:\n\nClinical inclusion criteria\n\n1. Age ≥18 years;\n2. Presenting with acute ischemic stroke within 24 hours of time from last known well;\n3. The patient or patient's representative signs a written informed consent form before enrollment.\n\nNeuroimaging inclusion criteria\n\n1. Occlusion of internal carotid artery, or the middle cerebral artery M1 or M2 segments confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography;\n2. The baseline ASPECTS is 0 to 2 based on NCCT or diffusion weighted imaging, or cerebral extra-large ischemic core volume ≥85ml (defined as relative cerebral blood flow \\\u003C30% on CT perfusion or an apparent diffusion coefficient \\\u003C620×10\\^-6 mm2\u002Fs on MRI).\n\nExclusion criteria\n\n1. CT or MRI evidence of acute intracranial hemorrhage;\n2. Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;\n3. Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;\n4. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;\n5. Any terminal illness with life expectancy less than 6 months;\n6. Participation in other clinical treatment trials.",{"count":175,"type":22},1000,"3 Months","Since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, five randomized controlled trials (ANGEL-ASPECT \\[Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core\\], LASTE \\[LArge Stroke Therapy Evaluation\\], RESCUE-Japan LIMIT \\[The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial\\], SELECT 2 \\[Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke\\], and TENSION \\[The Efficacy and Safety of Thrombectomy in Stroke with extended lesion and extended time window\\]) demonstrated the efficacy and safety of thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score \\[ASPECTS\\] ≥3 or infarct core \\\u003C100ml). Patients with extra-large infarct core (ASPECTS score of 2 or less) were excluded from these trials. Therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. The XL STROKE registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke.",[26,179],"Acute Ischemic Stroke From Large Vessel Occlusion",[181,182,183],"Acute ischemic stroke","large vessel occlusion","endovascular thrombectomy","2025-12-24",{"date":186,"type":38},"2025-12-31",{"date":188,"type":38},"2024-01-20",{"date":190,"type":22},"2026-03-31",{"name":192,"class":69},"Zhongming Qiu",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":82,"phases":203,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":4},"100611429","phase-2-bovis-calculus-stativus-treat-acute-cerebral-ischemic-stroke-with-impaired-consciousness-100611429","NCT07240467","Bovis Calculus Stativus Treat Acute Cerebral Ischemic Stroke With Impaired Consciousness","Safety and Efficacy of Bovis Calculus Stativus in the Treatment of Acute Cerebral Ischemic Stroke With Impaired Consciousness- A Multicenter, Prospective, Double-blind, Randomized Trial","ASCENT-BC","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Clinically diagnosed with ischemic cerebral infarction;\n* GCS score: 3-12;\n* Time from symptom onset to randomization ≤ 24 hours, including wake-up stroke or stroke without a witness; the time of symptom onset is defined as the \"last known well time\";\n* Pre-stroke mRS score of 0-1;\n* Head CT excludes intracranial hemorrhage or other non-ischemic pathologies;\n* The participant or legally authorized representative is capable of providing informed consent.\n\nExclusion Criteria:\n\n* Use of in BCS within 24 hours before treatment;\n* Known pregnancy or breastfeeding, or positive pregnancy test before randomization;\n* Allergy to BCS;\n* Impaired consciousness caused by other diseases, such as metabolic disorders (e.g., ketoacidosis), trauma, infectious diseases (e.g., pneumonia), neoplastic diseases (e.g., glioma), or toxic conditions (e.g., organophosphate poisoning);\n* Requiring or undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency (glomerular filtration rate \\\u003C30 mL\u002Fmin or serum creatinine \\>220 μmol\u002FL);\n* Expected survival time less than 6 months (e.g., due to malignancy, severe cardiopulmonary disease, etc.);\n* Participation in other interventional clinical studies that may affect outcome assessment;\n* Other conditions deemed by the investigator to make the patient unsuitable for participation or pose significant risks (e.g., inability to understand and\u002For comply with study procedures and\u002For follow-up due to mental illness, cognitive or emotional disorders).",{"count":202,"type":22},220,[204,205],"PHASE2","PHASE3","Acute ischemic stroke (AIS) is a severe and life-threatening condition, with 35% of AIS patients experiencing impaired consciousness upon admission within 24 hours of onset. Previous studies indicated that patients with impaired consciousness at the onset of stroke have a higher incidence of stroke-related complications, particularly cerebral edema and pneumonia, as well as higher in-hospital and three-month mortality rates. The etiology of impaired consciousness in AIS is complex: ischemic damage to reticular activating system of the brainstem can directly lead to cell necrosis and result in impaired consciousness. Furthermore, secondary pathological changes following AIS, such as excitatory amino acid toxicity, oxidative stress, free radical production, and cascading inflammatory responses, can indirectly worsen impaired consciousness. Therefore, impaired consciousness at the onset of AIS is the result of cellular damage under multiple pathophysiological mechanisms. Developing neuroprotective drugs with multiple targets is key to effectively improving adverse outcomes related to impaired consciousness in AIS. However, there is currently a lack of treatment specifically aimed at improving impaired consciousness at the onset of AIS.