[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558617":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":50,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":25,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":34,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Singapore General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug-coated balloon","EXPERIMENTAL","Ranger drug-coated balloon will be used for all peripheral AVF stenosis.",[13],"Device: Angioplasty of all peripheral AVF stenosis",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional balloon","ACTIVE_COMPARATOR","Conventional balloon will be used for all peripheral AVF stenosis.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Angioplasty of all peripheral AVF stenosis","All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Arjunana Sarupraba","CONTACT","6222 3322","arjunana.sarupraba@sgh.com.sg",[33],{"facility":5,"status":34,"city":35,"state":25,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Singapore","SG",{"type":38,"coordinates":39},"Point",[40,41],103.85007,1.28967,{"lat":41,"lon":40},[44,45],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},{"name":46,"role":47,"phone":25,"phoneExt":25,"email":25},"Kun Da Zhuang, MBBS","PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[51,53],{"name":52,"class":6},"Singapore Clinical Research Institute",{"name":54,"class":55},"Boston Scientific Corporation","INDUSTRY","100558617","phase-3-randomised-clinical-trial-comparing-drug-coated-balloon-to-plain-balloon-for-all-peripheral-avf-stenosis-100558617",false,"NCT06553443","Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis","RANGER","Inclusion Criteria:\n\n1. Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.\n2. AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).\n3. Less than 30% residual stenosis after angioplasty.\n4. ≥ 21 years old\n5. Informed and valid consent given.\n\nExclusion Criteria:\n\n1. Thrombosed AVFs\n2. Haemodynamically significant central vein stenosis\n3. Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)\n4. Contraindication to antiplatelet therapy\n5. Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.\n6. Allergy \u002F contraindication to paclitaxel.\n7. Acute infection over proposed puncture site.\n8. Women who are breastfeeding, pregnant \\* or planning on becoming pregnant during study.\n9. Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.\n10. Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.","ALL","21 Years",{"count":66,"type":67},94,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty",[73,74,75],"Arteriovenous Fistula","Arteriovenous Fistula Stenosis","Dialysis Access Malfunction",[77,78],"drug-coated balloon","access circuit patency","2024-08-11",{"date":81,"type":82},"2024-08-14","ACTUAL",{"date":84,"type":82},"2024-01-04",{"date":86,"type":67},"2029-12-31",{"name":5,"class":6},1]