[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aneurysm-intracranial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aneurysm-intracranial":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100603938","the-use-of-p4864-mw-hpc-flow-modulation-device-in-the-treatment-of-wide-necked-intracranial-aneurysms-100603938",false,"NCT07143019","The Use of p48\u002F64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms","p48\u002F64 MW HPC in Aneurysm Occlusion (PIANO): Prospective, Multicenter, Single-arm Clinical Trial to Determine Safety and Effectiveness of the Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms.","PIANO","Inclusion Criteria:\n\n1. Subject is ≥ 18 years\n2. Subject has a mRS ≤2 before the index procedure\n3. Subject has an unruptured or recanalized intracranial aneurysm (IA). The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the index procedure. The IA must have the following characteristics below:\n\n   1. Saccular or fusiform morphology\n   2. Located in the internal carotid artery and its branches\n   3. Aneurysm neck ≥4 mm or dome-to-neck ratio \\\u003C2\n   4. Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA\n4. Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.\n\nExclusion Criteria:\n\n1. Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated\n2. Any other known IA requiring treatment within 3 months post-procedure\n3. Subarachnoid hemorrhage in the past 30 days prior to the index procedure\n4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation\n5. Anatomy unsuitable for endovascular procedure due to severe vessel tortuosity or stenosis, or stented ipsilateral carotid artery within 3 months prior to the index procedure\n6. Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm\n7. Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date\n8. Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)\n9. Known serious sensitivity to radiographic contrast agents that cannot be managed medically\n10. Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components\n11. Irreversible bleeding disorder and\u002For signs of active bleeding at subject presentation\n12. Known renal failure with a serum creatinine \\>2.5 mg\u002Fdl (or 220 μmol\u002Fl) not on dialysis\n13. Contraindication to CT scan, MRI, or angiography\n14. Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor)\n15. Known coagulopathy, or an admission International Normalized Ratio \\>3.0 without oral anticoagulation therapy, or an admission platelet count of \\\u003C100000\n16. Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial\n17. Unable to complete the required study follow-ups\n18. Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count)\n19. Participating in another clinical trial that could affect participation or primary outcomes of this study\n20. Women currently pregnant or wish to become pregnant during the study or breast feeding.","ALL","18 Years",{"count":20,"type":21},214,"ESTIMATED","INTERVENTIONAL",[24],"NA","To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC Flow Modulation Device in the treatment of wide-necked intracranial aneurysms.",[27,28,29,30,31],"Hemorrhagic Stroke","Aneurysm, Intracranial","Saccular Aneurysm","Fusiform Aneurysm","Brain Aneurysm",[33,34,35,36,37,38,39,40],"Neurovascular Intervention","phenox","Brain","Unruptured Aneurysm","Flow diversion","Flow diverter","Occlusion","Flow modulation device","RECRUITING","2026-06-22",{"date":44,"type":45},"2026-06-25","ACTUAL",{"date":47,"type":45},"2026-03-16",{"date":49,"type":21},"2032-07",{"name":51,"class":52},"phenox Inc.","INDUSTRY",21,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100583158","safety-and-efficacy-of-endovascular-treatment-of-intracranial-aneurysms-with-surpass-elite-with-guardian-flow-diverter-guard-100583158","NCT06872684","Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)","Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter","GUARD","Inclusion Criteria:\n\n1. Age is ≥18 and ≤80 years at the time of consent\n2. Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics:\n\n   1. Is located on the internal carotid artery or its branches\n   2. Has a wide neck (wide neck typically defined as neck width ≥ 4 millimeter (mm), or dome to neck ratio ≤ 2.0) or no discernible neck\n   3. Aneurysm is either saccular or fusiform in nature\n3. Has a parent vessel diameter ≥ 3.0 mm to ≤ 6.0 mm at the largest diameter\n4. There is documented risk-benefit of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.\n\nExclusion Criteria:\n\n1. Has an extradural target aneurysm\n2. Has a target aneurysm in the posterior circulation\n3. Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from trial)\n4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation\n5. Has vessel characteristics, such as severe tortuosity (cavernous Internal Carotid Artery (cICA) Type IV1), stenosis (\\>70%), or morphology that would preclude safe endovascular access or proper deployment of the trial device to the target aneurysm\n6. Received previous treatment for the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device\n7. Has a medical contraindication to trial or procedure related antiplatelet medications (aspirin, clopidogrel\u002FPlavix, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye\n8. Has a known severe allergy to nickel, chromium cobalt, tungsten, or platinum\n9. Patients with heparin hypersensitivity, including patients with a previous incident of Heparin-Induced Thrombocytopenia (HIT).\n10. Modified Rankin Score (mRS) assessment is ≥ 3 at pre-procedure exam\n11. Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days prior to the index procedure)\n12. Subarachnoid hemorrhage occurred within 30 days prior to the index procedure\n13. Major surgery (including previous intracranial implant) either occurred within 30 days prior to the index procedure date or is planned to occur within 120 days following the index procedure date\n14. Has more than one intracranial aneurysm (IA) that requires treatment within 12 months after the index procedure\n15. Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 84 days prior to treatment date\n16. Chronic anticoagulation therapy is ongoing or known coagulopathy exists\n17. Has atrial fibrillation with or without pacemaker.\n18. Has other known serious concurrent medical conditions such as cardiovascular disease (including recent myocardial infarction \\[\\\u003C12 weeks\\], symptomatic congestive heart failure, or carotid stenosis), kidney failure (\\>2.0 mg\u002Fdl serum creatinine), pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, terminal cancer, vasculitis, high risk of ischemic stroke or recent stroke\n19. Has acute life-threatening illness (e.g., acute kidney or heart failure) other than the neurological disease to be treated in this trial\n20. Evidence of active infection at the time of treatment\n21. Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)\n22. Unable to comply with the trial follow up requirements due to conditions such as dementia or psychiatric problems, active substance abuse, or history of non-compliance with medical advice, as determined by the investigator\n23. Pregnant or breast- feeding women or women who wish to become pregnant during the length of trial participation\n24. Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm\n25. Enrollment in another study involving an investigational product that could confound the outcomes of this trial","80 Years",{"count":64,"type":21},183,[24],"The objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian Flow Diverter System (FDS) in the treatment of unruptured, wide-neck saccular or fusiform, intracranial aneurysms (IAs) located on the internal carotid artery (ICA) or its branches.",[68,28],"Aneurysm",[29,30,36,70],"Flow Diverter","2026-04-06",{"date":73,"type":45},"2026-04-08",{"date":75,"type":45},"2025-06-20",{"date":77,"type":21},"2031-01-31",{"name":79,"class":52},"Stryker Neurovascular",10,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":92,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100550415","pipeline-embolization-for-intracranial-aneurysms-100550415","NCT06446778","Pipeline Embolization for Intracranial Aneurysms","Pipeline Embolization Device for Intracranial Aneurysm (PEDIA): a Prospective, Multicenter Cohort Focus on Safety, Efficacy, and Haemodynamics","Inclusion criteria:\n\n1. Aged 22 to 75 years old, male or non-pregnant female;\n2. UIA was diagnosed by CTA, MRA, or DSA;\n3. The size of aneurysms is between 3 to 25mm;\n4. Understands the nature of the procedure and provision of written informed consent;\n5. Indications for FD implantation with or without adjunctive coiling;\n6. Is willing to return to the investigational site for follow-up according to our protocol.\n\nExclusion criteria:\n\n1. With contraindications to flow-diversion treatment or known allergy to cobalt-chromium alloy or contrast medium;\n2. Pregnancy or lactation;\n3. Coexist with other vascular lesions (coronary artery disease, abdominal aortic aneurysm, severe intracranial artery stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);\n4. Parent vessel with a diameter \\\u003C2.0 mm or ≥5.0 mm.;\n5. Unwilling to be followed up or likely to have poor treatment compliance;\n6. Life expectancy less than 3 years;\n7. Inability to receive anti-platelet or anticoagulant medication;\n8. Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4);\n9. Enrollment in another trial or other situations that the researcher deems unsuitable for inclusion in the study.","22 Years","75 Years",{"count":91,"type":21},1000,"3 Years","OBSERVATIONAL","This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization.",[96,97,98,28],"Efficacy, Self","Hemodynamic Instability","Stenosis",[100,101,102,103],"intracranial aneurysms","flow-diverter device","Pipeline embolization device","in-stent stenosis","2024-11-13",{"date":106,"type":45},"2024-11-18",{"date":108,"type":45},"2022-09-01",{"date":110,"type":21},"2030-09-01",{"name":112,"class":113},"Zhujiang Hospital","OTHER",1]