[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100157454":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":35,"responsibleParty":49,"collaborators":26,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":26,"enrollmentInfo":61,"targetDuration":26,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":73,"whyStopped":74,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Nīmes","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","Patients in this arm will have angioplasty of a fistula stenosis using a cutting balloon",[13],"Procedure: Cutting balloon angioplasty",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard arm","ACTIVE_COMPARATOR","Patients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon.",[19],"Procedure: Angioplasty",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Cutting balloon angioplasty","Angioplasty of fistula stenosis using a cutting balloon",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Angioplasty","Angioplasty of fistula stenosis using a non-cutting balloon",[15],[32],{"name":33,"affiliation":5,"role":34},"Eric Picard, MD","PRINCIPAL_INVESTIGATOR",[36],{"facility":37,"status":26,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"Centre Hospitalier Universitaire de Nîmes","Nîmes","Gard","30029","France","FR",{"type":44,"coordinates":45},"Point",[46,47],4.35788,43.83665,{"lat":47,"lon":46},{"type":50,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100157454","cutting-balloon-versus-non-cutting-balloon-for-the-treatment-of-venous-stenosis-in-the-fistulas-of-hemodialyzed-patients-100157454",false,"NCT01321866","Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients","Randomized Trial Comparing a Cutting Balloon to a Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients","PREST","Inclusion Criteria:\n\n* The patient must have given his\u002Fher informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 12 months of follow-up\n* The patient is on hemodialysis because of chronic renal insufficiency\n* The patient's vascular access is an arterio-venous fistula\n* The patient has a venous stenosis in the fistula (first event in the studied zone)\n* The patient is scheduled for angioplasty\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient cannot fluently read French\n* The patient cannot understand French\n* The patient is pregnant\n* The patient is breastfeeding\n* Short term dialysis\n* The vascular access is a \"graft\"\n* The stenosis in question is a recurrence, and not a first event in the studied zone\n* The life expectancy of the patient is \\\u003C 12 months\n* Medical emergency situation\n* Peritoneal dialysis\n* At-home dialysis","ALL","18 Years",{"count":62,"type":63},42,"ACTUAL","INTERVENTIONAL",[66],"NA","The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.",[69,70],"Arteriovenous Fistula","Fistula",[28,72],"cutting balloon","TERMINATED","Inclusion curve too slow.","2016-06-02",{"date":77,"type":78},"2016-06-03","ESTIMATED",{"date":80,"type":26},"2012-05",{"date":82,"type":63},"2015-12",{"name":5,"class":6},1]