[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemodialysis-access-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemodialysis-access-failure":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,84,123,150,178,206,230,247,266,284],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100548582","preserve-hd-observational-study-of-the-merit-hero-graft-and-super-hero-in-patients-on-hemodialysis-100548582",false,"NCT06422871","PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis","PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis","PReSeRVE-HD","Key Inclusion Criteria:\n\n* Subject provides written informed consent\n* Subject is ≥ 18 years\n* Subject is end-stage renal disease patient on hemodialysis.\n* Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU)\n\nKey Exclusion Criteria:\n\n* Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement\n* Subject has a topical or subcutaneous infection associated with the implantation site\n* Subject has known or suspected systemic infection, bacteremia or septicemia","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","2 Years","OBSERVATIONAL","The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. If participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.",[26,27],"End Stage Renal Disease","Hemodialysis Access Failure",[29],"HeRO","RECRUITING","2026-05-28",{"date":33,"type":34},"2026-06-01","ACTUAL",{"date":36,"type":34},"2025-07-28",{"date":38,"type":21},"2028-12-28",{"name":40,"class":41},"Merit Medical Systems, Inc.","INDUSTRY",7,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100624031","phase-4-low-dose-apixaban-added-to-standard-heparin-lock-versus-heparin-lock-alone-to-prevent-tunneled-hemodialysis-catheters-dysfunction-apicath-hd-100624031","NCT07404345","Low-Dose Apixaban Added to Standard Heparin Lock Versus Heparin Lock Alone to Prevent Tunneled Hemodialysis Catheters Dysfunction (APICATH-HD)","Efficacy of Low-Dose Apixaban Added to Standard Heparin Lock to Prevent Dysfunction of Tunneled Hemodialysis Catheters: A Randomized, PROBE, Parallel-Grupo Trial.","APICATH-HD","Inclusion Criteria:\n\n* Age ≥18 years with end-stage kidney disease (CKD stage 5) receiving maintenance hemodialysis or initiating hemodialysis.\n* Recently placed tunneled, double-lumen central venous hemodialysis catheter (tunneled CVC) in place for ≥8 days, with a post-placement radiograph confirming adequate tip position.\n* Permitted catheter insertion sites: right internal jugular, left internal jugular, right femoral, or left femoral vein.\n* Adequate initial catheter function, defined as ability to achieve the prescribed extracorporeal blood flow (suggested ≥300 mL\u002Fmin) for ≥8 days after catheter placement.\n* Conventional in-center hemodialysis schedule (2-3 sessions\u002Fweek) at the study unit, with expected ability to complete follow-up for up to 24 months.\n* Written informed consent provided.\n* Willingness to receive only the protocol-assigned antithrombotic prophylaxis and to avoid non-study systemic anticoagulants or antiplatelet agents during the study period.\n\nExclusion Criteria:\n\n* Non-tunneled hemodialysis catheter, subclavian catheter, or intracaval catheter placement not consistent with the protocol (e.g., catheter located in the SVC\u002FIVC without a subcutaneous tunnel, or catheter location\u002Fsite not permitted by the study).\n* Tunneled catheter placed \\\u003C8 days before randomization or radiographically confirmed catheter tip malposition at screening.\n* Active bleeding; active peptic ulcer disease; or clinically significant gastrointestinal bleeding within the past 30 days; uncorrectable INR \\>1.5; platelet count \\\u003C100,000\u002FµL.\n* High bleeding risk (HAS-BLED score \\>3) or major bleeding that is active or recent.\n* Known coagulopathy; history of heparin-induced thrombocytopenia (HIT); or allergy\u002Fhypersensitivity to heparin, citrate, or rt-PA (alteplase).\n* Severe hepatic impairment (e.g., Child-Pugh class C), clinically significant liver dysfunction that contraindicates DOAC therapy, or ongoing hemodialysis with regional citrate anticoagulation that cannot be modified per protocol.\n* Active catheter exit-site infection or bloodstream infection\u002Fbacteremia at the time of randomization.\n* Concomitant use of other systemic anticoagulants (e.g., warfarin, low-molecular-weight heparin, other DOACs) or high-intensity antiplatelet therapy (e.g., dual antiplatelet therapy).\n* Pregnancy or breastfeeding.