\n\nCultivated Bovine Bezoar (Bovis Calculus Stativus, BCS) combines the advantages of pharmacological similarity to natural bovine by adding components such as deoxycholic acid, cholic acid, and composite calcium bilirubin to fresh bovine bile. It is rich in various trace elements and amino acids and is a compound medication that can exert neuroprotective effects through multiple pathways and targets. In traditional Chinese medicine, it has long been used to treat various consciousness disorder-related diseases, including stroke. The various components of in vitro cultivated bezoar are also widely used in clinical research for various neurological diseases.The above evidence fully demonstrates that BCS is an optimal treatment for impaired consciousness in stroke.\n\nThe goal of this clinical trial is to learn if Bovis Calculus Stativus works to treat acute cerebral ischemic stroke with impaired consciousness. It will also learn about the safety of Bovis Calculus Stativus. The main questions it aims to answer are:\n\n1. Does Bovis Calculus Stativus treat and alleviate consciousness disorders in patients with acute cerebral infarction accompanied by impaired consciousness ？\n2. What medical problems do participants have when taking Bovis Calculus Stativus?\n\nResearchers will compare Bovis Calculus Stativus to a placebo (a look-alike substance that contains no drug) to see if Bovis Calculus Stativus works to treat acute cerebral ischemic stroke with impaired consciousness.\n\nParticipants will:\n\n1. receive treatment with Bovis Calculus Stativus (or placebo) for 5 days.\n2. Take an in-person or telephone follow-up within 90 days after the acute stroke.",[87,208],"Impaired Consciousness",[153,210,211],"impaired consciousness","Bovis Calculus Stativus","2025-12-10",{"date":214,"type":38},"2025-12-18",{"date":216,"type":22},"2025-12-15",{"date":218,"type":22},"2028-12-15",{"name":220,"class":69},"Xiang Luo",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":228,"targetDuration":4,"studyType":82,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":165},"100599401","phase-2-a-phase-iia-clinical-trial-to-evaluate-the-efficacy-and-safety-of-intravenous-infusion-of-huc-mscs-in-patients-with-ais-100599401","NCT07084012","A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS","A Phase IIa Randomized, Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in the Treatment of Acute Ischemic Stroke (AIS)","Inclusion Criteria:\n\n1. Age 18 to 75 years, inclusive, regardless of gender.\n2. Diagnosis of acute ischemic stroke (AIS).\n3. Onset time ≤ 72 hours.\n4. Anterior circulation cerebral infarction.\n5. Modified Rankin Scale (mRS) score ≤ 1 before the onset of this stroke.\n6. National Institutes of Health Stroke Scale (NIHSS) score between 8 and 20 (inclusive) at screening, and NIHSS item 1a (level of consciousness) score ≤ 1.\n7. The subject or their legal guardian has signed the informed consent form.\n\nExclusion Criteria:\n\n1. Planned or already undergone thrombolysis or thrombectomy for this stroke.\n2. History of epilepsy (excluding secondary epilepsy that does not currently require medication), Parkinson's disease, Alzheimer's disease, severe depression, or other diseases that the investigator deems would affect the subject's participation in the trial or the assessment of efficacy.\n3. Presence of intracranial hemorrhagic disease (e.g., intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural\u002Fepidural hematoma, etc.). If only petechial bleeding is present, the investigator may determine whether the subject is suitable for inclusion in the study.\n4. Computed tomography (CT) or magnetic resonance imaging (MRI) of the head showing a large ischemic area in the middle cerebral artery territory or midline shift greater than 1 cm on head CT\u002FMRI, and the investigator assesses a high likelihood of surgical intervention or poor prognosis.\n5. Presence of brain tumor or history of malignancy.\n6. Liver or kidney insufficiency during the screening period: Aspartate aminotransferase (AST) \\> 2.5 × upper limit of normal, alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal, estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m².\n7. History of severe cardiovascular disease, which the investigator deems unsuitable for participation in this clinical trial.\n8. Severe infection, including sepsis, septic shock, severe pneumonia, etc.\n9. Systemic corticosteroid ( \\> 10 mg\u002Fday prednisone equivalent) or immunosuppressive drug treatment within 14 days before receiving the investigational drug or during the trial.\n10. History of alcohol abuse within the past year (defined as an average of more than 2 units per day (1 unit = 10 mL ethanol, i.e., 1 unit = 200 mL of 5% alcohol beer or 25 mL of 40% alcohol spirits or 85 mL of 12% alcohol wine).\n11. Pregnant or breastfeeding women; or unwillingness to use reliable contraception (e.g., condoms) throughout the study period, or plans to donate sperm or eggs, or have plans for pregnancy.\n12. Participation in an interventional clinical trial within the past 3 months, or receipt of other cell therapy (excluding blood transfusion).