[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"symptomatic-intracranial-atherosclerotic-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:symptomatic-intracranial-atherosclerotic-stenosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,73,100],{"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":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100656753","drug-coated-balloon-for-endovascular-treatment-versus-aggressive-medical-management-in-high-risk-symptomatic-intracranial-atherosclerotic-stenosis-100656753",false,"NCT07830277","Drug-Coated Balloon vs Aggressive Medical Management for High-Risk Symptomatic Intracranial Atherosclerotic Stenosis","Drug-coated Balloon for Endovascular Treatment Versus Aggressive Medical Management in High-Risk Symptomatic Intracranial Atherosclerotic Stenosis","DRBEYOND2","Inclusion Criteria:\n\n1. Age 18-80 years old, regardless of gender\n2. Patients with symptomatic ICAS caused by stenosis of a major intracranial artery (the degree of ischemic stroke with target vessel stenosis within 90 days before enrollment is required to be 70-99%, or the degree of transient ischemic attack with target vessel stenosis is required to be 80-99%), standardized drug management of at least one antithrombotic drug and\u002For vascular risk factors\n3. DSA or CTA confirmed that the stenosis degree of one main intracranial artery (internal carotid artery C4-C7 segment, middle cerebral artery M1 segment, vertebral artery V4 segment and basilar artery) was between 70% and 99% (measured by WASID method), and was corresponding to the clinical symptoms. The normal diameter of the proximal end of the target lesion was ≥ 2mm, and the length of the target lesion was ≤ 15mm\n4. If the target lesion is located in the anterior circulation system (C4-C7 of the internal carotid artery or M1 of the middle cerebral artery), it is required that there is hypoperfusion in the blood supply area of the target vessel (at least one of the following conditions is met): ①head CTP or PWI showed that CBF in the target vessel area decreased significantly (the lesion side decreased by more than 30% compared with the opposite side); ②Cerebral infarction with hemodynamic abnormalities confirmed by head CT or MRI (such as watershed infarction); ③ASITN\u002FSIR collateral circulation score based on DSA\\\u003C3 points)\n5. Those who voluntarily participated in the study and signed the informed consent\n\nExclusion Criteria:\n\n1. Serious calcification of target vessels, or serious distortion of target vessels or anatomical factors make it difficult for interventional instruments to be in place\n2. Severe stenosis or occlusion of extracranial or intracranial vessels in series at the proximal or distal end of the target vessel\n3. Major surgical operations have been performed in recent 3 weeks\n4. Cerebral hemorrhage, massive cerebral infarction (the infarct area is greater than 50% of the middle cerebral artery supply area; cerebellar infarction: the infarct diameter is greater than 3cm) and myocardial infarction have occurred in the past three months\n5. The target lesion has undergone stent implantation before\n6. Intracranial artery stenosis caused by non atherosclerotic lesions, including but not limited to: arterial dissection, moyamoya disease, vasculitis, radiation vascular disease or fibromuscular dysplasia\n7. mRS score ≥ 3\n8. Patients with coagulation dysfunction\n9. Those who cannot tolerate anesthesia and anticoagulant drugs, are contraindicated or allergic to surgical drugs (paclitaxel, heparin, contrast agent, aspirin, clopidogrel, etc.), and are allergic to surgical instruments or operating devices\n10. Platelet (PLT\\\u003C90×109\u002FL),hematocrit (\\\u003C30%), international normalized ratio (INR)\\>1.5, uncontrollable severe hypertension (systolic blood pressure\\>180mmHg or diastolic blood pressure\\>110mmHg),severe liver injury (ALT or AST more than 3 times the normal value), severe renal function injury (creatinine\\>3mg\u002Fdl,\\>265μmol\u002FL),and severe insufficiency of other important organs such as heart and lung\n11. The subjects participated in other clinical trials and have not completed the follow-up or the researchers judged that the patients' compliance was poor and they were unable to complete the follow-up as required\n12. Pregnant or lactating women, or those who plan to become pregnant within one year\n13. The disease will cause difficulties in treatment and follow-up evaluation (such as dementia or mental disorders, cancer, infection, severe metabolic diseases), and it is speculated that the life expectancy of the participants is less than 3 years\n14. Other cases that clinicians think should be excluded","ALL","18 Years","80 Years",{"count":21,"type":22},570,"ESTIMATED","INTERVENTIONAL",[25],"NA","DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint, parallel-group clinical trial designed to evaluate the efficacy and safety of drug-coated balloon (DCB) angioplasty plus aggressive medical management compared with aggressive medical management alone in patients with high-risk symptomatic intracranial atherosclerotic stenosis (sICAS).