[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intracranial-arteriosclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intracranial-arteriosclerosis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,70,101,126],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100638257","phase-4-efficacy-and-safety-study-of-digital-cognitive-training-and-pcsk9-inhibitor-enhanced-lipid-lowering-strategy-in-patients-with-intracranial-atherosclerotic-stenosis-a-22-randomized-controlled-trial-100638257",false,"NCT07605130","Efficacy and Safety Study of Digital Cognitive Training and PCSK9 Inhibitor-Enhanced Lipid-lowering Strategy in Patients With Intracranial Atherosclerotic Stenosis: A 2×2 Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 55-80 years old\n2. The number of years of education is greater than or equal to 6 years\n3. 50%-99% stenosis of the intracranial artery confirmed by MRA, CTA or DSA\n4. Head CT or MRI confirmed that there were no infarct lesions\u002Fsoftening foci larger than 3 cm in the brain\n5. LDL-C ≥ 1.8mmol\u002FL at baseline\n6. Decline in cognitive function of the complainant\n7. MMSE ≥ 24 points; no severe impairment of daily living and social functioning, and the daily living ability scale (ADL, 14-item BADL and IADL combined version, total score range of 14-56 points) \\\u003C=18; and the investigator's clinical assessment does not meet the diagnosis of dementia (DSM-V or NIA-AA diagnostic criteria)\n8. Proficient in operating electronic products such as mobile phones and tablets\n9. Complete the operation evaluation through the introduction period (see the definition of the introduction period)\n10. Agree to receive maximally tolerated statin and PCSK9 inhibitor therapy during the study period\n11. Able to cooperate with neuropsychological and multimodal magnetic resonance examinations\n\nExclusion Criteria:\n\n1. Extracranial vascular stenosis ≥ 50%\n2. Acute cerebrovascular events within 90 days\n3. Contraindications to MRI (metal implants in the body, claustrophobia, etc.)\n4. Visual and auditory impairments, as well as communication difficulties, that affect cognitive training\n5. Clinically diagnosed vascular dementia\n6. Neuroimaging showing significant white matter lesions (Fazekas grade 3) or multiple microbleeds\n7. Non-atherosclerotic intracranial artery stenosis (such as vasculitis, moyamoya disease, dissection, etc.)\n8. Neurodegenerative diseases (Alzheimer's disease, Parkinson's disease, etc.)\n9. Severe comorbidities (tumors, multiple sclerosis, severe cardiopulmonary and renal diseases, intracranial aneurysms)\n10. Other diseases that may affect cognition have been ruled out; severe anxiety, depression, or schizophrenia; a new stroke occurring within the 3 months prior to baseline; hereditary or inflammatory small vessel diseases; presence of any of the following clear sources of cardioembolic events: mitral stenosis, mechanical heart valves, endocarditis, intracardiac clots or vegetations, dilated cardiomyopathy, chronic or paroxysmal atrial fibrillation, ejection fraction less than 30%\n11. Planning to use medications that may affect cognitive function within the past 3 months or in the following 24 weeks, including large amounts of sedatives, anti-anxiety drugs, cognitive enhancers, and cholinergic agents.(12) Previously treated with a PCSK9 inhibitor\n12. Having a clear contraindication or severe intolerance to PCSK9 inhibitors or statins (such as a history of severe allergic reactions)\n13. Presence of significant liver or muscle safety abnormalities at baseline, or the investigator deems the patient unsuitable for intensive lipid-lowering therapy (for example, significantly elevated ALT or AST, significantly elevated CK, etc.; the thresholds can be based on the reference ranges of each center's laboratory and specified in the protocol in advance)\n14. Other circumstances deemed inappropriate for enrollment by the investigator","ALL","55 Years","80 Years",{"count":19,"type":20},420,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This study aims to evaluate whether digital cognitive training and\u002For intensive lipid-lowering therapy with a PCSK9 inhibitor can improve cognitive function in patients with intracranial atherosclerosis (ICAS).\n\nICAS is a common cause of stroke and is also linked to thinking and memory problems. The study will enroll 420 adults aged 55-80 years who have 50-99% narrowing of an intracranial artery, subjective memory complaints, and LDL cholesterol ≥1.8 mmol\u002FL, but who are not demented.\n\nParticipants will be randomly assigned to one of four groups in a 2×2 factorial design:\n\n1. No cognitive training + standard statin therapy\n2. Cognitive training + standard statin therapy\n3. No cognitive training + intensive statin plus PCSK9 inhibitor\n4. Cognitive training + intensive statin plus PCSK9 inhibitor\n\nCognitive training consists of 30 minutes of tablet-based exercises, 5 days per week for 12 weeks. The intensive lipid-lowering group receives a PCSK9 inhibitor (Recaticimab) injection at weeks 0, 4, and 12, on top of maximally tolerated statin.