DRUG COATED BALLOON ANGIOPLASTY IN FAILING ARTERIOVENOUS GRAFTS IN END STAGE RENAL DISEASE
Not Applicable
- Conditions
- Kidney Disease
- Registration Number
- PACTR202011880135496
- Lead Sponsor
- niversity of the Witwatersrand and PI Prof Deirdre Kruger
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
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
AV graft >18 months old.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary patency of haemodialysis AVGs following POBA vs DCB (primary endpoint). <br>
- Secondary Outcome Measures
Name Time Method 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).