Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

Drug Eluting Versus Conventional Balloon Angioplasty for the Treatment of Failing Dialysis Access. A Prospective Randomized Single-Center Trial.

The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.

In total 40 patients already diagnosed with hemodynamically significant stenosis of the dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous transluminal angioplasty by our department, will sign informed consent and will be randomized to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The protocol includes the description of patient's demographics (age, gender,dialysis access details, risk factors) and procedural details, as well as immediate results and long-term follow up.

Inclusion Criteria:

• Angiographic and clinical diagnosis of dysfunctional dialysis access due to one or more stenotic lesions.
• Patients with AVF or AVG
• Fistula or graft or vessel diameter ranging from 3 mm up to 12 mm

Exclusion Criteria:

• Fistula or graft or vessel diameter < 3 mm and > 12 mm
• History of severe allergic reaction to contrast media
• Intolerance to aspirin and/or clopidogrel
• Systemic coagulopathy or hypercoagulation disorders