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DRUG COATED BALLOON ANGIOPLASTY IN FAILING ARTERIOVENOUS GRAFTS IN END STAGE RENAL DISEASE

DRUG COATED BALLOON ANGIOPLASTY IN FAILING ARTERIOVENOUS GRAFTS IN END STAGE RENAL DISEASE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202011880135496
Enrollment
120
Registered
2020-11-12
Start date
2020-11-09
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Disease

Interventions

Plain Old Balloon Angioplasty POBA
Drug coated balloon DCB angioplasty

Sponsors

University of the Witwatersrand and PI Prof Deirdre Kruger
Lead Sponsor

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

MeasureTime frame
Primary patency of haemodialysis AVGs following POBA vs DCB (primary endpoint).

Secondary

MeasureTime 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

melmbk@gmail.com+27740212418

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026