\n\nThe main outcome is change in a composite cognitive score from baseline to 24 weeks. Secondary outcomes include changes in specific cognitive domains, MRI markers of brain structure and function, and safety measures.\n\nThe study is multicenter, open-label with blinded outcome assessment, and is conducted under the approval of the ethics committee of Peking Union Medical College Hospital.",[26,27],"Intracranial Arteriosclerosis","Cognitive Impairment",[29,30,31,32],"Cognitive Dysfunction","Cognitive Training","Artificial Intelligence","Computerised Cognitive Training","NOT_YET_RECRUITING","2026-05-17",{"date":36,"type":37},"2026-05-22","ACTUAL",{"date":39,"type":20},"2026-05-25",{"date":41,"type":20},"2029-07-31",{"name":43,"class":44},"Peking Union Medical College Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":17,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100587252","phase-3-a-randomized-trial-of-the-rapamycin-target-eluting-stent-for-the-treatment-of-symptomatic-cerebral-artery-atherosclerotic-diseasetarget-dream-100587252","NCT06925971","A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）","A Prospective, Multi-center, Open-label, Controlled, Superiority, Randomized, Controlled Registration Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）","Inclusion Criteria:\n\n* 1\\) Age 18-80 years old\n* 2\\) Symptomatic cerebral artery atherosclerotic stenosis (defined as ischemic stroke or TIA due to qualifying lesion stenosis occurring in the past 6 months) with ineffective antiplatelet therapy or hypoperfusion in the territory of qualifying artery or with poor collateral circulation\n* 3\\) Lesion located in a major cerebral artery, including the internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery\n* 4\\) 70%-99% stenosis of qualifying lesion according to WASID method diagnosed by DSA\n* 5\\) Subject with at least one or more risk factors, including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary artery disease, obesity, smoking history, etc\n* 6\\) Subject and\u002For their legal representatives have the necessary mental capacity to understand the study purpose, agree to participate in the study, and sign the informed consent form\n\nExclusion Criteria:\n\n* 1\\) mRS score≥3\n* 2\\) Last ischemic stroke onset within 2 weeks\n* 3\\) Presence of 2 or more atherosclerotic stenotic lesions in the cerebral arteries requiring interventional or surgical treatment.\n* 4\\) Only perforator infarctions in the territory of qualifying artery according to preoperative imaging\n* 5\\) Hemorrhagic transformation in the territory of qualifying artery. Any parenchymal, subarachnoid, subdural, or extradural hemorrhage within 30 days prior to procedure, or untreated chronic subdural hematoma(≥5 mm) according to preoperative imaging\n* 6\\) Restenosis of qualifying lesion due to previous stenting.\n* 7\\) Qualifying lesion with severe calcification, extreme eccentricity, or extreme angulation which may affect stent deployment\n* 8\\) Stenosis caused by non-atherosclerotic lesions, such as arterial dissection, moya-moya disease, or vasculitis\n* 9\\) Concomitant severe stenosis (≥70% stenosis as measured by the WASID method) in the distal or proximal to qualifying lesion\n* 10\\) Concomitant multiple stenoses where qualifying lesions cannot be identified\n* 11\\) Thrombus in the qualifying artery or complete occlusion of the qualifying artery\n* 12\\) Severe calcification or tortuosity of qualifying artery to prevent stent from successful positioning and dilatation\n* 13\\) Stenting in qualifying artery within one year\n* 14\\) Concomitant aneurysms requiring treatment\n* 15\\) Concomitant intracranial malignant tumors, intracranial arteriovenous malformations, intracranial venous sinus thrombosis, or other conditions inappropriate to participate in the study\n* 16\\) Resistant hypertension (systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg) despite use of medication\n* 17\\) Acute myocardial infarction within 4 weeks prior to enrollment, or suspected cardiogenic embolism\n* 18\\) Subjects with severe systemic diseases that cannot tolerate surgery, such as severe hepatic or renal impairment\n* 19\\) Severe cognitive impairment or mental diseases\n* 20\\) Contraindications to anticoagulants or antiplatelet drugs, such as anticoagulant or antiplatelet drug allergy, active bleeding, or coagulation disorder\n* 21\\) Subjects with allergy or suspected allergy to anesthetics, contrast agents, rapamycin, polylactic acid, nickel-titanium alloy, cobalt-chromium alloy, stainless