\n13. Other situations in which the investigator deems the patient unsuitable for participation in this study (including but not limited to non-compliance with the principle of patient benefit, poor patient compliance, unacceptable laboratory abnormalities, etc.).",{"count":56,"type":22},[204],"This is a Phase IIa clinical trial with a three-arm design that utilizes randomization, double-blinding, and placebo control. The primary objective of this study is to evaluate the efficacy of single and multiple intravenous infusions of hUC-MSCs injection in patients with AIS. The secondary objective is to assess the safety and tolerability of single and multiple intravenous infusions of hUC-MSCs injection in patients with AIS. The exploratory objective is to investigate the pharmacokinetic and pharmacodynamic characteristics of hUC-MSCs injection in patients with AIS.",[87],[233,234,235],"hUC-MSCs","AIS,","Acute Ischemic Stroke","2025-09-23",{"date":238,"type":38},"2025-09-29",{"date":240,"type":38},"2025-08-27",{"date":242,"type":22},"2026-12-05",{"name":244,"class":45},"Shenzhen Wingor Biotechnology Co., Ltd.",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":82,"phases":254,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":263,"leadSponsor":265,"locationsCount":165},"100599507","balloon-guide-versus-conventional-guide-catheter-in-stroke-thrombectomy-100599507","NCT07085390","Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy","2Guide","Inclusion Criteria:\n\n* Age 18 years or older\n* Patient is undergoing a stroke thrombectomy procedure at the enrolling hospital\n* Patient or the legally authorized representative are able to provide signed informed cosent for the study\n* Patient is not enrolled in another clinical trial that may interfere with the results or interpretation of this study\n* Identification of a Large Vessel Occlusion (LVO) on imaging\n\nExclusion Criteria:\n\n* Lack of signed informed consent from the patient or legally authorized representative\n* Spontanous recanalization or any other reason in which the mechanical thrombectomy procedure would be terminated",{"count":253,"type":22},100,[117],"The purpose of this clinical trial is to study the two main types of approaches used in stroke thrombectomy and to investigate if one approach is more effective than the other, as this is currently not known. This study will be conducted in adults who have been diagnosed with an acute ischemic stroke and who are undergoing a thrombectomy for the treatment of their stroke. The main questions it aims to answer are:\n\n* Does the use of a balloon guide catheter versus a conventional guide catheter lower the time needed to restore blood flow in the blocked vessel in the brain\n* To help researchers better understand the technical, clinical, and procedural outcomes associated with using a balloon guide catheter versus a conventional guide catheter in stroke thrombectomy\n\nParticipants will be asked to\n\n* Share their medical history and imaging data that is collected as part of their routine medical care\n* Undergo a mechanical thrombectomy as part of their routine medical care\n* Answer some questions about their neurological functioning at 3 months (90 days) post hospitalization",[87],[258,29],"Ischemic Stroke","2025-09-15",{"date":261,"type":38},"2025-09-17",{"date":240,"type":38},{"date":264,"type":22},"2028-08",{"name":266,"class":69},"University of South Florida",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":82,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":283,"leadSponsor":285,"locationsCount":165},"100593203","phase-2-exploration-of-the-efficacy-and-mechanism-of-galantamine-an-extract-from-lycoris-aurea-in-treating-ischemic-stroke-100593203","NCT07003386","Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke","Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke Based on the Neurovascular Unit","Inclusion Criteria:\n\n* Aged \\> 18 years and \\\u003C 85 years, regardless of gender\n* Meeting the diagnostic criteria for ischemic stroke in Western medicine\n* Meeting the diagnostic criteria for stroke (Zhongfeng) in Traditional Chinese Medicine (TCM)\n* Diagnosis of acute ischemic stroke within 72h of symptom onset\n* A score of 4-25 points on the National Institute of Health Stroke Scale (NIHSS)\n* First onset of the disease, or no severe sequelae related to previous onset\n* The patient and their legal guardian voluntarily sign the informed consent form for the study\n\nExclusion Criteria:\n\n* Confirmed by cranial imaging examination to have diseases causing similar symptoms such as brain tumors, encephalitis, and brain abscesses; or confirmed to have hemorrhagic cerebral infarction,epidural hematoma,intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.\n* Patients with severe abnormalities of liver and kidney function (liver function: alanine aminotransferase \\[ALT\\] \\>2 times the upper limit of normal \\[ULN\\]; renal function: creatinine \\[Cr\\]\\>1.5 times the upper limit of normal \\[ULN\\])\n* Elderly patients with physical weakness or patients complicated with infection\n* Patients with a history of mental illness or dementia\n* Patients with other severe organ or systemic diseases, accompanied by malignant tumors in any organ or system, or undergoing anti-tumor treatment, with an expected survival time of \\\u003C 6 months\n* A significant history of drug or alcohol abuse\n* Women who test positive for blood human chorionic gonadotropin (HCG) (i.e., HCG ≥ 5 mIU\u002FmL) during pregnancy screening, plan to become pregnant during the trial, or are breastfeeding\n* Patients who are currently participating in other clinical trials or have participated in other clinical trials within the past 1 month\n* Patients who are currently using