Stenosis of Arteriovenous Dialysis Fistula Clinical Trial
Official title:
Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients.
This is a single-centre study, where a total of 124 subjects with non-maturing arteriovenous
fistula will be randomised (1:1) to either experimental or active comparator arm.
Randomisation will be stratified by location of arteriovenous fistula (above versus below
elbow).
Each subject will undergo fistulogram in order to assess eligibility criteria. In the event
that there is more than 1 eligible stenosis, the most severe stenosis will be considered the
target (study) lesion. All other lesions will be treated in the conventional manner. No coil
embolisation of collaterals will be performed in the index treatment.
If the subject is allocated to the experimental arm, the target lesion will be treated with
pre-dilatation with a conventional balloon before application of the drug-eluting ballon.
If the subject is allocated to the active comparator arm, the target lesion will be treated
with a conventional balloon.
High pressure balloon angioplasty may be performed if there is poor angioplasty results
(significant residual stenosis of more than 30%).
All subjects will be prescribed 1 month of dual antiplatelets (aspirin and clopidogrel),
followed by 5 months of aspirin.
The duration of the study is 12 months. Follow up visits include:
1. Two-weekly follow up visits in the first 3 months after intervention until the patient
is deemed ready for trial cannulation.
2. At 3 months after intervention to assess primary outcome.
3. At 6 months after intervention for a fistulogram
4. At 12 months after intervention for study closure.
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