NCT04988789

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

3.8 years

First QC Date

July 25, 2021

Last Update Submit

July 25, 2021

Conditions

Dialysis Access MalfunctionKidney Failure

Outcome Measures

Primary Outcomes (3)

  • Circuit Access Patency

    Circuit Access Patency is lost when AVF/AVG is intervened on

    12 Months

  • Primary Assisted Patency

    Primary Assisted Patency is lost when circuit undergoes thrombectromy/thrombolysis

    12 months

  • Secondary Patency

    Secondary Patency is lost when entire dialysis access circuit is abandoned.

    12 months

Interventions

Paclitaxel Drug Coated BalloonDRUG

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

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • All patients below 21

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Tang Tjun Yip

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charyl Yap

CONTACT

6576 7986Charyl.yap.j.q@sgh.com.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2021

First Posted

August 4, 2021

Study Start

April 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 4, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)