Status:
UNKNOWN
A Real-world Registry Investigating Sirolimus-coated Balloon Versus Paclitaxel-coated Balloon Angioplasty for the Treatment of Dysfunctional Arteriovenous Fistula
Lead Sponsor:
Singapore General Hospital
Conditions:
Dialysis Access Malfunction
Stenosis
Eligibility:
All Genders
21-85 years
Brief Summary
Drug-coated balloon (DCB) angioplasty has been shown to be superior to POBA in the treatment of stenosis in AVF. This is because the very intervention used to treat underlying stenosis by POBA can ind...
Eligibility Criteria
Inclusion
- Age 21-85 years
- Patient who required balloon angioplasty for dysfunctional or thrombosed AVF
- Successful thrombolysis and angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA) based on visual assessment of the operator and restoration of thrill in the AVF on clinical examination. For concurrent asymptomatic or angiographically not significant central vein stenosis, patients can be included in no treatment is required.
- received either PDCB or SDCB for the treatment of stenosis.
Exclusion
- Patient unable to provide informed consent
- Presence of symptomatic or angiographically significant central vein stenosis who require treatment, with more than 30% residual stenosis post angioplasty
- Patients who had underwent stent placement within the AVF circuit
- Sepsis or active infection
- Recent intracranial bleed or gastrointestinal bleed within the past 12 months.
- Allergy to iodinated contrast media, heparin, paclitaxel or sirolimus
- Pregnancy
- Inadequate treatment of underlying stenosis, defined as \>= 30% residual stenosis of the underlying lesions.
Key Trial Info
Start Date :
April 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05333640
Start Date
April 18 2022
End Date
April 30 2024
Last Update
April 19 2022
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169856