\n* Women of childbearing potential who are unwilling to use a highly effective contraception method during the study and for 48 hours after the last dose of study medication.\n* Life expectancy \\\u003C6 months, current palliative\u002Fhospice care, or planned kidney transplant within ≤3 months.\n* Concurrent participation in another clinical trial that could interfere with the study interventions or outcomes.\n* Venography demonstrating significant venous stenosis involving the superior vena cava (SVC) or inferior vena cava (IVC).",{"count":52,"type":21},54,"INTERVENTIONAL",[55],"PHASE4","This randomized, single-center, PROBE trial evaluates whether adding low-dose apixaban (2.5 mg orally every 12 hours) to standard intraluminal heparin lock prolongs primary functional patency of tunneled hemodialysis catheters compared with standard heparin lock alone. Adult patients on hemodialysis with a recently implanted, functioning tunneled catheter (≥8 days) will be randomized 1:1 and followed up to 24 months (or until catheter loss). Primary outcome is time to first intervention for catheter dysfunction or definitive catheter loss. Secondary outcomes include primary-assisted and secondary patency, thrombotic dysfunction, rescue procedures, catheter-related infection, bleeding (ISTH), and mortality. Outcomes adjudication will be blinded.",[27,58,59],"Kidney Disease, End-Stage","Hemodialysis Catheter",[61,62,63,64,65,66,67,68,69,70,71],"Hemodialysis","Tunneled central venous catheter","Catheter dysfunction","Catheter Failure","Catheter thrombosis","Apixaban","Heparin lock","End-stage kidney disease","Vascular access","Anticoagulation","PROBE trial","NOT_YET_RECRUITING","2026-02-12",{"date":75,"type":34},"2026-02-17",{"date":77,"type":21},"2026-03-01",{"date":79,"type":21},"2028-09-01",{"name":81,"class":82},"Hospital Civil de Guadalajara","OTHER",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":53,"phases":93,"briefSummary":95,"conditions":96,"keywords":105,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100516231","save-fistulas-the-selfwrap-assisted-arteriovenous-fistulas-study-100516231","NCT06001827","SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study","SAVE-FistulaS","Inclusion Criteria:\n\n* Age of at least 18 years\n* Referred for creation of a new AVF\n* Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months\n\nExclusion Criteria:\n\n* Planned index procedure to revise or repair an existing fistula\n* Target artery inner diameter \\\u003C 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia\n* Target vein inner diameter \\\u003C 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia\n* Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound\n* Known central venous stenosis of at least 50% on the side of surgery\n* Presence of a stent or a stent graft within the access circuit\n* Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation\n* Known or suspected active infection at the time of surgery\n* Congestive heart failure NYHA class 4\n* Prior steal on the side of surgery;\n* Enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study\n* Life expectancy less than 12 months\n* Expected to undergo kidney transplant surgery within 6 months of enrollment\n* Expected to undergo home hemodialysis\n* Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening\n* Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study\n* Unwillingness or inability to give consent and\u002For comply with the study follow up schedule\n* Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study.",{"count":92,"type":21},600,[94],"NA","This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.",[97,26,98,27,99,100,101,102,103,104],"Chronic Kidney Diseases","Arteriovenous Fistula","ESRD","Vascular Access Complication","Renal Failure","Catheter Complications","Catheter Dysfunction","Renal Insufficiency",[106,107,108,109,110,111,61,112,113,26,98,114],"Vascular Surgery","Vascular Access","Nephrology","Bioabsorbable","Perivascular Wrap","External Support","Dialysis","Chronic Kidney Disease","AVF",{"date":75,"type":34},{"date":117,"type":34},"2024-01-03",{"date":119,"type":21},"2029-12",{"name":121,"class":41},"VenoStent",28,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":53,"phases":133,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100598060","evaluating-the-effect-of-the-valsalva-maneuver-on-invasive-pain-during-arteriovenous-fistula-cannulation-in-hemodialysis-patients-100598060","NCT07066579","Evaluating the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients","Evaluation of the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients","VALPAIN-HD","Inclusion Criteria:\n\n* Age 