Stenosis of Arteriovenous Dialysis Fistula Clinical Trial
Official title:
Prospective Randomized Trial Comparing Drug Eluting Balloon Angioplasty Versus Conventional Percutaneous Transluminal Angioplasty Balloon for the Treatment of Hemodialysis Arterio-Venous Fistula or Arterio-Venous Graft Stenoses
A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty versus conventional percutaneous transluminal angioplasty balloon for the treatment of hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late luminal loss and restenosis rates, while prolonging primary and secondary patencies.
Introduction:
Neointimal hyperplasia is the main cause of hemodialysis access [arterio-venous fistula (AVF)
or graft (AVG)] dysfunction and thrombosis. Although endovascular techniques like
percutaneous transluminal angioplasty (PTA), catheter directed thrombolysis, mechanical
thrombectomy or bare metal stenting, may salvage the access, long term patency remains dismal
due to recurrent stenosis from neointimal hyperplasia.
Drug Eluting Balloon (DEB) is effective in inhibiting neointimal hyperplasia for treatment of
coronary in-stent restenosis since 2006 and more recently in femoropopliteal arteries,
reducing restenosis rates and prolonging patency.
Specific Aim:
To determine the efficacy of DEB in reducing restenosis rates and prolonging the patency of
AVFs/AVGs compared to PTA.
Hypothesis:
DEB is superior to PTA in reducing late luminal loss and restenosis rates, while prolonging
primary and secondary patencies.
Methodology:
Prospective, randomized clinical trial with study population comprising of patients with
dysfunctional AVFs/AVGs due to underlying stenoses. The patients will be randomized to
receive either DEB or PTA.
The 6-month late luminal loss will be primary endpoint. The secondary endpoints of restenosis
rate, primary and secondary patencies, will also be determined.
Major Clinical Significance:
Hemodialysis access failures constitute significant morbidity and costs to patient and
healthcare system. Maintaining access patency consumes significant resources and constitutes
a significant portion of the work of vascular surgeons, nephrologists and interventional
radiologists.
Any strategy that reduces access failure or prolonging access lifespan will be beneficial. If
DEB is proven to be superior to PTA, there will be a paradigm shift in management of
hemodialysis access failures from restenosis - similar to how DEB has changed practice in
managing coronary artery in-stent restenosis.
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