other cholinesterase inhibitor drugs or have used other cholinesterase inhibitor drugs within the past 3 months\n* Patients with epilepsy, hyperkinesis, mechanical intestinal obstruction, bronchial asthma, angina pectoris, bradycardia, or glaucoma\n* Patients with contraindications to brain magnetic resonance imaging (MRI) examination, such as patients with implanted cardiac pacemakers, patients with implanted artificial joints or orthopedic plates, patients with claustrophobia, etc","85 Years",{"count":276,"type":22},66,[204,205],"Although mechanical thrombectomy or thrombolytic therapy for large vessels can achieve a revascularization rate (TICI ≥2b) of over 90%, 30-50% of patients still exhibit poor functional outcomes. This phenomenon of \"ineffective reperfusion\" suggests that microcirculatory dysfunction plays a decisive role in post-stroke neural injury. Therefore, it is necessary to combine brain protection strategies with microcirculatory reperfusion therapy to improve the functional prognosis of stroke patients.Increasing cerebral blood flow (CBF) and neurovascular unit (NVU)-based cerebral protection are current hotspots in the emergency treatment of stroke.\n\nGalantamine, extracted from Lycoris aurea (a traditional Chinese medicinal herb), is an acetylcholinesterase inhibitor (AChEI) that has been widely recognized for improving cerebral blood flow and modulating inflammatory responses in ischemic stroke (IS).\n\nTherefore, the applicant will conduct an internationally compliant, randomized controlled clinical study with routine treatment to evaluate the efficacy of galantamine in the treatment of acute cerebral infarction. This project will conduct a comprehensive assessment of the drug's efficacy from multiple aspects, including improvements in stroke-related outcomes, Traditional Chinese Medicine (TCM) syndrome manifestations, cognitive function, cerebral blood flow, and inflammatory factors.",[87],{"date":281,"type":38},"2025-09-16",{"date":259,"type":22},{"date":284,"type":22},"2028-09-30",{"name":286,"class":69},"Shanghai Yueyang Integrated Medicine Hospital",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":82,"phases":297,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100540714","phase-3-act-global-thrombolysis-act-when-001-domain-within-the-act-global-adaptive-platform-trial-nct06352632-100540714","NCT06320431","ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632","A Multicentre, Prospective, Randomized, Open Label, Blinded-endpoint Trial to Optimize the Use of Intravenous Tenecteplase in Participants With Acute Ischemic Stroke (ACT-GLOBAL THROMBOLYSIS (ACT WHEN-001) Within A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL) NCT06352632","ACT-WHEN","Inclusion Criteria:\n\n1. All patients with disabling AIS presenting within 4.5 hours of symptom onset or last known well who may benefit from intravenous thrombolysis (IVT) with tenecteplase. Patients potentially eligible for IVT with conditions described as relative contraindications in national guidelines where physician discretion is recommended are eligible. Patients who received a DOAC, and those planned for emergency EVT are eligible.\n2. Consent process completed as per national laws and regulation and the applicable ethics committee requirements.\n\nExclusion Criteria:\n\n1. Any absolute contraindication for IV thrombolysis per current national guidelines. Examples include those who are actively bleeding, had recent intracranial surgery, head trauma, intracranial or subarachnoid hemorrhage, or a bleeding diathesis.\n2. Minor stroke patients with non-disabling symptoms.",{"count":296,"type":22},4000,[205],"This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic stroke (AIS) will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment.\n\nThis domain aim is to efficiently, reliably, and simultaneously, determine the comparative effectiveness of intravenous thrombolysis (IVT) using standard-dose intravenous tenecteplase (0.25 mg\u002Fkg body weight), vs. low-dose intravenous tenecteplase (0.18 mg\u002Fkg body weight) in all patients who present to hospital with acute ischemic stroke and are considered for intravenous thrombolysis. In addition, this domain also seeks to study standard-dose intravenous tenecteplase (0.25 mg\u002Fkg body weight), vs. low-dose intravenous tenecteplase (0.18 mg\u002Fkg body weight) vs. no TNK upfront with rescue IA TNK if necessary (in those eligible for emergency EVT) and no TNK upfront in those who have taken DOACs during the preceding 48 hours. This domain therefore seeks to generate more robust randomized evidence to guide clinicians in their decisions over the balance of risks and treatment with intravenous thrombolysis with tenecteplase wherever such evidence is currently insufficient.\n\nThis domain will currently evaluate four research questions in relation to the use of IVT with tenecteplase:\n\n1. In patients with recent (48 hours) intake of a standard-dose direct oral anticoagulant (DOAC), how should IVT be used? - Use standard-dose (0.25 mg\u002Fkg body weight) or low-dose tenecteplase (0.18 mg\u002Fkg) or not at all.\n2. In patients planned to be treated with endovascular thrombectomy, how should tenecteplase be used? -Treat with IV tenecteplase (standard- or low-dose) or not at all.\n3. In any patient receiving IVT, what is the optimal dose of tenecteplase? - use standard-dose (0.25 mg\u002Fkg body weight) or low-dose tenecteplase (0.18 mg\u002Fkg).