DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
186
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
RECRUITINGPatency
Primary end point is a composite of one or more of : * \>50% stenosis of index lesion requiring re-intervention * Re-intervention of index lesion due to clinical indications without 50% re-stenosis * Fistula failure
Time frame: 12 months
Technical success
Defined as \<30% residual stenosis using only the study balloon to which the patient was randomised
Time frame: Time of baseline index intervention
Assisted technical success of balloon angioplasty
Defined as \<30% residual stenosis using adjunctive procedures in addition to study balloon
Time frame: At time of baseline index intervention
Successful use of fistula for dialysis
Defined as successful use of the fistula for dialysis using 2 needles on at least one occasion
Time frame: In the 12 months following baseline index intervention
Secondary patency of the access circuit
Time frame: In the 12 months following baseline index intervention
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