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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04988789
Other study ID # 2020/2320
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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