\n4. To what extent is the treatment effect of standard- vs. low-dose tenecteplase modified by key patient characteristics, such as diabetes, prior antiplatelet therapy, renal failure, or frailty, old age or having a heavy burden of cerebral small vessel disease on brain imaging.",[87,120,300],"Stroke, Acute, Stroke Ischemic",[302,303,304,305,306,307,308],"Stroke","Thrombolysis","Platform","Tenecteplase","Endovascular thrombectomy","EVT","Domain","2025-09-11",{"date":261,"type":38},{"date":312,"type":38},"2024-09-26",{"date":314,"type":22},"2030-12-31",{"name":316,"class":69},"University of Calgary",24,{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":274,"enrollmentInfo":326,"targetDuration":4,"studyType":82,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":165},"100520161","pulse-endovascular-reperfusion-for-acute-ischemic-stroke-100520161","NCT06052969","Pulse Endovascular ReperFUSION for Acute Ischemic Stroke","PERFUSION AIS - Pulse Endovascular ReperFUSION for Acute Ischemic Stroke: An Early Feasibility Clinical Study","PERFUSION AIS","Inclusion Criteria:\n\n1. The participant provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) or an acceptable patient surrogate.\n2. The participant is ≥ 18 years old and less than 85 years old.\n3. Patients with symptomatic large vessel occlusion (LVO) who undergo MT as part of their standard of care and have residual occlusion involving the anterior, middle or posterior cerebral arteries resulting in a eTICI score greater than 2b50 at the end of the procedure with three or less MT device passes.\n4. Estimated delay to onset of rescue Pulse NanoMED MicroBead administration \\\u003C9 hours from symptom onset, defined as the point in time the patient was last known well (LKW).\n5. Post-MT and has had thrombolytic therapy \\\u003C9 hours prior to the proposed start time of System therapy\n6. No significant pre-stroke functional disability (modified Rankin scale 0-1)\n7. Baseline NIHSS≥6\n8. ASPECTS \\>6 on non-contrast CT (NCCT) scan if symptoms lasting \\\u003C8 hours\n9. CT-Perfusion (CTP) is optional, if performed, should demonstrate rCBF \\\u003C30% lesion volume ≤70 mL.\n10. Imaging should be obtained within 75 minutes of the onset of mechanical thrombectomy.\n\nExclusion Criteria:\n\n1. NIHSS score on admission \\>25\n2. Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy\n3. Female who is pregnant or lactating or has a positive pregnancy test at the time of admission\n4. Current participation in another investigational drug or device treatment study\n5. Known allergy or sensitivity to iron\n6. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency\n7. Known coagulopathy, INR \\>1.7, or use of novel anticoagulants \\\u003C12h from symptom onset\n8. Known Platelets \\\u003C100,000\n9. Known Renal Failure as defined by a serum creatinine \\>3.0 mg\u002Fdl (or 265.2 μmol\u002Fl) or glomerular Filtration Rate \\[GFR\\] \\\u003C30\n10. Subject who requires hemodialysis or peritoneal dialysis or who has a contraindication to angiogram for whatever reason\n11. Any hemorrhage on CT\u002FMRI\n12. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.\n13. Suspicion of aortic dissection\n14. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol.\n15. History of life-threatening allergy (more than rash) to contrast medium\n16. SBP \\>185mmHg or DBP \\>110mmHg refractory to treatment\n17. Serious, advanced, terminal illness with anticipated life expectancy \\\u003C6 months\n18. Pre-existing neurological or psychiatric disease that would confound evaluation\n19. Presumed vasculitis or septic embolization\n20. Known sensitivity or allergy to contrast materials that cannot be previously treated properly\n21. The subject takes Coumadin and its interruption could compromise their safety\n22. Known allergy or contraindication to double antiplatelet treatment\n23. Known hypersensitivity or contraindication to iron or polyethylene glycol-based agents\n24. Known contraindication to MRI (examples include, but are not known, implantable cardioverter-defibrillator, pacemaker, clip-on or spiral aneurysm, neurostimulator)\n25. The physical geometry of the subject that prevents the placement of the magnet\n26. The subject has signs or symptoms of systemic infection\u002Fsepsis (temperature of ≥38.0 Celsius and\u002For white blood cell count of ≥12,000 cells\u002FuL). If the subject has a localized infection, such as cellulitis or osteomyelitis, or the infection is properly treated and controlled, according to the discretion of the researcher, the patient can enroll\n27. Known or suspected cardiovascular condition that causes a secondary or tertiary heart block, tachycardia-bradycardia syndrome, or symptomatic postural hypotension requiring medical intervention\n28. Known or suspected symptomatic hemochromatosis or hemosiderosis\n29. Known or suspected liver disease, such as hepatitis and\u002For cirrhosis\n30. The subject has received iron replacement therapy or contrast for iron-based MRI in the previous 30 days",{"count":327,"type":22},8,[117],"Prospective, multi-center, single-arm early feasibility study enrolling a minimum of 15 subjects at up to a minimum of 3 active investigational sites in the United States.\n\nThe subjects must be diagnosed with acute ischemic stroke (AIS), must be post-mechanical thrombectomy, will have had intravenous thrombolytics, and have a visible MCA, ACA or PCA occlusive clot on initial angiographic imaging.\n\nEach subject will receive the Pulse NanoMED procedure after attempted neurovascular therapy to achieve better reperfusion.",[87,331],"Cerebral Arterial Disease",[333,334],"MicroBeads","Pulse NanoMed System","2025-08-04",{"date":337,"type":38},"2025-08-07",{"date":339,"type":38},"2023-10-01",{"date":341,"type":22},"2026-03-15",{"name":343,"class":45},"Euphrates Vascular, Inc.",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":17,"minAge":352,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":82,"phases":355,"briefSummary":357,"conditions":358,"keywords":359,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":368,"leadSponsor":370,"locationsCount":372},"100592607","phase-1-the-stem-cell-derived-extracellular-vesicle-therapy-in-acute-ischemic-stroke-stevia-100592607","NCT06995625","The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)","An Open-Label, Single-Arm, Dose Escalation Phase I Clinical Trial to Evaluate the Safety and Tolerability of SNE-101 in Patients With Acute Ischemic Stroke","STEVIA","Inclusion Criteria:\n\n* Adults with 19 years or older\n* Patients within 5 days of symptom onset who have not received thrombolytic therapy or undergone endovascular reperfusion procedures.\n* Patients within 5 days of symptom onset who have received thrombolytic therapy or undergone endovascular reperfusion procedures but show no clinical recovery after 2 days of observation.\n* Imaging findings must meet both of the following:\n\n  * Infarction within the middle cerebral artery territory on diffusion-weighted imaging (DWI)\n  * Infarct size ≥ 20 mm in the longest diameter on DWI\n* Neurological status meeting all three of the following NIHSS criteria:\n\n  * Moderate to severe neurological deficit (NIHSS score between 5-21)\n  * New onset of motor weakness (score 2-4 in at least one of NIHSS items 5a, 5b, 6a, or 6b)\n  * No impaired consciousness (score 0-1 on NIHSS items 1a, 1b, and 1c)\n* Voluntary written informed consent\n\nExclusion Criteria:\n\nSubjects are ineligible if they meet any of the following:\n\n* Pre-stroke disability (pre-stroke mRS ≥ 2)\n* Likely to recover spontaneously, based on all three of:\n\n  * No longer meeting the NIHSS inclusion criteria 48 hours post-thrombolysis or endovascular therapy\n  * Lacunar stroke due to small vessel occlusion\n  * SAFE (Shoulder Abduction and Finger Extension) score ≥ 5\n* Presence or risk of malignant middle cerebral artery infarction with brain edema\n* Significant medical history within the past 5 years:\n\n  * Severe heart failure\n  * Severe infectious disease\n  * Severe hepatic failure or renal failure\n  * Newly diagnosed or actively treated cancer\n  * Any systemic disease deemed by investigator to significantly reduce life expectancy\n  * Any condition likely to hinder follow-up during the study\n* Diagnosed severe psychiatric illness:\n\n  * Moderate or greater depression pre-stroke with functional impairment and suicide risk\n  * Pre-stroke dementia interfering with daily living (CDR ≥ 2)\n* Contraindication to MRI (e.g., pacemaker)\n* Pregnant or breastfeeding, or unwilling to use effective contraception method for 90 days after last dose.\n* Participation in another clinical trial within the past 3 months\n* Any other reason determined by the investigator that would prevent participation","19 Years",{"count":354,"type":22},18,[356],"PHASE1","This is a multicenter open-label, single-arm, dose escalation phase I clinical trial to evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke",[87],[302,360,361,362,363],"Exosome","Extracellular vesicles","Wharton's jelly-mesenchymal stem cell","MSC","2025-07-31",{"date":366,"type":38},"2025-08-01",{"date":366,"type":22},{"date":369,"type":22},"2027-03-31",{"name":371,"class":45},"S&Ebio Co. Ltd.",3,{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":82,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":165},"100524925","phase-4-intravenous-thrombolytic-therapy-for-acute-ischemic-stroke-patients-with-low-nihss-and-non-disabling-deficits-100524925","NCT06115070","Intravenous Thrombolytic Therapy for Acute Ischemic Stroke Patients with Low NIHSS and Non-disabling Deficits","ALLOW","Inclusion Criteria:\n\n1. Patients with clinical signs of acute ischemic stroke within 4.5 hours of onset or awakening with stroke (if within 4.5 hours from the midpoint of sleep).\n2. Patinet's age is \\>18 years\n3. Patients with NIHSS ≤ 5, a limb-related NIHSS item score of 0, and with any of the following NIHSS item ≥2: Best Gaze, Visual, Facial palsy, Limb ataxia, Sensory, Best language, Dysarthria, Extinction and Inattention.\n\nExclusion Criteria:\n\n(1) Plan to receive endovascular treatment; (2) Pre-stroke mRS score \\> 2 (3) Contraindications for IVT：\n\n1. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.)\n2. Previous history of intracranial hemorrhage\n3. Severe head trauma or stroke history within the last 3 months\n4. Intracranial tumors, giant intracranial aneurysms\n5. Intracranial or spinal surgery within the recent 3 months\n6. Major surgical procedures within the last 2 weeks\n7. Gastrointestinal or urinary tract bleeding within the last 3 weeks\n8. Active visceral bleeding\n9. Aortic arch dissection\n10. Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding\n11. Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg\n12. Acute bleeding tendency, including platelet count \\\u003C 100 × 10⁹\u002FL or other conditions\n13. Received low-molecular-weight heparin treatment within 24 hours\n14. Oral anticoagulants (warfarin) with INR \\> 1.7 or PT \\> 15 s; Receiving heparin treatment with aPTT above the upper limit of the normal range within the last 24 hours of onset, Receiving thrombin inhibitors and factor Xa inhibitors within the last 48 hours of onset.