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

Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04988789
• Other study ID #: 2020/2320
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2021
• Source: Singapore General Hospital
• Contact: Charyl Yap
• Phone: 6576 7986
• Email: Charyl.yap.j.q[@]sgh.com.sg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Dialysis Access Malfunction
• Kidney Failure
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circuit Access Patency	Circuit Access Patency is lost when AVF/AVG is intervened on	12 Months
Primary	Primary Assisted Patency	Primary Assisted Patency is lost when circuit undergoes thrombectromy/thrombolysis	12 months
Primary	Secondary Patency	Secondary Patency is lost when entire dialysis access circuit is abandoned.	12 months