18 years or older\n* Receiving hemodialysis treatment via arteriovenous fistula for at least 3 months\n* No analgesic medication use within the past 24 hours\n* Systolic blood pressure between 90-160 mmHg and diastolic between 60-100 mmHg\n* Pain score ≥ 1 on Visual Analogue Scale during AVF cannulation\n* Able to perform the Valsalva maneuver (no contraindications)\n* No communication barriers or severe psychiatric disorders\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Unable to correctly perform the Valsalva maneuver\n* Failed first cannulation attempt\n* History of acute myocardial infarction or malignant arrhythmia\n* Aneurysm, infection, edema, or scar tissue at AVF site\n* Pregnancy\n* Voluntary withdrawal from the study at any stage\n* Switching dialysis centers or requiring hospitalization during the study",{"count":132,"type":21},60,[94],"The goal of this clinical trial is to evaluate whether the Valsalva maneuver reduces invasive pain during arteriovenous fistula (AVF) cannulation in adult hemodialysis patients. The main questions it aims to answer are:\n\nDoes the Valsalva maneuver effectively reduce pain intensity during AVF cannulation as measured by the Visual Analogue Scale (VAS)?\n\nIs the Valsalva maneuver feasible, acceptable, and satisfactory for patients, and can it be sustainably implemented over multiple sessions?\n\nResearchers will compare patients performing the Valsalva maneuver (intervention group) with those receiving standard care without any intervention (control group) to see if pain scores are significantly lower and whether patients are willing to continue using this technique voluntarily.\n\nParticipants will:\n\nReceive training and supervised practice on the Valsalva maneuver before inclusion in the study\n\nPerform the Valsalva maneuver during AVF cannulation in each hemodialysis session for 12 sessions\n\nComplete VAS pain assessments after each session\n\nComplete a patient satisfaction and feasibility form at the end of the study",[98,136,27,137],"Pain","Vascular Access Device Complications",[61,98,139,140],"Cannulation Pain","Valsalva Maneuver","2025-07-05",{"date":143,"type":34},"2025-07-15",{"date":145,"type":21},"2025-09-01",{"date":147,"type":21},"2026-09-01",{"name":149,"class":82},"Cansu POLAT DÜNYA",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":157,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":53,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":83},"100588927","skill-building-education-of-arteriovenous-fistula-self-care-behaviors-and-quality-of-life-of-patients-on-hemodialysis-100588927","NCT06947772","Skill Building Education of Arteriovenous-Fistula Self-Care Behaviors and Quality of Life of Patients on Hemodialysis","Effectiveness of Skill Building Education on Arteriovenous Fistula Self-Care Behaviors and Quality of Life of Patients on Hemodialysis","Inclusion Criteria:\n\n* Inclusion Criteria\n\nThe study will include patients:\n\n1. diagnosed with end-stage renal disease on hemodialysis through an arteriovenous fistula\n2. aged 18 years or above.\n3. who can read and understand the Urdu language.\n\nExclusion Criteria:\n\nExclusion Criteria\n\nThe study will exclude patients:\n\n1. having any physical or mental disabilities that can interfere with their capacity to perform daily life activities.\n2. with any visual and hearing impairment. -","18 Months",{"count":159,"type":21},274,[94],"The purpose of this study is to assess the effectiveness of skill building educational interventions in improving the self-care behaviors and quality of life of AVF in hemodialysis patients. This study will address questions.\n\nWhat is the effect of skill building education on the self-care behaviors of AVF care and quality of life in patients in patients undergoing hemodialysis treatment? A total 274 participants will be recruited from dialysis units of the study hospitals. Using random allocation 137 participants will be assigned to the control group and 137 to the intervention group. The intervention group will additionally receive a skill building education for improving their self-care behaviors and quality of life of AVF.\n\nResearcher will implement skill building educational intervention in interventional group to enhance the self-care behaviors and quality of life. This intervention have two session, first is theoretical and another one is practical. The primary outcome of this study is AVF self-care behaviors and secondary outcome is quality of life related to AVF. This outcome will be assessed using the Self-care Behaviors Scale with Arteriovenous Fistula in Hemodialysis patients (ASBHD-AVF). The secondary outcome will be assessed using the Hemodialysis Access-related Quality of Life (HARQ) which is a self-administered tool develop by Nordyke.