\n15. Blood sugar \\\u003C 2.8 or \\> 22.22 mmol\u002FL\n16. Head CT or MRI indicates large-area infarction (infarction area ≥ 1\u002F3 of the middle cerebral artery supply area) (4) The judgment is left to the discretion of the investigator",{"count":115,"type":22},[84],"Minor stroke is considered an acute ischemic stroke (AIS) that has a National Institute of Health Stroke Scale (NIHSS) score ≤ 5 points. About 1\u002F3 patients with mild stroke have poor prognosis, whether patients with this type undergo thrombolysis has been a controversial issue. A pooled analysis published in the Lancet in 2014 included 9 high-quality RCT studies of intravenous thrombolysis such as NINDS and IST3, and a total of 666 (10%) patients with mild stroke were included in the analysis. For mild stroke, the proportion of good prognosis in the control group and the alteplase group was 58.9% and 68.7% (OR 1.48, 95%Cl 1.07-2.06), respectively. Therefore, guidelines recommended alteplase thrombolytic therapy for patients with mild stroke. However, PRISMS, a randomized controlled trial of intravenous thrombolytic therapy for mild stroke published in 2018, found that alteplase intravenous thrombolytic therapy did not improve clinical outcomes compared with aspirin in patients with mild non-disabled stroke (90-day mRS 0-1 ratio 78.2% vs 81.5%), and the incidence of symptomatic intracranial hemorrhage was higher. However, a major limitation of the PRISMS study was that more than 85% of patients had numbness and dysarticulation, so this conclusion cannot be extrapolated to patients with other mild stroke symptoms. Moreover, due to the early termination of the sponsorship of this trial, the number of enrolled cases did not reach the pre-designed number, resulting in a serious decline in the authenticity of the study results. Symptoms and outcomes of minor stroke are important criteria for assessment. However, there is currently no uniform standard for the assessment of disability.\n\nBoth international and domestic guidelines recommend IVT with alteplase for minor disabling stroke within 4.5h, but not routinely recommend intravenous thrombolysis for minor nondisabling stroke within 4.5h. It is important to underline that strokes with low NIHSS scores are not necessarily nondisabling. Despite, patients with mild stroke symptoms are often excluded from IVT due to safety concerns potentially outweighing the putative benefits of recanalization therapy.\n\nTherefore, the investigators developed a new definition to refine the disability assessment of stroke symptoms. The purpose of this study was to investigate whether AIS patients with NIHSS ≤ 5, a limb-related NIHSS item score of 0, and with any of the following NIHSS item ≥2: Best Gaze, Visual, Facial palsy, Limb ataxia, Sensory, Best language, Dysarthria, Extinction and Inattention, could benefit from intravenous thrombolysis.",[384,26],"Thrombosis","2025-03-05",{"date":387,"type":38},"2025-03-06",{"date":389,"type":22},"2025-03-01",{"date":391,"type":22},"2028-12-31",{"name":393,"class":69},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":17,"minAge":401,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":82,"phases":403,"briefSummary":404,"conditions":405,"keywords":406,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":165},"100575853","palmitoylethanolamide-and-luteolin-in-patients-with-acute-ischemic-stroke-100575853","NCT06777680","Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke","Efficacy of Palmitoylethanolamide and Luteolin on Early Functional Recovery in Acute Stroke Patients Treated with Thrombectomy: a Pilot Randomized Placebo-controlled Prospective Study","Inclusion Criteria:\n\n* age ≥ 60 years\n* both genders\n* first acute ischemic stroke in the middle cerebral artery area confirmed by angio-CT and CTP, eligible for mechanical thrombectomy according to national guidelines\n* NIHSS \\> 6\n* compliant patients\n* signed informed consent\n\nExclusion Criteria:\n\n* hemorrhagic stroke\n* previous stroke (TIA, ischemic or hemorrhagic stroke)\n* presence of clinically evident neurodegenerative diseases (Alzheimer's disease, Parkinson's disease)\n* presence of psychiatric comorbidity (schizophrenia, bipolar disorder, depressive syndrome)\n* presence of chronic inflammatory diseases (chronic inflammatory bowel disease, vasculitis etc.)\n* current or previous neoplasia\n* uncontrolled diabetes mellitus (glycemia on admission \\>400 mg\u002FdL or \\\u003C50 mg\u002FdL)\n* dysphagia, with inability to feed orally\n* inability to provide informed consent\n* pre-existing disability (pre-stroke mRS \\>2)\n* allergy or hypersensitivity to the study treatment","60 Years",{"count":56,"type":22},[117],"Acute ischemic stroke is caused by reduced blood supply to the brain associated with neuroinflammation. This mechanism contributes to acute neuronal death and persists even after reopening of the closed vessel, with consequent limitation of clinical and functional improvement.\n\nExperimental and clinical evidence demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultramicronized Palmitoylethanolamide (PEA).