Venous Anastomosis Stenosis of Dysfunctional Hemodialysis Access Grafts Venous Anastomotic Stenosis ,Hemodialysis Access Grafts ,Covered Stent
Conditions
Interventions
After placing a 6Fr sheath and crossing the lesion with a wire, the stenotic lesion at the venous anastomosis is pre-dilated with a high-pressure balloon. A Covera vascular covered stent, typically 8
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Vascular Covered Stent,High-Pressure Balloon Angioplasty
Sponsors
Faculty of Medicine Ramathibodi Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients on hemodialysis using a forearm or upper arm arterio-venous graft who are diagnosed with venous anastomosis stenosis or occlusion. 2.Patients must have graft dysfunction, defined by National Kidney Foundation KDOQI guidelines (e.g., blood flow reduction, increased venous pressure, prolonged bleeding time, etc.). 3.The AV graft must have been placed more than 30 days prior and has been used at least once. 4.The length of the stenotic lesion must be less than or equal to 9 cm. 5.The diameter of the non-stenotic outflow vein is between 5-9 cm. 6.The patient provides informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Patient is unable to attend scheduled follow-up appointments. 2.Patient refuses to participate or withdraws from the study. 3.Presence of infection at the AV graft site. 4.Presence of central venous stenosis or occlusion. 5.The AV graft is located in the leg. 6.Patient has uncorrectable coagulopathy. 7.Patient has a known allergy to nickel or titanium.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Primary Patency 2 weeks, 3 months, 6 months, and 1 year post-procedure Clinically-driven reintervention or access abandonment, confirmed by Duplex Ultrasound or Angiography | — |
Secondary
| Measure | Time frame |
|---|---|
| Access Circuit Primary Patency 2 weeks, 3 months, 6 months, and 1 year post-procedure Freedom from repeat intervention in the access circuit or access circuit thrombosis, confirmed by clinical assessment and imaging,Postoperative Complications Within 30 days post-procedure Incidence of adverse events (e.g., access site complication, infection, allergic reaction, bleeding, thrombosis),Number of Reinterventions 2 weeks, 3 months, 6 months, and 1 year post-procedure Count of clinically-driven reintervention procedures required | — |
Countries
Thailand
Contacts
Public ContactTin Artavatkun
Faculty of Medicine Ramathibodi Hospital
Outcome results
None listed