[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intracranial-arteriovenous-malformations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intracranial-arteriovenous-malformations":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100341854","phil-embolic-system-pediatric-ide-100341854",false,"NCT03731000","PHIL® Embolic System Pediatric IDE","Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population","Inclusion Criteria:\n\n* Subject is \\\u003C22 years of age\n* Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified follow-up period.\n* Subject's legally authorized representative(s) must sign and date an IRB approved written informed consent prior to initiation of any study procedure\n* Subject has an intracranial dAVF that is deemed appropriate for embolization with PHIL without significantly increased risk to collateral or adjacent territories, OR subject has been previously treated with other embolic materials for dAVF.\n\nExclusion Criteria:\n\n* Subject presents with an intracranial mass or is currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region\n* Subject has known allergies to DMSO (dimethyl sulfoxide), iodine or heparin.\n* Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).\n* Female subject is currently pregnant.\n* Subject has an acute or chronic life-threatening illness other than the neurological disease to be treated in this study including but not limited to any malignancy or debilitating autoimmune disease\n* Subject has existing severe or advanced comorbid conditions which significantly increase general anesthesia and\u002F or surgical risk\n* Evidence of active infection at the time of treatment.\n* Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.\n* Subject weighs ≤ 2.5kg Angiographic\n* Subject has severe calcification or vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, or access to the lesion with the microcatheter.\n* Contra-indication to DSA, CT scan or MRI\u002F MRA\n* History of intracranial vasospasm not responsive to medical therapy\n* Extra-cranial stenosis or parent vessel stenosis \\> 50% proximal to the target lesion to be treated.\n* Subject has a propensity to contrast induced renal injury or a potential to nephrogenic systemic fibrosis","ALL","21 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs.\n\nThe PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.",[26,27],"Arterio-venous Fistula","Intracranial Arteriovenous Malformations",[29],"Pediatric","RECRUITING","2026-03-23",{"date":33,"type":34},"2026-03-27","ACTUAL",{"date":36,"type":34},"2019-04-16",{"date":38,"type":20},"2027-12",{"name":40,"class":41},"Alejandro Berenstein","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100552919","efficacy-and-safety-of-the-liquid-embolic-system-tonbridge-for-endovascular-treatment-of-cerebrovascular-malformations-100552919","NCT06479343","Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations","Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations: a Prospective, Multi-center, Randomized, Parallel Positive Controlled, Non-inferiority Trial","Inclusion Criteria:\n\n* Age 18 to 80 years, any gender;\n* Subject is suitable for endovascular treatment of cerebrovascular malformations;\n* Subject is able to understand the purpose of the study, shows sufficient compliance with the study protocol and provides a signed informed consent form.\n\nExclusion Criteria:\n\n* Intracranial hemorrhage within 1 month prior to treatment;\n* The targeted embolization area needs to receive other treatments (surgical resection, SRS, other embolic materials) at the same time;\n* Combination of other cerebrovascular malformations, such as cavernous vascular malformation;\n* Severe stenosis or occlusion of cerebral feeding artery requiring surgical intervention;\n* Intracranial tumor requiring surgical intervention;\n* mRS score≥3;\n* Heart, lung, liver and renal failure or other severe diseases;\n* Known bleeding tendency, such as coagulation dysfunction (INR\\>1.5);\n* Known allergy to DMSO and contrast media, or contraindication to anticoagulant therapy;\n* Pregnant or breastfeeding women, or who plan to become pregnant during the study;\n* Subject is participating in other drug or medical device clinical trials at the time of signing informed consent;\n* Other conditions judged by the investigators as unsuitable for enrollment.","18 Years","80 Years",{"count":53,"type":20},170,[23],"The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd. (Suzhou)) for the treatment of cerebrovascular malformations.",[27],"2024-09-03",{"date":59,"type":34},"2024-09-19",{"date":61,"type":34},"2024-06-27",{"date":63,"type":20},"2026-10",{"name":65,"class":66},"Ton-Bridge Medical Tech. Co., Ltd","INDUSTRY",14]