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

Not Applicable

Terminated

• Conditions: Arteriovenous Fistula; Fistula
• Interventions: Procedure: Cutting balloon angioplasty; Procedure: Angioplasty

• Registration Number: NCT01321866
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Study Start: 2012-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Cutting balloon angioplasty	Patients in this arm will have angioplasty of a fistula stenosis using a cutting balloon
Standard arm	Angioplasty	Patients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon.

Primary Outcome Measures

Name	Time	Method
Primary patency	12 months	Primary patency following a first angioplasty of a first stenose in the affected zone.

Secondary Outcome Measures

Name	Time	Method
Presence/absence of complications associated with the angioplasty	Day of intervention
Questionnaire KDQOL	6 months
Direct medical costs (€)	12 months
Questionnaire SF36	6 months
% Stenosis	3 months	100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))\*100)
Number of early re-stenoses	3 months	stenosis defined as lumen diameter \< 2mm
Number of re-stenoses	12 months	Stenosis defined as lumen diameter \< 2mm
Number of stents used	12 months	The total number of stents placed between the study angioplasty and the end-of-study visit.
Total number of venous thromboses	12 months	Total number of venous thromboses between study angioplasty and end-of-study visit
Fistula quality (cm*ml/min)	12 months	cumulative length of "usable" fistula (cm) \* venous flow during the last hemodialysis (ml/min)
Total days in hospital	12 months	The total number of days hospitalized for stenosis, thrombosis, or recovering vascular access. This does not include regular hemodialysis activities.
Indirect costs (€)	12 months
Presence/absence of complications since the last visit	12 months

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes Cedex 09, Gard, France