[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arteriovenous-shunt-thrombosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arteriovenous-shunt-thrombosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"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":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Arteriovenous Shunt Thrombosis","Blood Vessel Prosthesis",[31,32,33,34,35],"Arteriovenous graft","Thrombosis","Sirolimus","Drug-coated balloon","stent graft","RECRUITING","2023-12-19",{"date":39,"type":40},"2023-12-26","ACTUAL",{"date":42,"type":40},"2023-11-01",{"date":44,"type":22},"2026-08",{"name":46,"class":47},"Singapore General Hospital","OTHER"]