Actively Recruiting
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Led by Singapore General Hospital · Updated on 2024-08-14
94
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Singapore General Hospital
Lead Sponsor
S
Singapore Clinical Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness of two types of balloon angioplasty treatments for patients with narrowing (stenosis) in their arteriovenous fistula (AVF), which is used for dialysis access. The study focuses on the primary patency, meaning how long the access remains open without further narrowing, after treatment using either a drug-coated balloon (Ranger) or a conventional balloon. This trial is a blinded, randomized controlled study involving patients with AVF stenosis. Participants will be randomly assigned in equal numbers to receive angioplasty with either the Ranger drug-coated balloon or a conventional balloon. All peripheral AVF narrowings will be treated using the assigned balloon type. The study includes a primary outcome measure of access circuit primary patency assessed at 6 months, with additional secondary outcomes measured at 6, 12 months, and longer term. During the study, patients will be monitored for how well their dialysis access remains open, any complications from the procedure, and overall mortality up to 5 years. The study involves follow-up assessments to evaluate the success of the angioplasty treatments and the condition of the AVF over time. Participants are expected to be adults aged 21 or older who meet specific criteria related to their AVF condition and treatment suitability.
CONDITIONS
Brief Title
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Failing arteriovenous fistula (AVF) with at least one stenosis causing clinical, physiological, or haemodynamic abnormalities, including new or recurrent stenosis.
- AVF used successfully for at least one month (non-mature AVF not allowed).
- Less than 30% residual stenosis after angioplasty.
- Age 21 years or older.
- Informed and valid consent provided.
You will not qualify if you...
- Thrombosed AVFs.
- Haemodynamically significant central vein stenosis.
- Target lesion not treatable with available drug-coated balloon sizes (up to 8mm).
- Contraindication to antiplatelet therapy.
- Coagulopathy or thrombocytopenia not manageable with periprocedural transfusion.
- Allergy or contraindication to paclitaxel.
- Acute infection at the puncture site.
- Women who are breastfeeding, pregnant, or planning pregnancy during the study.
- Medical conditions that may cause noncompliance with the protocol.
- Participation in another investigational drug, biologic, or device trial impacting dialysis access or previous enrolment in this study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with follow-up period
Participants undergo angioplasty of all peripheral arteriovenous fistula (AVF) stenoses using either a drug-coated balloon or a conventional balloon depending on their allocation.
1 baseline visit (procedure) and regular follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Singapore General Hospital
Singapore, Singapore
Actively Recruiting
Research Team
A
Arjunana Sarupraba
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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