steel, and other stent materials, medications, and intraoperative medications\n* 22\\) Women who are pregnant or breastfeeding\n* 23\\) Subjects who are participating or planning to participate in any drug or device clinical study at the time of enrollment\n* 24\\) Life expectancy ≤ 1 year\n* 25\\) Other conditions inapplicable to participate in the study according to investigators' judgment","18 Years",{"count":55,"type":20},279,[57],"PHASE3","The trial is a prospective, multicenter, open-label, superiority, randomized controlled clinical trial. The experimental groups include two types of drug-eluting stents:\n\n* Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)\n* Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) The device used in the control group is the Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China), According to the inclusion and exclusion criteria specified in the protocol, approximately 249 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group A, Experimental Group B, or the control group.\n\nConsidering the broader applicability of Experimental Device A and Experimental Device B compared to the control device, a specification subgroup is established. 20 subjects with lesions only suitable for the unique specifications of Experimental Device A or Experimental Device B will be enrolled in China. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing.\n\nMoreover, a subgroup of Experimental Device B is established at a study center in Brazil. 10 subjects meeting the trial's inclusion and criteria will be enrolled. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing, only to support overseas registration.\n\nOverall, the total sample size for the study is 279 subjects. Clinical assessment will be conducted for all subjects before the procedure, during the procedure, at discharge, at 1 month (±7 days) follow-up, at 6 months (±30 days) follow-up, and at 12 months (±60 days) follow-up. At 12 months (±60 days), patients will undergo follow-up with DSA imaging. Unscheduled follow-ups may be performed as needed to record relevant indicators and evaluate the safety and efficacy of the two drug-eluting stents in the treatment of symptomatic cerebral artery atherosclerotic stenosis.",[26],"2025-04-11",{"date":62,"type":37},"2025-04-13",{"date":64,"type":20},"2025-04-15",{"date":66,"type":20},"2027-10-01",{"name":68,"class":69},"MicroPort NeuroTech Co., Ltd.","INDUSTRY",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":5},"100492495","a-registry-study-of-intracranial-atherosclerotic-stenosis-treatment-by-intracranial-drug-eluting-stenting-in-china-100492495","NCT05692882","A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China","To Evaluate the Safety and Efficacy of the NOVA Intracranial Drug-eluting Stent System in \"real World\" Patients with Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Post-marketing Registry Clinical Study (NOVA II)","Inclusion Criteria:\n\n1. Males or females between 18 and 80 years of age;\n2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;\n3. intracranial artery stenosis ( ≥70%) conformed by digital subtraction angiography (DSA);\n4. Those who voluntarily participate in the study and sign informed consent form.\n\nExclusion Criteria:\n\n1. Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);\n2. Subjects of acute hemorrhagic stroke within 3 months;\n3. The baseline mRS of disabling stroke is more than 3;\n4. The target vessel is severely calcified and closely related to stenosis;\n5. Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);\n6. It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);\n7. Target artery's supplying artery stenosis \\> 50%. For example, patient with middle cerebral artery (MCA) severe stenosis (target artery) and the ipsilateral internal carotid artery (ICA) stenosis \\> 50% should be excluded; patient with basilar artery (BA) severe stenosis (target artery) and the dominant vertical artery (VA) stenosis \\> 50% should be excluded;\n8. There are intracranial tumors, or intracranial arteriovenous malformations;\n9. Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components;\n10. Pregnant and lactating women\n11. Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;\n12. Inapplicable for this study at the investigators' viewpoints.","85 Years",{"count":79,"type":20},1000,[81],"NA","The primary objective of this trial is to evaluate the long-term safety and efficacy of the NOVA intracranial drug-eluting stent system in \"real world\" patients with intracranial atherosclerotic stenosis.",[26,84,85,86],"Stenosis Artery","Drug-Eluting Stents","Intracranial Artery Stenosis",[88,89,90],"endovascular therapy","intracranial drug-eluting stent","symptomatic intracranial artery stenosis (sICAS)","RECRUITING","2025-03-26",{"date":94,"type":37},"2025-04-01",{"date":96,"type":37},"2023-11-16",{"date":98,"type":20},"2029-12-30",{"name":100,"class":69},"Sino Medical Sciences Technology Inc.",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":17,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":45},"100534769","phase-4-pair-antiplatelet-therapy-in-ischemic-stroke-with-intracranial-artery-stenosis-100534769","NCT06243133","Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis","PATH-ICAS","Inclusion Criteria:\n\n1. Age 40 \\~ 80 years old;\n2. Patients diagnosed as non-cardiogenic cerebral infarction according to the WHO definition of stroke, with MRA\u002FCTA\u002FDSA confirmed intracranial artery stenosis ≥50% (intracranial carotid artery, M1 and proximal M2 segment of middle cerebral artery, A1 and A2 segment of anterior cerebral artery, P1 and P2 segment of posterior cerebral artery, intracranial vertebral artery and basilar artery);\n3. First stroke onset within 7 days;\n4. NIHSS score ≤5;\n5. Patients or family members sign informed consent forms;\n\nExclusion Criteria:\n\n1. Patients receiving thrombolysis or endovascular therapy;\n2. Patients with recurrent stroke;\n3. Patients has undergone major surgery or major trauma within the past 30 days;\n4. History of gastrointestinal bleeding, active peptic ulcer, intracranial hemorrhage or other hemorrhagic diseases;\n5. Contraindications or intolerances to the use of antiplatelet therapeutics;\n6. Platelet count \\\u003C100\\*109\u002FL, hemoglobin\\\u003C110g\u002FL;\n7. Patients with severe organ insufficiency or other serious disease (e.g., severe cardiopulmonary failure, advanced tumor, severe dementia);\n8. Patients intolerant to MRI scan are replaced by CT or DSA;\n9. poor compliance, unable to meet the requirements of the study.","40 Years",{"count":110,"type":20},1100,[23],"The goal of this clinical trial is to learn about efficacy and safety of dual antiplatelet therapy in ischemic stroke with intracranial artery stenosis. The main question it aims to answer are:\n\nwhether aspirin combined with clopidogrel for 3 month is better than 1 months for patients with non-cardiogenic cerebral infarction with intracranial artery stenosis.\n\nParticipants will get dual antiplatelet therapy (aspirin plus clopidogrel) for 1 month or 3 months within 7 days of the first stroke.\n\nResearchers will compare experimental group (3 months dual antiplatelet therapy) with comparison group (1 month dual antiplatelet therapy), to see if experimental group would reduce stroke recurrence or mortality, and increase bleeding and other adverse prognosis.",[114,26,115,116],"Ischemic Stroke","Secondary Prevention","Antiplatelet Drug","2024-06-17",{"date":119,"type":37},"2024-06-18",{"date":121,"type":20},"2024-07-01",{"date":123,"type":20},"2026-03-31",{"name":125,"class":44},"Sichuan Provincial People's Hospital",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":133,"targetDuration":135,"studyType":136,"phases":4,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":45},"100489468","remote-ischemic-conditioning-combined-with-endovascular-stenting-for-symptomatic-intracranial-atherosclerotic-stenosis-100489468","NCT05653505","Remote Ischemic Conditioning Combined With Endovascular Stenting for Symptomatic Intracranial Atherosclerotic Stenosis","Safety and Efficacy of Remote Ischemic Conditioning Combined With Endovascular Stenting in Patients With Symptomatic Intracranial Atherosclerotic Stenosis","Inclusion Criteria:\n\n1. Patient admitted from Jan. 1st 2023 to Jan. 1st 2025;\n2. Age ≥ 18;\n3. Intracranial atherosclerosis stenosis measured as ≥70% by digital subtraction angiography or by other noninvasive methods, such as transcranial doppler, computed tomography angiography, or magnetic resonance angiography;\n4. A history of stroke\u002Ftransient ischemic attack attributed to ICAS;\n5. Verbal and written informed consent is provided at the time of admission by patients or their legally authorized representatives.\n\nExclusion Criteria:\n\n1. Stenosis of other causes;\n2. Prior ipsilateral stroke with residual deficits;\n3. Uncontrolled hypertension (defined as systolic blood pressure ≥200 mm Hg despite medications at enrollment);\n4. Peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion).",{"count":134,"type":20},160,"12 Months","OBSERVATIONAL","The purpose of this registry is to evaluate the safety and efficacy of RIC for patients with symptomatic intracranial atherosclerotic stenosis (sICAS) undergoing endovascular therapy.",[26,139,140],"Ischemic Preconditioning","Endovascular Procedures",[142,143,144],"Remote Ischemic Conditioning","Endovascular Stenting","Symptomatic Intracranial Atherosclerotic Stenosis","2022-12-15",{"date":147,"type":37},"2022-12-16",{"date":149,"type":20},"2023-01-01",{"date":151,"type":20},"2026-07-01",{"name":153,"class":44},"Tianjin Huanhu Hospital"]