Status:
UNKNOWN
A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
Lead Sponsor:
Singapore General Hospital
Conditions:
Neointimal Hyperplasia
Dialysis Access Malfunction
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
Arteriovenous Fistula (AVF) is a surgically created circuit used for hemodialysis in patient with End Stage Renal Disease (ESRD). A functioning dialysis vascular access is critical to the delivery of ...
Eligibility Criteria
Inclusion
- Age 21 - 90 years
- Patients who requires balloon angioplasty for dysfunctional arteriovenous fistula, can be de novo lesions or recurrent CAS stenosis within six months of interventions. Suitability will be determined with a baseline ultrasound assessment.
- Matured AVF, defined as being in use for at least 1 month prior to angioplasty
- Successful angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA).
Exclusion
- Patient unable to provide informed consent
- Thrombosed or partially thrombosed AVF
- Immature AVF
- Insignificant CAS defined as \<50% stenosis and no clinical indicator such as high V pressure.
- Presence of central vein stenosis with more than 30% residual stenosis post-angioplasty
- Patient who had underwent stent placement within the CAS previously
- Patients who are allergic to both aspirin or clopidogrel
- 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, heparin or paclitaxel
- Pregnancy
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05360394
Start Date
April 20 2022
End Date
April 1 2024
Last Update
May 4 2022
Active Locations (2)
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1
Flinders Medical Center
Adelaide, Australia, 5042
2
Singapore General Hospital
Singapore, Singapore, 169856