None listed
Conditions
Interventions
Medical Device : To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis graft, we would like to perform randomized study comparing the results of drug- coated balloon
s standard of care. no required any test on this study.
Sponsors
Soon Chun Hyang University Hospital Seoul
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age of more than 19, hemodialysis patients with AVG in their arms: Graft should be implanted 30 days ago before enrollment. 2. Vascular access actively used for hemodialysis: At least one hemodialysis successful session before enrollment. 3. Clinical signs of access dysfunction: decreased thrill, increased pulsatility, development collateral veins, limb swelling, difficulty in cannulation, prolonged bleeding after hemodialysis, high venous pressure or decreased hemodialysis flow rate during hemodialysis. 4. > 50% venous anastomotic stenosis of AVG, confirmed by fistulogram (angiography). 5. ?4cm from venous anastomosis site in lesion length 6. Reference diameter < 7mm of non-stenotic vessel or graft adjacent to venous stenosis. 7. Full expansion of conventional balloon during primary balloon angioplasty, confirmed by fluoroscopy.
Exclusion criteria
Exclusion criteria: 1. Patients unable to provide informed consent 2. Patient unable to abide with study follow-up protocol. 3. Patient participating in other relevant or conflicting studies 4. Bare metal stent or stent-graft placed previously 5. Hemodynamically significant stenosis of the central venous system 6. ?50% stenosis in arterial anastomotic site or venous outflow tract, non including venous anastomosis site 7. Stenosis with a corresponding thrombosis treated within 7 days before enrollment. 8. Limited life expectancy less than 6 months 9. Sepsis or active infection. 10. Recent arm thrombophlebitis (< 6months). 11. Allergy or other known contraindication to iodinated contrast media, heparin, or paclitaxel 12. Pregnancy or Nursing state.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Patency in the treated lesion at 6 months, Comparison of MACE and complications, between DCB and conventional Balloon angioplasty group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Target Circuit Revascularization (TCR) and Overall dialysis graft survival at 6 months, Comparison of technical success and clinical success between two groups. | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-Erk Goo
Soon Chun Hyang University Hospital Seoul
Outcome results
None listed