\n\nThe primary and secondary outcomes will be assessed at: baseline, after the completion of the intervention, and follow-up data will be collected at the second and sixth weeks after intervention is completed. Data will be analyzed using the Statistical Package of Social Science (SPSS) version 25. Descriptive statistics, means and standard deviations will be used for the continuous variables, while frequencies and percentages will be utilized for categorical demographic data (gender, educational level, hemodialysis frequency, items of self-care behavior scale, QOL). Normality of data will be check and applied test accordingly.",[113,61,27],[164,165,166,167,168],"Slef-care behaviors","hemodialysis","quality of life","arteriovenous fistula","Kidney disease","2025-04-20",{"date":171,"type":34},"2025-04-27",{"date":173,"type":21},"2025-05-01",{"date":175,"type":21},"2025-08-30",{"name":177,"class":82},"Shifa Tameer-e-Millat University",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":83},"100486280","acoustic-analysis-of-va-sounds-100486280","NCT05612022","Acoustic Analysis of VA Sounds","Acoustic Analysis of Blood Flow-emitted Sounds to Detect Vascular Complications in Arteriovenous Fistulae and Grafts for Hemodialysis","VAsound","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures.\n2. Patients in HD treatment that need a new VA or patients that entered the pre-dialysis program because of ESRD. In all these cases the treatment of first choice should be the creation of a distal autogenous AVF, the creation of an AVG or the proximalization of an occluded VA.\n\nExclusion Criteria:\n\n1. Contraindications for the creation of an autogenous AVF, for the AVG creation or the proximalization of a failed VA.\n2. Patients who use catheter to perform HD.\n3. Patients undergoing peritoneal dialysis.\n4. Patients with life expectancy less than 2 years.","90 Years",{"count":188,"type":21},44,"End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. A successful HD procedure requires a functioning vascular access (VA) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. The current recommendation for VA is the native arteriovenous fistula (AVF), surgically created in the forearm by an anastomosis between a vein and an artery. The AVF, despite being the first-choice treatment, is still affected by high non-maturation and early failure rates, requiring in most of the cases, the creation of a new VA. An arteriovenous graft (AVG) is the second choice for a VA. Surgery is done using an artificial plastic tube that connects an artery to a vein. The AVG matures earlier than AVF (2\u002F3 vs 6 weeks), but it is more prone to infections and has lower survival.\n\nIt would be important to identify patients at risk of VA failure, but there is currently a lack of adequate strategies for surveillance. A continuous monitoring of the VA function would help in identification of reduced blood flow and VA stenosis, that could be treated by interventional radiologists before AVF or AVG complete closure. Over the years, nurses and nephrologists got used to touch the VA and qualitatively evaluate its vibration, named \"thrill\", and the sounds emitted by the same using their stethoscope.\n\nThe purpose of this study is to assess the feasibility of VA sound recording and analysis and provide preliminary evidence of VA sound clinical validity and utility to assess, monitor and predict vascular remodelling occurring in AVFs and AVGs.\n\nThis is a single center prospective observational study involving the acquisition of VA sounds and Doppler US examinations in consenting patients with ESRD.\n\nTo reach this goal, two groups of ESRD patients in need of VA surgery to perform HD treatment will be involved:\n\nGroup 1. Patients with AVF as first line HD access option.\n\nGroup 2. Patients with AVG as first line HD access option.",[26,27],[114,192,193,194,195,196],"AVG","VA sounds","acoustic analysis","VA remodelling","Doppler Ultrasound","2024-11-26",{"date":199,"type":34},"2024-11-29",{"date":201,"type":34},"2023-05-09",{"date":203,"type":21},"2026-12",{"name":205,"class":82},"Mario Negri Institute for Pharmacological Research",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":214,"targetDuration":216,"studyType":23,"phases":4,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100556658","drug-coated-balloon-compared-with-cutting-balloon-in-treatment-of-arteriovenous-fistula-stenosis-100556658","NCT06527963","DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis","Dragon","Inclusion Criteria:\n\nSubjects aged between 18 and 75 years. Subjects possess a mature upper limb autologous arteriovenous fistula (AVF) and have undergone at least one hemodialysis session.