Renal Insufficiency Clinical Trial
Official title:
Prospective, Randomized Trial on the Clinical Utility of Drug-coated Balloons After Angioplasty of Plain Old Balloon-resistent Dialysis Fistula Stenosis Using Cutting Ballons
The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1
year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts
62-87%), necessitating a therapeutic measure to preserve dialysis access during this period
in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a
standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success
rate of 50-79% [2-4].In turn, in 21-50% of the cases an insufficient PTA result is obtained
(so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting
balloon (carrying with small knives on its surface) is performed, leading to a success rate
of 89%. However, a problem is the high incidence of restenosis, which is about 40% for
recurrent stenosis and over 10% in de novo stenosis.
The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in
the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is
unknown.
Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of
a cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses
compared to the sole use of a cutting balloon.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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