\n\nA total of 570 eligible patients will be randomized in a 1:1 ratio to the DCB group or the medical management group. Patients assigned to the DCB group will undergo DCB angioplasty in addition to aggressive medical management, with rescue stenting permitted when clinically necessary according to the study protocol. Patients assigned to the control group will receive aggressive medical management alone.\n\nThe primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Participants will be followed for up to 3 years to further evaluate recurrent ischemic events, vascular outcomes, functional outcomes, and long-term safety.",[28],"Symptomatic Intracranial Atherosclerotic Stenosis",[30,31,32,33,34,35,36],"Intracranial atherosclerotic stenosis","Symptomatic intracranial atherosclerotic stenosis","Drug-coated balloon","Balloon angioplasty","Endovascular treatment","Aggressive medical management","Ischemic stroke","NOT_YET_RECRUITING","2026-09-20",{"date":40,"type":41},"2026-09-23","ACTUAL",{"date":43,"type":22},"2026-10-01",{"date":45,"type":22},"2031-06-01",{"name":47,"class":48},"Beijing Tiantan Hospital","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100634688","medeliver-intracranial-drug-coated-balloon-catheter-for-symptomatic-intracranial-atherosclerotic-stenosis-100634688","NCT07542938","Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis","Safety and Efficacy of Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis(Prospective, Multicenter, Randomized Controlled, Superiority Trial)","Inclusion Criteria:\n\n1. Age 18-80 years;\n2. Symptomatic intracranial arterial stenosis within the past 6 months, with 70%-99% diameter stenosis on angiography (per WASID criteria);\n3. Target lesion located in: intracranial segment of the internal carotid artery (C3 or above), M1\u002FM2 segment of the middle cerebral artery, basilar artery, or intracranial segment of the vertebral artery;\n4. At least one atherosclerotic risk factor (history or current hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, smoking, or alcohol consumption);\n5. Reference vessel diameter adjacent to the target lesion ≥ 2 mm；\n6. Baseline mRS score ≤ 2;\n7. Patient or legally authorized representative understands the study purpose, voluntarily agrees to participate, provides written informed consent, and is willing and able to comply with follow-up visits.\n\nExclusion Criteria:\n\n1. Acute ischemic stroke within 2 weeks prior to screening;\n2. Major surgery or acute myocardial infarction within 30 days prior to screening;\n3. Intracranial hemorrhage (parenchymal, subarachnoid, subdural, or extradural) within 3 months prior to screening;\n4. Uncontrolled hypertension despite medical therapy (systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg);\n5. Coexisting intracranial tumor, intracranial aneurysm requiring treatment, or arteriovenous malformation;\n6. Previous stenting of the target lesion or any intracranial stenting\u002Fendovascular procedure within the past 3 months;\n7. Cardioembolic stroke;\n8. Stroke caused solely by perforator artery occlusion;\n9. Two or more consecutive lesions with ≥ 70% stenosis in the target vessel;\n10. Additional de novo or in-stent restenosis lesions (\\> 70% diameter stenosis);in other intracranial arteries requiring treatment during the same session;\n11. Severe calcification, extreme angulation, severe tortuosity, or other anatomical features in the target vessel that may prevent safe device delivery or retrieval;\n12. Known allergy or contraindication to heparin, sirolimus (rapamycin), iodinated contrast, aspirin, clopidogrel, or local anesthetics;\n13. Gastrointestinal bleeding within 6 months prior to informed consent, rendering antiplatelet therapy unsafe;\n14. Platelet count \\\u003C 90 × 10⁹\u002FL;\n15. INR \\> 1.5;\n16. Pregnant, breastfeeding, or planning pregnancy within 1 year;\n17. Life expectancy \\\u003C 1 year;\n18. Participation in another drug or device clinical trial currently or planned during the study period;\n19. Intracranial stenosis due to non-atherosclerotic etiology (e.g., arterial dissection, moyamoya disease, vasculitis, active arteritis, thrombosis);\n20. Severe or unstable comorbidities (e.g., severe heart failure, respiratory failure, renal failure \\[serum creatinine \\> 3.0 mg\u002FdL or 264 µmol\u002FL\\], severe hepatic impairment \\[ALT\u002FAST \\> 3 × ULN\\], active malignancy);\n21. Flow-limiting dissection or residual stenosis \\> 50% after pre-dilatation;\n22. Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment;",{"count":58,"type":22},264,[25],"To evaluate the safety and efficacy of the Medeliver® Intracranial Drug-Coated Balloon Catheter (developed by Beijing Jiu Shi Shen Kang Medical Technology Co., Ltd.) in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis.",[28],"RECRUITING","2026-09-06",{"date":65,"type":41},"2026-09-10",{"date":67,"type":41},"2026-04-15",{"date":69,"type":22},"2027-11-30",{"name":71,"class":48},"Xuanwu Hospital, Beijing",15,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100608162","phase-3-drug--eluting-stent-for-symptomatic-intracranial-arterial-stenosis-100608162","NCT07197970","Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis","A Prospective, Multi-center, Randomized Controlled, Clinical Trial to Evaluate the Safety and Efficacy of NxiDIME™ Intracranial Drug-eluting Self-expanding Stent System","DESIAS","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 80 years old, regardless of gender.\n2. Symptomatic intracranial arterial stenosis (TIA\u002Fischemic stroke within 180 days attributed to intracranial arteries including the intracranial internal carotid artery, middle cerebral artery, intracranial vertebral artery, or basilar artery, with stenosis severity ≥70% and ≤99% measured by DSA using WASID criteria), currently receiving at least one antiplatelet therapy;\n3. Poor collateral circulation or hypoperfusion in the target vessel territory (Poor collateral circulation: American Society of Interventional and Therapeutic Neuroradiology\u002FSociety of Interventional Radiology (ASITN\u002FSIR) score \\\u003C 3; Hypoperfusion: 1. The cerebral blood flow (CBF) in the target artery territory decreases by \\> 30% during CT or magnetic resonance perfusion imaging (MR perfusion); or 2. There are hemodynamic ischemic lesions on MRI or CT, such as watershed infarction);\n4. Target lesion vessel diameter 1.0-5.5 mm with lesion length ≤40 mm (If: 2.25 mm ≤ target vessel diameter ≤4.0 mm and lesion length ≤15 mm, enroll in randomized controlled study; 1.0 mm ≤ target vessel diameter \\\u003C2.25 mm or 4.0 mm \\\u003C target vessel diameter ≤5.5 mm or 15 mm \\\u003C lesion length ≤40 mm, enroll in single-arm cohort study);\n5. mRS score ≤ 2;\n6. Patient or legal guardian voluntarily participates and signs the written ICF, with willingness to comply with protocol-specified examinations and follow-up.\n\nExclusion Criteria:\n\n1. History of prior stent implantation or surgical treatment at the target lesion;\n2. Intracranial hemorrhage within 30 days preoperatively or presence of untreated chronic subdural hematoma ≥5 mm;\n3. Major surgical procedure within 30 days prior to the procedure;\n4. Acute ischemic stroke within 14 days prior to the procedure;\n5. Symptomatic carotid stenosis ≥50% outside the target lesion, or coexisting intracranial\u002Fextracranial vascular stenosis ≥70% requiring intervention;\n6. Severe calcification, significant stenosis, or tortuosity of the target vessel precluding device deployment as assessed by investigators;\n7. Intracranial tumor, arteriovenous malformation, or tandem aneurysms proximal\u002Fdistal to the target lesion;\n8. Non-atherosclerotic stenosis etiology (e.g., arterial dissection, moyamoya disease, vasculitis);\n9. Cardiac thromboembolic sources (e.g., atrial fibrillation, left ventricular thrombus, myocardial infarction within 6 weeks);\n10. Uncontrolled hypertension (persistent systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg);\n11. Contraindications to antiplatelet\u002Fanticoagulant therapy, coagulopathy or bleeding diathesis precluding intervention per investigator judgment;\n12. Severe comorbidities: cardiac failure (New York Heart Association (NYHA) Class III-IV), respiratory\u002Frenal failure (serum creatinine \\>3.0 mg\u002FdL (264 μmol\u002FL)), Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) more than 3 times the upper limit of the normal value), active malignancy;\n13. Hypersensitivity to rapamycin, polylactic-co-glycolic acid, nitinol, platinum-tungsten, anesthetics, or contrast agents;\n14. Life expectancy \\\u003C1 year;\n15. Pregnancy, lactation, or planned pregnancy within 1 year;\n16. Concurrent participation in other clinical trials without completing primary endpoint follow-up;\n17. Cognitive impairment or psychiatric disorders compromising protocol compliance; other exclusionary conditions per investigator discretion.",{"count":82,"type":22},224,[84],"PHASE3","This investigation is a prospective, multicenter, randomized controlled, non-inferiority clinical trial, to evaluate the safety and efficacy of the investigational device against alternative