\n\nTarget lesion must be located in the venous segment of the upper limb AVF. Doppler ultrasound confirms that the target lesion stenosis is ≥50%, accompanied by at least one of the following clinical manifestations: elevated venous pressure during dialysis, abnormal fistula signs, significant reduction in blood flow (\\\u003C200ml\u002Fmin).\n\nGuidewire and balloon successfully pass through the lesion and complete dilation. 6.Subjects or their legal representatives must understand the purpose of the trial, voluntarily participate in the clinical trial, and sign an informed consent form, while also being willing to adhere to the specific follow-up schedules set by this trial.\n\nExclusion Criteria:\n\nTarget lesion located in the arterial segment or anastomosis of the AVF. Target lesion located in the lower limb AVF. Subjects with previous stent implantation in the AVF. Patients diagnosed with symptomatic central venous occlusive disease: AVF flow reduction accompanied by swelling of the ipsilateral limb, chest, or facial area, with DSA confirmation of central venous occlusive disease.\n\nSubjects with two or more target lesions in the AVF (when two stenoses are less than 3 cm apart, they are considered as one target lesion).\n\nSubjects with acute thrombosis in the AVF or who have undergone AVF thrombolysis or thrombectomy within the past 30 days.\n\nSubjects who have undergone or plan to undergo surgical intervention on the AVF within 30 days.\n\nSubjects with AVF infection or concurrent systemic active infection. Subjects planning renal transplantation or switching to peritoneal dialysis within the next 12 months.\n\nSubjects with diseases causing coagulopathy, such as thrombocytopenic purpura. Subjects undergoing immunotherapy or suspected\u002Fdiagnosed with vasculitis. Subjects with allergies or contraindications to heparin or contrast agents. Subjects who are pregnant or breastfeeding. Subjects with a life expectancy of less than 12 months.","75 Years",{"count":215,"type":21},180,"12 Months","The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are:\n\n1. Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons?\n2. What medical problems do participants have when receiving treatment with drug-coated balloons or cutting balloons?",[98,219,27],"Angioplasty, Balloon","2024-07-25",{"date":222,"type":34},"2024-07-30",{"date":224,"type":34},"2024-07-01",{"date":226,"type":21},"2026-12-31",{"name":228,"class":82},"RenJi Hospital",3,{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":246,"locationsCount":229},"100553992","effectiveness-of-endoluminal-treatment-of-autologous-arteriovenous-endovascular-fistula-failure-100553992","NCT06493292","Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure","Comparison of the Efficacy of Drug-Coated Balloons and Cutting Balloons in the Treatment of Autologous Arteriovenous Fistula Stenosis: A Multi-Center Prospective Real-World Study.","Inclusion Criteria:\n\n1. Subjects aged between 18 and 75 years.\n2. Subjects possess a mature upper limb autologous arteriovenous fistula (AVF) and have undergone at least one hemodialysis session.\n3. Target lesion must be located in the venous segment of the upper limb AVF.\n4. Doppler ultrasound confirms that the target lesion stenosis is ≥50%, accompanied by at least one of the following clinical manifestations: elevated venous pressure during dialysis, abnormal fistula signs, significant reduction in blood flow (\\\u003C200ml\u002Fmin).\n5. Guidewire and balloon successfully pass through the lesion and complete dilation. 6.Subjects or their legal representatives must understand the purpose of the trial, voluntarily participate in the clinical trial, and sign an informed consent form, while also being willing to adhere to the specific follow-up schedules set by this trial.\n\nExclusion Criteria:\n\n1. Target lesion located in the arterial segment or anastomosis of the AVF.\n2. Target lesion located in the lower limb AVF.\n3. Subjects with previous stent implantation in the AVF.\n4. Patients diagnosed with symptomatic central venous occlusive disease: AVF flow reduction accompanied by swelling of the ipsilateral limb, chest, or facial area, with DSA confirmation of central venous occlusive disease.