Status:
UNKNOWN
Sirolimus Coated Angioplasty Versus Plain Balloon Angioplasty
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
National University Hospital, Singapore
Sengkang General Hospital
Conditions:
End Stage Renal Failure on Dialysis
Arteriovenous Graft Occlusion
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
A functioning dialysis access is critical to the delivery of hemodialysis therapy in patients with End Stage Renal Disease. Stenosis secondary to neo-intimal hyperplasia frequently occur within the di...
Detailed Description
Dialysis vascular accesses such as Arteriovenous Fistula (AVF) and Arteriovenous Grafts (AVG) are surgically created vasculatures used for hemodialysis in patients with End-Stage Renal Disease (ESRD)....
Eligibility Criteria
Inclusion
- Age 21 to 85 years
- Patient who requires balloon angioplasty for dysfunction arteriovenous fistula
- Matured AVF, defined as being in use for at least 1 month prior to angioplasty
- 4\. Successful 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 if no treatment is required.)
Exclusion
- Patient unable to provide informed consent
- Thrombosed or partially thrombosed AVF
- 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
- Patient who are currently enrolled in other drug eluting balloon trials
- Sepsis or active infection
- Recent intracranial bleed or gastrointestinal bleed within the past 12 months
- Allergy to iodinated contrast media, anti-platelet drugs, heparin or sirolimus
- Pregnancy
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04409912
Start Date
January 11 2021
End Date
October 1 2024
Last Update
August 6 2021
Active Locations (3)
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1
National University Hospital
Singapore, Singapore, 119074
2
Singapore General Hospital
Singapore, Singapore, 169608
3
Sengkang General Hospital
Singapore, Singapore, 544886