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

• Conditions: Dialysis Access Malfunction; Kidney Failure

• Registration Number: NCT04988789
• Lead Sponsor: Singapore General Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-25
• Study First Submitted QC: 2021-07-25
• Last Update Submitted: 2021-07-25
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Patency	12 months	Secondary Patency is lost when entire dialysis access circuit is abandoned.
Circuit Access Patency	12 Months	Circuit Access Patency is lost when AVF/AVG is intervened on
Primary Assisted Patency	12 months	Primary Assisted Patency is lost when circuit undergoes thrombectromy/thrombolysis

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore