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Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction

Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04988789
Enrollment
500
Registered
2021-08-04
Start date
2020-04-01
Completion date
2023-12-31
Last updated
2021-08-04

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

Conditions

Dialysis Access Malfunction, Kidney Failure

Brief summary

Recent studies of paclitaxel DCB in the treatment of stenosis at dialysis vascular access have shown promising results. Paclitaxel, an anti-proliferation drug, is released during balloon inflation and potentially improve primary patency by slowing down NIH effect. However, meta-analysis have suggested that the use of paclitaxel in lower limbs have increased risk of death in patients. The effect of paclitaxel DCB on dialysis access however remains unknown. Hence, we aim to set up a database to track long-term treatment outcomes of patients treated with Paclitaxel DCB at SGH for their stenosed dialysis access

Interventions

Failing AVF/AVGs treated with Paclitaxel Drug Coated balloons are captured in this database

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years

Inclusion criteria

* All patients above 21 that is undergoing AVF/AVG fistuloplasty with paclitaxel DCB at SGH is included

Exclusion criteria

* All patients below 21

Design outcomes

Primary

MeasureTime frameDescription
Circuit Access Patency12 MonthsCircuit Access Patency is lost when AVF/AVG is intervened on
Primary Assisted Patency12 monthsPrimary Assisted Patency is lost when circuit undergoes thrombectromy/thrombolysis
Secondary Patency12 monthsSecondary Patency is lost when entire dialysis access circuit is abandoned.

Countries

Singapore

Contacts

Primary ContactCharyl Yap
Charyl.yap.j.q@sgh.com.sg6576 7986

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026