[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646736":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":23,"locations":23,"responsibleParty":24,"collaborators":23,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":23,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":23,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":45,"overallStatus":54,"whyStopped":23,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":23},{"fullName":5,"class":6},"Kaneka Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"i-ED Coil \u002F Electro-detach Generator v4","EXPERIMENTAL","Participants with arteriovenous malformations (AVMs) will undergo endovascular coil embolization using the i-ED Coil in combination with the Electro Detach Generator v4 (EDG v4). The study will collect safety and performance data during follow-up.",[13],"Device: Endovascular Coil Embolization",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Endovascular Coil Embolization","Endovascular embolization performed using the i-ED Coil, a detachable platinum coil system, in combination with the Electro Detach Generator v4 (EDG v4).",[9],[21,22],"i-ED Coil","EDG v4",null,{"type":25,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100646736","post-market-clinical-follow-up-study-of-i-ed-coil-and-edg-v4-for-arteriovenous-malformation-100646736",false,"NCT07687472","Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation","Safety and Efficacy of i-ED Coil and EDG v4 for Arteriovenous Malformation - A Prospective Study","Inclusion Criteria:\n\n* Subjects aged 18 to \\\u003C80 years\n* Subjects requiring endovascular treatment using coils for arteriovenous malformation\n* Free and informed consent to participate in the investigation obtained from the subject or an acceptable subject representative\n\nExclusion Criteria:\n\n* Coiling or stenting performed on the non-target lesion within 30 days prior to treatment of the target lesion\n* Hunt and Hess score of 3 or higher or modified Rankin Score (mRS) of 4 or higher\n* Subjects with contraindications to CT or MRI procedures\n* Subjects with contraindications to angiography procedures\n* Pregnant or breastfeeding subjects","ALL","18 Years","79 Years",{"count":37,"type":38},36,"ESTIMATED","INTERVENTIONAL",[41],"NA","This is a prospective, multicenter, post-market clinical follow-up (PMCF) study to collect safety and performance data in patients with arteriovenous malformations (AVMs) who undergo endovascular coil embolization using the i-ED Coil and Electro Detach Generator v4 (EDG v4).",[44],"Arteriovenous Malformation (AVM)",[46,47,48,49,50,21,51,22,52,53],"Arteriovenous Malformation","AVM","Endovascular Embolization","Coil Embolization","Detachable Coil","Electro Detach Generator v4","Post-Market Clinical Follow-up","PMCF","NOT_YET_RECRUITING","2026-07-01",{"date":57,"type":58},"2026-07-07","ACTUAL",{"date":60,"type":38},"2026-10-01",{"date":62,"type":38},"2033-09-30",{"name":5,"class":6}]