models\u002Fspecifications of the control device. The study will be conducted across multiple Chinese centers, with planned enrollment of 224 patients with symptomatic intracranial atherosclerotic stenosis. Subjects meeting all inclusion criteria and without any exclusion criteria will enter the investigation after providing written informed consent via ethics committee-approved informed consent forms (ICFs). The randomized controlled study plans to enroll 224 patients, stratified by intracranial lesion location (anterior\u002Fposterior circulation), through a centralized randomization system. The experimental group will receive the NxiDIME™ Intracranial Drug-Eluting Stent System (RICOTON Technology Co., Ltd.), while the control group will receive the NOVADES® Intracranial Drug-Eluting Stent System.\n\nAll subjects underwent follow-up visits on the day of the procedure, within 7 days postoperatively or prior to discharge, and at 30 days, 6 months, and 12 months postoperatively.",[28],[88,89,90],"symptomatic intracranial atherosclerotic stenosis","Drug-Eluting Stent","strok","2025-09-25",{"date":93,"type":41},"2025-09-30",{"date":95,"type":41},"2025-05-15",{"date":97,"type":22},"2027-05-15",{"name":47,"class":48},1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":19,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":99},"100602162","phase-3-pcsk9-inhibitor-for-intracranial-atherosclerotic-symptomatic-stenosis-100602162","NCT07119918","PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis","PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis (PICASSO): A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Trial","PICASSO","Inclusion Criteria:\n\n1\\. Aged ≥30 years and ≤80 years.\n\nPatients aged between 30 to 49 are required to meet at least one of the following criteria:\n\n1. Insulin dependent diabetes for at least 15 years.\n2. At least 2 of the following atherosclerotic risk factors: hypertension (BP \\> 140\u002F90 or on antihypertensive therapy); dyslipidemia (LDL \\> 130 mg \u002FdL or HDL \\\u003C 40 mg\u002FdL or fasting triglycerides \\> 150 mg\u002FdL or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was \\\u003C 55 years of age for men or \\\u003C 65 for women at the time of the event.\n3. History of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease.\n4. Any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic.\n5. Aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography vi. any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic.\n\n2\\. Diagnosed with acute ischemic stroke or moderate-to-high risk transient ischemic attack (ABCD2 score ≥4).\n\n3\\. CTA or DSA confirmed intracranial atherosclerotic stenosis \\>50%, which was responsible for the incident.\n\n4\\. The time from symptom onset to initiation of study treatment is within 7 days.\n\n5\\. Signed informed consent.\n\nExclusion Criteria:\n\n1. Baseline NIHSS ≥26.\n2. Suspected cardiogenic ischemic cerebrovascular diseases (e.g., combined with atrial fibrillation, heart valve prosthesis, atrial myxoma, endocarditis, etc.).\n3. Source of symptoms is possible related to ipsilateral carotid disease.\n4. Other ischemic cerebrovascular diseases with specific causes (e.g., aortic dissection, vasculitis, vascular malformation, etc.).\n5. Non-cerebral vascular disease (e.g., intracranial tumors, multiple sclerosis).\n6. Hemorrhagic stroke or hemorrhagic transformation of cerebral infarction before randomization.\n7. Pre-existing contraindications of using PCSK9 inhibitors.\n8. Use of any PCSK9 inhibitors within the past 3 months.\n9. Pregnant or childbearing-age women who have no effective contraceptives or positive pregnancy test records.\n10. Patients who are participating in other trials.\n11. Hepatic or renal dysfunction, defined as AST and\u002For ALT \\>3ULN，eGFR\\\u003C30mL\u002Fmin, or Crea \\>220μmol\u002FL (2.5mg\u002FdL).\n12. Uncontrolled hypertension defined as systolic blood pressure (BP) \\>220mmHg or diastolic BP \\>120mmHg.\n13. Life expectancy is less than 1 year due to severe non-cardiovascular disease.\n14. Angioplasty or stenting procedure is planned before randomization.\n15. Unable to finish the follow-up visit due to geographical factor or other reasons (e.g., dementia, alcoholism, substance abuse, severe mental disease, etc.)","30 Years",{"count":110,"type":22},5276,[84],"An investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial comparing the 1-year incidence of stroke in patients with AIS or TIA within 7 days who are treated with either placebo or Recaticimab.",[28],[88,115],"Recaticimab","2025-08-06",{"date":118,"type":41},"2025-08-13",{"date":120,"type":22},"2025-09-01",{"date":122,"type":22},"2029-12-01",{"name":124,"class":48},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"]