\n\nThe aim of this study is to evaluate the effect of co-ultramicronized PEA and luteolin (700 mg + 70 mg in 10 ml) on the clinical outcomes of patients with acute ischemic stroke undergoing mechanical thrombectomy.",[87],[302,407,408,409],"Neuroinflammation","Palmitoylethanolamide","Luteolin","2025-01-10",{"date":412,"type":38},"2025-01-16",{"date":414,"type":22},"2025-01",{"date":416,"type":22},"2026-12",{"name":418,"class":69},"Ospedali Riuniti Trieste",{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":427,"sex":17,"minAge":18,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":82,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":165},"100568344","phase-1-a-phase-i-clinical-trial-evaluating-the-safety-tolerability-and-pharmacokinetics-of-aapb-for-injection-100568344","NCT06679998","A Phase I Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of AAPB for Injection","A Dose-increasing, Randomized, Double-blind, Placebo-controlled, Single-dose\u002Fmultiple-dose Phase I Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of AAPB for Injection in Healthy Chinese Subjects.","AAPB","Inclusion Criteria:\n\n1. Healthy subjects, aged between 18 and 45 (both ends included), both male and female;\n2. When screening patients, male weight ≥50kg, female weight ≥45kg, body mass index (BMI) in the range of 19-28 kg\u002Fm\\^2 (including the upper and lower limits), BMI= weight (kg)\u002Fheight (m) \\^2;\n3. Able to communicate well with researchers, willing and able to comply with the lifestyle restrictions specified in the program;\n4. Women or men of reproductive age who agree to use investigatorial-approved contraceptive methods (such as Iuds, condoms, spermicide gel plus condoms, diaphragms, etc.) throughout the trial period;\n5. Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent, and be able to complete the whole process of the trial according to the requirements of the trial.\n\nExclusion Criteria:\n\n1. The investigator determines that the subject has a history of present disease and past disease or dysfunction affecting the clinical trial, including but not limited to diseases of the nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, metabolic disease, rheumatic disease, blood system, etc.;\n2. Suffers from mental illness or has a history of mental illness;\n3. Have a history of malignant tumors or other diseases that are not suitable for clinical trials;\n4. History of cardiovascular disease (such as heart dysfunction, coronary artery disease, cardiomyopathy, valvular heart disease, family history of congenital long QT syndrome, family history of sudden death, etc.) or ECG results showing QTcF \\> 450ms, or clinically significant conduction block or T wave changes;\n5. Abnormal liver function (ALT, AST higher than the upper limit of normal reference value);\n6. Any drugs that inhibit or induce liver drug metabolism enzymes (such as: inducers barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.) were used within 30 days before drug administration; Inhibitors 5-hydroxyserotonin reuptake inhibitor (SSRI) antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines, etc. Or any prescription, over-the-counter, and herbal medicines other than those described above have been taken in the 14 days prior to drug administration;\n7. Participated in any clinical trials within 3 months before enrollment;\n8. Those who have special requirements for food and cannot comply with a unified diet;\n9. People who consumed any caffeine-rich food or drink (coffee, tea, cola, chocolate, etc.) within 48 hours before the study drug administration, or who do not agree to prohibit the use of any caffeine-rich food or drink during the study period;\n10. Known allergic history of test drug ingredients or similar drugs, allergic disease history or allergic constitution;\n11. Smokers who smoked more than 10 cigarettes or equivalent cigarettes per day in the 1 year prior to screening, or those who could not comply with the prohibition of smoking during the test period;\n12. Alcohol-addicted persons with an average weekly alcohol intake of more than 14 units (1 unit =285ml beer or 25ml spirits or 150ml wine) or positive for alcohol breath test in the year before screening;\n13. Persons with a history of drug or drug abuse within the year prior to screening, or who test positive for drug abuse (screening items include: morphine, THC, methamphetamine, dimethylene dioxyamphetamine, ketamine and cocaine);\n14. Complete physical examination, vital signs, laboratory examination, ECG examination determined by the investigator to be abnormal and clinically significant;\n15. Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-AB), Treponema pallidum antibody (TP-Ab) any of the positive results;\n16. Women who are pregnant or nursing, or who test positive for serum HCG before trial administration, or who are unable or unwilling to use investigator-approved contraception during the study period and for 3 months after the end of the study as directed by the investigator;\n17. Study blood donation or blood loss ≥200ml within 3 months before drug administration, or have a history of blood product use;\n18. Patients with a history of surgery within 3 months prior to study administration, or who have not recovered from surgery, or who have an anticipated surgical plan during the trial period;\n19. Persons directly related to the clinical trial;\n20. Patients who cannot tolerate venipunction and have a history of fainting needles and fainting blood;\n21. Other subjects deemed unsuitable for this study by the investigator.",true,"45 Years",{"count":430,"type":22},56,[356],"This is a Phase I clinical to evaluate the safety and tolerability of single and multiple intravenous infusions of AAPB at different doses over 7 consecutive days.",[26],"2024-11-06",{"date":436,"type":38},"2024-11-08",{"date":438,"type":22},"2024-11-14",{"date":440,"type":22},"2026-03-26",{"name":442,"class":45},"Jiangsu Kanion Pharmaceutical Co., Ltd"]