[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100393201":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":28,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":44,"whyStopped":28,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Boston Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IVUS and venography group","EXPERIMENTAL","Participants in the this group will receive venography\u002Ffistulogram, intravascular ultrasound (IVUS), and image processing.",[13,14,15],"Diagnostic Test: Venography","Diagnostic Test: Intravascular ultrasound (IVUS)","Other: Image processing",[17,24,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIAGNOSTIC_TEST","Venography","The venography will be performed as part of the patient's standard of care. The dialysis access will be punctured upstream of the arteriovenous anastomosis in AVF or AVG using a 4-F coaxial access set (Micro- puncture; Cook, Inc, Bloomington, Indiana). The contrast will be injected intravenously by a pump with 200 psi and a bolus of 2m\u002Fsec for total of 5 ml during upper extremity vein filming and 10 ml of contrast bolus by 3 ml\u002Fs during central vein filming while holding the breath in inspiration in anterioposterior plane.",[9],[23],"Fistulogram",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Intravascular ultrasound (IVUS)","IVUS will be performed through the same sheath of the coaxial access set using an Eagle Eye Platinum RX digital catheter 7F over a compatible guidewire under fluoroscopic guidance. The lesion will be estimated fluoroscopically from the marker IVUS catheter in the vein and the cranial and caudal margins of stenotic lesion will be directly visualized during pullback of the IVUS catheter.",[9],null,{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Image processing","Image processing will be performed by two radiologists in a blinded manner on the images devoid of personal identifier. An adjudication committee will oversee the process and confirm their findings in case of a discrepancy.",[9],[34],{"name":35,"affiliation":5,"role":36},"Vipul Chitalia, MD PhD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":28,"email":41},"CONTACT","617 638 7330","vipul.chitalia@bmc.org",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Boston","Massachusetts","02118","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.05977,42.35843,{"lat":54,"lon":53},[57],{"name":35,"role":39,"phone":28,"phoneExt":28,"email":41},{"type":59,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[61],{"name":62,"class":63},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100393201","intravascular-ultrasound-in-patients-with-end-stage-renal-disease-on-dialysis-100393201",false,"NCT04399941","Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis","Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis","IVUS in ESRD","Inclusion Criteria:\n\n* ESRD (end stage renal disease) patients at BMC (Boston Medical Center)\n* Receiving hemodialysis\n* Has a dialysis access malfunction\n* Undergoing a diagnostic fistulogram for the dialysis access malfunction\n\nExclusion Criteria:\n\n* None","ALL","18 Years","85 Years",{"count":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"NA","Hemodialysis represents a life line of patients with end stage renal disease, who are commonly maintained on hemodialysis through catheters. Prolonged exposure to these catheters eventually damages the walls of veins, which results in stenosis at the local site. This condition is called central venous stenosis (CVS) and affects number of patients on hemodialysis in the United States and can compromise the dialysis efficacy. The current diagnostic modality for CVS is venography, which has several limitations. This study proposes to examine intravenous ultrasound (IVUS) as a potentially superior modality, which will provide additional information.",[83],"End Stage Renal Disease",[85,86,87,88,89,90,91],"intravenous ultrasound (IVUS)","central venous stenosis (CVS)","hemodialysis","dialysis access malfunction","fistulogram","stenosis","virtual histology (VH-IVUS) software","2025-11-26",{"date":94,"type":95},"2025-12-01","ACTUAL",{"date":97,"type":95},"2021-08-03",{"date":99,"type":77},"2026-09",{"name":5,"class":6},1]