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
312 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
To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty
CONDITIONS
Official 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 with at least one stenosis causing clinical, physiological, or hemodynamic abnormalities; both new and recurrent stenosis accepted
- Arteriovenous fistula 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 given
You will not qualify if you...
- Thrombosed arteriovenous fistulas
- Hemodynamically significant central vein stenosis
- Target lesion not treatable with available drug-eluting balloon sizes (up to 8mm)
- Contraindication to antiplatelet therapy
- Coagulopathy or thrombocytopenia not manageable with periprocedural transfusion
- Allergy or contraindication to paclitaxel
- Acute infection over proposed puncture site
- Women who are breastfeeding, pregnant, or planning pregnancy during the study
- Medical conditions that may cause noncompliance with the protocol
- Current participation in another investigational drug, biologic, or device trial affecting dialysis access or prior enrollment in this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Singapore General Hospital
Singapore, Singapore
Actively Recruiting
Research Team
A
Arjunana Sarupraba
CONTACT
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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