Kidney Disease
Conditions
Interventions
Plain Old Balloon Angioplasty POBA
Drug coated balloon DCB angioplasty
Sponsors
University of the Witwatersrand and PI Prof Deirdre Kruger
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All adult haemodialysis patients with dysfunctional AVGs (=50% stenosis) presenting to the Vascare Rooms located at two private hospitals will be invited to participate in this study. No prior AV graft intervention. AV graft >4 months old. This is to exclude any failed grafts in the initial period following access placement and maturation.
Exclusion criteria
Exclusion criteria: AV graft >18 months old.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency of haemodialysis AVGs following POBA vs DCB (primary endpoint). | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. To compare the % restenosis and/or primary assisted patency post-DCB angioplasty to post-POBA at 6 weeks (±1 week) (secondary endpoint). 3. To compare the % restenosis and/or primary assisted patency* post-DCB angioplasty to post-POBA at 6 months (180 days; ±30 days) (secondary endpoint). | — |
Countries
South Africa
Contacts
Public ContactMellisa Mabhikwa
Data capturer Study coordinator
Outcome results
None listed