[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575414":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":10,"responsibleParty":21,"collaborators":10,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":28,"acronym":10,"eligibilityCriteria":29,"healthyVolunteers":25,"sex":30,"minAge":31,"maxAge":10,"enrollmentInfo":32,"targetDuration":10,"studyType":35,"phases":10,"briefSummary":36,"conditions":37,"keywords":40,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":10},{"fullName":5,"class":6},"Guy's and St Thomas' NHS Foundation Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Immature AVF (requiring BAM)",null,"Cohort to undergo BAM procedure. No additional interventions required.",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Luke H Smith, MSc","CONTACT","+442071886778","luke.smith1@gstt.nhs.uk",{"name":19,"role":15,"phone":16,"phoneExt":10,"email":20},"Soundrie Padayachee, PhD","soundrie.padayachee@gstt.nhs.uk",{"type":22,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100575414","ultrasound-prediction-of-successful-balloon-assisted-avf-maturation-100575414",false,"NCT06771973","Ultrasound Prediction of Successful Balloon Assisted AVF Maturation","A Prospective Cohort Study Analysing Prediction of Successful Arteriovenous Fistula (AVF) Maturation Post Balloon Assisted Fistuloplasty With Duplex Ultrasound and Inflammatory Biomarkers","Inclusion Criteria:\n\n* Adult patients (\\>18 years of age) referred for BAM procedure due to immature native AVF\n* AVFs with radio-cephalic or brachio-cephalic configuration\n* AVF suitable for endovascular BAM procedure\n* Patient is able to provide informed consent\n* Patient is willing and able to comply with the study-related procedures\n\nExclusion Criteria:\n\n* Brachio-basilic AVFs requiring transposition and superficialisation procedures during maturation phase\n* Patients with arterio-venous grafts (AVGs) for vascular access\n* Previous BAM procedures performed to facilitate maturation\n* AVF unsuitable for BAM procedure or BAM procedure not performed","ALL","18 Years",{"count":33,"type":34},40,"ESTIMATED","OBSERVATIONAL","An arteriovenous fistula (AVF) is created to allow for cleaning of the blood in patients with severe kidney disease. An artery and a vein are surgically connected, typically in the arm. This connection changes how the blood flows through the vessels, creating much higher flow in the arm vein than before the operation. Higher blood flow enables blood flow to be cleaned externally with a machine replacing the function of the kidneys. This process is known as dialysis. However, a period known as maturation is required before an AVF can be used in this way. During this time, the vessels grow in size and blood flow continues to increase. In some cases this does not happen and a procedure is required to help the AVF to mature.\n\nAVFs not likely to mature may undergo a procedure, known as balloon assisted maturation (BAM), in which a balloon on the end of a catheter is inserted into the AVF vein and inflated. This is typically needed if an AVF is not likely to develop in a way that can be used for dialysis. Blood cleaning, or haemodialysis, is vital in patients with end stage renal disease, or kidney failure. Blood flow measurement using ultrasound, and routine blood test results, may help us predict which AVFs will respond better to BAM. Ultrasound can be used in the clinic setting and can provide the consultants responsible for the patients ongoing management with information that can enable decisions to be made at an early opportunity, and allowing the participants to be involved in future management decisions. This study aims to identify features of the blood flow following the BAM procedure that might be used to predict if the AVF will successfully mature.",[38,39],"End Stage Renal Disease (ESRD)","Chronic Kidney Disease Requiring Hemodialysis",[41,42,43,44],"arteriovenous fistula","AVF","CKD","ESRD","NOT_YET_RECRUITING","2025-01-14",{"date":48,"type":49},"2025-01-15","ACTUAL",{"date":51,"type":34},"2025-01-13",{"date":53,"type":34},"2026-04-01",{"name":5,"class":6}]