[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arterio-venous-fistula\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arterio-venous-fistula":26},{"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":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":42},"100618376","a-first-in-man-study-to-assess-safety-and-efficacy-of-ultra-high-pressure-pta-balloon-ultraviolet-in-treating-a-v-fistula-stenosis-100618376","NCT07330817","A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis","ULTRAVIOLET FIM_A First-In-Man Single Arm Prospective Single Center Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis","ULTRAVIOLETFIM","Inclusion Criteria:\n\n* Patients able to understand the purpose of the study, voluntarily agree to participate and signed Informed Consent form\n* Patients with impaired haemodialysis access due to narrowed lesions, as indicated by contrast or ultrasound or clinical diagnosis.\n* Indications for percutaneous endovascular therapy with diameter stenosis \\>50% and fistula's hemodynamic showing abnormalities (thrombosis in the AVF, high venous pressure, re-circulation, abnormal physical examination, decrease in dialysis efficiency, decrease in blood flow through the vascular access)\n* Target lesion is a resistant de novo or restenotic lesion\n* The target lesion is located in the reflux vein from the anastomotic site of arteriovenous fistula (AVF) to the distal end of the subclavian vein (excluding the anastomotic site of AVF); if there are no target lesions, they should be treated with standard angioplasty balloon before treating the target lesion.\n\nExclusion Criteria:\n\n* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study;\n* Patients who are actively participating in another drug or device investigational study, who have not completed the primary endpoint follow-up period;\n* Patients who have undergone major surgical procedures (such as open chest surgery, head surgery) within 30 days before being enrolled in the study;\n* Patients who plan to undergo major surgical procedures (such as open chest surgery, head surgery) within 30 days after being enrolled in the study;\n* Immature AVF (not used for dialysis; due to insufficient inner diameter, inability to ensure successful puncture, and inadequate blood flow, this access has not been used for successful dialysis);\n* AVF has been implanted with a stent.","18 Years",{"count":53,"type":20},35,[23],"First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.",[26,57],"Stenosis of Arteriovenous Dialysis Fistula",[59,60,61,62,63],"A-V fistula","First-In-Man","Ultra-High Pressure Balloon","PTA balloon","Resistant Stenotic Fistula","NOT_YET_RECRUITING","2025-12-29",{"date":67,"type":34},"2026-01-09",{"date":69,"type":20},"2026-02",{"date":71,"type":20},"2027-02",{"name":73,"class":74},"Cardionovum GmbH","INDUSTRY"]