To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty
This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (Ranger) or conventional balloon. All peripheral AVF stenoses will be treated with the allocated balloon type. The primary outcome measure is 6-month access circuit patency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
94
All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation
Singapore General Hospital
Singapore, Singapore
RECRUITINGAccess circuit primary patency
Time to next clinically-driven intervention
Time frame: 6 months
Access access circuit patency
Time to next clinically-driven intervention
Time frame: 12 months
Access circuit assisted primary patency
Time to next access thrombosis or surgical intervention.
Time frame: 6 and 12 months
Access circuit secondary patency
Time to access abandonment or surgical revision / declotting
Time frame: 6 and 12 months
Procedural complication
Complication related to procedure
Time frame: 12 months
Mortality
All cause mortality
Time frame: 12 months and 5 years
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