[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511368":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":25,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Singapore General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sirolimus drug-coated balloon","EXPERIMENTAL","The trial product is MagicTouch sirolimus drug coated balloon (Concept Medical). Sirolimus will be transferred from the balloon to the graft vein junction by inflating the balloon for 2 minutes at rated burst pressure (typically 12 to 14ATM).",[13],"Device: Sirolimus drug-coated balloon",{"label":15,"type":16,"description":17,"interventionNames":18},"Stent graft","ACTIVE_COMPARATOR","Stent graft is the current standard of care for treatment of arteriovenous graft malfunction. A stent graft will be deployed at the graft vein junction.",[19],"Device: Stent graft",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The effectiveness of sirolimus coated balloon in patients with dialysis access dysfunction has been shown in a small pilot study in the salvage of thrombosed arteriovenous graft.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Stent graft has been shown to be superior than plain balloon angioplasty in the treatment of AVG dysfunction.",[15],[30],{"name":31,"affiliation":5,"role":32},"Ru Yu Tan","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","+6563214436","tan.ru.yu@singhealth.com.sg",[39],{"facility":5,"status":40,"city":41,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Singapore","SG",{"type":44,"coordinates":45},"Point",[46,47],103.85007,1.28967,{"lat":47,"lon":46},[50,51,54,56,58,60,62,64,66,68,70],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},{"name":52,"role":53,"phone":25,"phoneExt":25,"email":25},"Chieh Suai Tan, MD","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":25,"phoneExt":25,"email":25},"Suh Chien Pang, MD",{"name":57,"role":53,"phone":25,"phoneExt":25,"email":25},"Alvin Ren Kwang Tng, MD",{"name":59,"role":53,"phone":25,"phoneExt":25,"email":25},"Chee Wooi Tan, MD",{"name":61,"role":53,"phone":25,"phoneExt":25,"email":25},"Tze Tec Chong, MD",{"name":63,"role":53,"phone":25,"phoneExt":25,"email":25},"H'sien Tsung Tay, MD",{"name":65,"role":53,"phone":25,"phoneExt":25,"email":25},"Hao Yun Yap, MD",{"name":67,"role":53,"phone":25,"phoneExt":25,"email":25},"Kiang Hiong Tay, MD",{"name":69,"role":53,"phone":25,"phoneExt":25,"email":25},"Apoorva Gogna, MD",{"name":71,"role":53,"phone":25,"phoneExt":25,"email":25},"Kun Da Zhuang, MD",{"type":73,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[75],{"name":76,"class":77},"National Medical Research Council (NMRC), Singapore","OTHER_GOV","100511368","sirolimus-drug-coated-balloon-versus-stent-graft-100511368",false,"NCT05938530","Sirolimus Drug-coated Balloon Versus Stent Graft","Sirolimus Drug-coated Balloon Versus Stent Graft for Thrombosed Arteriovenous Graft (SUSTAIN)","SUSTAIN","Inclusion Criteria:\n\n* Thrombosed AVG in the upper arm\n* Successful thrombolysis of the thrombosed AVG, defined as the re-established of flow on Digital Subtraction Angiography (DSA) and restoration of thrill in the AVG on clinical examination (to be determined during procedure)\n\nExclusion Criteria:\n\n* Patient unable to provide informed consent\n* Previous bare metal stent or stent-graft placement within the dialysis access\n* Previous treatment with DCB within 3 months\n* Presence of central vein stenosis which cannot be adequately treated (residual recoil of more than 30%)\n* Failure to re-establish blood flow\n* Failure to adequately treat the GV junction (defined as residual stenosis of more than 30%)\n* Sepsis or active infection\n* Recent intracranial bleed or gastrointestinal bleed within the past 12 months\n* Allergy to iodinated contrast media, anti-platelet drugs, heparin or sirolimus\n* Pregnancy\n* Life expectancy \\\u003C 12 months based on physician's estimate (eg. active malignancy)","ALL","21 Years","85 Years",{"count":90,"type":91},100,"ESTIMATED","INTERVENTIONAL",[94],"NA","A functioning dialysis vascular access is critical to the delivery of lifesaving hemodialysis. Arteriovenous graft (AVG) is a surgically created vascular access used for hemodialysis in patients with end-stage renal disease. AVG thrombosis due to underlying flow-limiting stenosis of the graft vein junction and outflow veins is a common complication. Thrombosed AVG can be treated with thrombolysis combined with percutaneous transluminal angioplasty with good immediate success rates. However, the mid-to-long term patency rates following angioplasty have been suboptimal. Sirolimus drug-coated balloon has been shown to be safe and effective in the salvage of thrombosed arteriovenous graft. The investigators hypothesize that sirolimus drug-coated balloon is non-inferior to stent graft in maintaining the patency of thrombosed AVG that is successfully salvaged. This study is conducted to compare the 6-month access circuit primary patency of thrombosed AVG treated with sirolimus drug-coated balloon versus stent graft.",[97,98],"Arteriovenous Shunt Thrombosis","Blood Vessel Prosthesis",[100,101,102,103,104],"Arteriovenous graft","Thrombosis","Sirolimus","Drug-coated balloon","stent graft","2023-12-19",{"date":107,"type":108},"2023-12-26","ACTUAL",{"date":110,"type":108},"2023-11-01",{"date":112,"type":91},"2026-08",{"name":5,"class":6},1]