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

NCT ID: NCT04988789

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Dialysis Access Malfunction Kidney Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Paclitaxel Drug Coated Balloon

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tang Tjun Yip

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

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Singapore General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Charyl Yap

Role: CONTACT

6576 7986

Facility Contacts

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Charyl Yap

Role: primary

Other Identifiers

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2020/2320

Identifier Type: -

Identifier Source: org_study_id

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