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

Centre Hospitalier Universitaire de Nīmes42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Arteriovenous Fistula Fistula

Interventions

Cutting balloon angioplastyPROCEDURE

Angioplasty of fistula stenosis using a cutting balloon

AngioplastyPROCEDURE

Angioplasty of fistula stenosis using a non-cutting balloon

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Outcomes

Primary Outcomes

Primary patency

Primary patency following a first angioplasty of a first stenose in the affected zone.

Time frame: 12 months

Secondary Outcomes

Number of early re-stenoses

stenosis defined as lumen diameter \< 2mm

Time frame: 3 months

Number of re-stenoses

Stenosis defined as lumen diameter \< 2mm

Time frame: 12 months

Total days in hospital

The total number of days hospitalized for stenosis, thrombosis, or recovering vascular access. This does not include regular hemodialysis activities.

Time frame: 12 months

Number of stents used

The total number of stents placed between the study angioplasty and the end-of-study visit.

Time frame: 12 months

Total number of venous thromboses

Total number of venous thromboses between study angioplasty and end-of-study visit

Time frame: 12 months

Direct medical costs (€)

Time frame: 12 months

Indirect costs (€)

Time frame: 12 months

Questionnaire KDQOL

Time frame: 12 months

Questionnaire SF36

Data from ClinicalTrials.gov

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