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

July 25, 2021 updated by: Singapore General Hospital
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Investigators

  • Principal Investigator: Tang Tjun Yip, Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 25, 2021

First Submitted That Met QC Criteria

July 25, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 25, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/2320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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