\n5. Subjects with two or more target lesions in the AVF (when two stenoses are less than 3 cm apart, they are considered as one target lesion).\n6. Subjects with acute thrombosis in the AVF or who have undergone AVF thrombolysis or thrombectomy within the past 30 days.\n7. Subjects who have undergone or plan to undergo surgical intervention on the AVF within 30 days.\n8. Subjects with AVF infection or concurrent systemic active infection.\n9. Subjects planning renal transplantation or switching to peritoneal dialysis within the next 12 months.\n10. Subjects with diseases causing coagulopathy, such as thrombocytopenic purpura.\n11. Subjects undergoing immunotherapy or suspected\u002Fdiagnosed with vasculitis.\n12. Subjects with allergies or contraindications to heparin or contrast agents.\n13. Subjects who are pregnant or breastfeeding.\n14. Subjects with a life expectancy of less than 12 months.",{"count":215,"type":21},"This study was aimed at comparing the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous segment stenosis of autologous arteriovenous fistulas.This is a prospective, multi-center cohort study.",[27],"2024-07-02",{"date":242,"type":34},"2024-07-09",{"date":244,"type":34},"2024-06-01",{"date":203,"type":21},{"name":228,"class":82},{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":254,"enrollmentInfo":255,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":265,"locationsCount":83},"100552250","effectiveness-and-health-economics-of-endoluminal-treatment-of-arteriovenous-graft-fistula-100552250","NCT06470646","Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.","A Real-World Clinical Study Based on Decentralized Arteriovenous Fistula Data System - Endovascular Treatment Efficacy and Health Economics Evaluation of Failure in Arteriovenous Graft Fistula.","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years undergoing hemodialysis;\n2. Patients with arteriovenous graft fistula unable to complete hemodialysis;\n3. The guidewire must pass through the stenosis of the lesion side's graft fistula and further undergo endovascular treatment to be eligible for inclusion. This study does not limit the form of guidewire passing through the target lesion;\n4. Patients who have successfully undergone endovascular treatment again after the initial target lesion opening failure are still eligible for inclusion;\n5. Subjects and their legal representatives understand the purpose of the study, voluntarily participate, and sign informed consent forms, willing to undergo follow-up at specific time points in this trial.\n\nExclusion Criteria:\n\n1. Planned kidney transplant or conversion to peritoneal dialysis\n2. Women who are pregnant,breastfeeding or planning to become pregnant during the study period\n3. Recent (within 30 days) or planned surgical procedure for haemodialysis access\n4. Allergy or contraindication to heparin, contrast media, antiplatelet drugs\n5. Patients who have participated in a clinical trial of a drug or other medical device that interferes with this clinical trial within the last 3 months.\n6. Patients with a history of coagulation disorders or other haematological disorders\n7. Patients with other conditions that may make the trial difficult or significantly shorten the patient's life expectancy (\\\u003C2 years), e.g.tumours,severe liver disease,cardiac insufficiency,etc.,or patients with a life expectancy of less than 6 months.\n8. Patients unable or unwilling to participate in this trial","80 Years",{"count":256,"type":21},240,"This study is a prospective, single-center real-world research, aiming to understand the clinical intervention effects and health economics value of various endovascular treatment methods for arteriovenous graft fistula failure in the real world. The target lesion is defined as the inflow tract (artery, anastomosis, bend), middle segment, and outflow vein of the dialysis pathway. The study will recruit 240 patients with arteriovenous graft fistula failure at a single center from September 2023 to December 2024. Depending on different treatment methods, patients will be divided into several subgroups, such as the simple balloon dilation group, drug balloon group, stent implantation group, etc. As this is a real-world study, the main observations will be the technical success rate of various endovascular treatment methods, major adverse events during the perioperative period, and the symptom-driven target lesion re-intervention rate, target vessel patency rate, and total hospital expenditure related to target lesions at 1, 6, 12, 18, and 24 months postoperatively.",[27],"2024-06-17",{"date":261,"type":34},"2024-06-24",{"date":263,"type":34},"2023-09-01",{"date":226,"type":21},{"name":228,"class":82},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":254,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":283,"locationsCount":83},"100551000","effectiveness-and-health-economics-of-endoluminal-treatment-of-autologous-arteriovenous-endovascular-fistula-failure-100551000","NCT06454396","Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure","A Real-world Clinical Study Based on a Decentralized Arteriovenous Endovascular Fistula Data System - Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure","Inclusion Criteria:\n\n1. Hemodialysis patients over 18 years of age and under 80 years of age\n2. Autologous arteriovenous fistula cannot be used in patients completing haemodialysis\n3. The guidewire must pass through at least the stenosis of the endovascular fistula on the side of the lesion and undergo further endovascular treatment before enrolment, and this study does not limit the form of the guidewire passing through the target lesion.\n4. Patients who have failed to open the initial target lesion and are successful on a second attempt at endoluminal therapy may still be enrolled.\n5. Subjects and their legal representatives are able to understand the purpose of the study, participate voluntarily and sign an informed consent form, and are willing to be followed up at specific points in time.\n\nExclusion Criteria:\n\n1. Planned kidney transplant or conversion to peritoneal dialysis\n2. Women who are pregnant, breastfeeding or planning to become pregnant during the study period\n3. Recent (within 30 days) or planned surgical procedure for haemodialysis access\n4. Allergy or contraindication to heparin, contrast media, antiplatelet drugs\n5. Patients who have participated in a clinical trial of a drug or other medical device that interferes with this clinical trial within the last 3 months.\n6. Patients with a history of coagulation disorders or other haematological disorders\n7. Patients with other conditions that may make the trial difficult or significantly shorten the patient's life expectancy (\\\u003C2 years), e.g. tumours, severe liver disease, cardiac insufficiency, etc., or patients with a life expectancy of less than 6 months.\n8. Patients unable or unwilling to participate in this trial",{"count":274,"type":21},480,"This study was aimed at evaluating the efficacy of different endovascular treatments for early and mid-stage clinical interventions in patients with autologous arteriovenous fistulae loss of function and the corresponding health economic value.",[27],"2024-06-06",{"date":279,"type":34},"2024-06-12",{"date":281,"type":34},"2023-01-01",{"date":226,"type":21},{"name":228,"class":82},{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":53,"phases":293,"briefSummary":294,"conditions":295,"keywords":296,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":304,"leadSponsor":306,"locationsCount":83},"100446667","three-dimensional-3d-printed-hemodialysis-vascular-model-100446667","NCT05096416","Three-dimensional (3D) Printed Hemodialysis Vascular Model","Three-dimensional (3D) Printed Hemodialysis Vascular Model for Increased Precision of Cannulation","Inclusion Criteria:\n\n* Patients with a surgically placed hemodialysis access which has been used in the last 90 days or is being prepared for use in the next 90 days\n\nExclusion Criteria:\n\n* Patients with only failed hemodialysis surgical access(es) that has\u002Fhave not been used for \\>90 days.",{"count":292,"type":21},20,[94],"Infiltration of a surgically-placed hemodialysis vascular access (HVA) is recognized as a major contributor to the high hospital re-admission rate in dialysis-dependent patients. Three dimensional modeling has been demonstrated as a critical tool for procedurists in preparation for surgical interventions but no such modeling is yet available for dialysis specialists to avoid the common complication of HVA infiltration. Contrast enhanced magnetic resonance angiography (MRA) can be used to generate a three dimensional image data that could render a three dimensional resin-based model of a vascular access.",[27],[165,297,298,299],"Magnetic resonance angiography","three-dimensional (3D) printed hemodialysis vascular model","Vascular access complication","2022-07-31",{"date":302,"type":34},"2022-08-02",{"date":281,"type":21},{"date":305,"type":21},"2026-07-31",{"name":307,"class":82},"Brigham and Women's Hospital"]