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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Fistula; Arteriovenous Fistula

Treatments: Procedure: Cutting balloon angioplasty; Procedure: Angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01321866

2011-A00332-39 (Other Identifier)

AOI/2010/EP-01

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Experimental arm

Experimental group

Description:

Patients in this arm will have angioplasty of a fistula stenosis using a cutting balloon

Treatment:

Procedure: Cutting balloon angioplasty

Standard arm

Active Comparator group

Description:

Patients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon.

Treatment:

Procedure: Angioplasty