Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients

Randomized Trial Comparing a Cutting Balloon to a Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients

The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.

Inclusion Criteria:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 12 months of follow-up
• The patient is on hemodialysis because of chronic renal insufficiency
• The patient's vascular access is an arterio-venous fistula
• The patient has a venous stenosis in the fistula (first event in the studied zone)
• The patient is scheduled for angioplasty

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient cannot fluently read French
• The patient cannot understand French
• The patient is pregnant
• The patient is breastfeeding
• Short term dialysis
• The vascular access is a "graft"
• The stenosis in question is a recurrence, and not a first event in the studied zone
• The life expectancy of the patient is < 12 months
• Medical emergency situation
• Peritoneal dialysis
• At-home dialysis