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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arteriovenous Fistula, Fistula

Intervention / Treatment
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* Procedure: Cutting balloon angioplasty
* Procedure: Angioplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>Patients in this arm will have angioplasty of a fistula stenosis using a cutting balloon | Procedure: Cutting balloon angioplasty<br>* Angioplasty of fistula stenosis using a cutting balloon<br>|
| Active Comparator: Standard arm<br>Patients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon. | Procedure: Angioplasty<br>* Angioplasty of fistula stenosis using a non-cutting balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | Primary patency following a first angioplasty of a first stenose in the affected zone. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of early re-stenoses | stenosis defined as lumen diameter < 2mm | 3 months | 
| Number of re-stenoses | Stenosis defined as lumen diameter < 2mm | 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. | 12 months | 
| Number of stents used | The total number of stents placed between the study angioplasty and the end-of-study visit. | 12 months | 
| Total number of venous thromboses | Total number of venous thromboses between study angioplasty and end-of-study visit | 12 months | 
| Direct medical costs (€) |  | 12 months | 
| Indirect costs (€) |  | 12 months | 
| Questionnaire KDQOL |  | 12 months | 
| Questionnaire SF36 |  | 12 months | 
| Questionnaire KDQOL |  | 3 months | 
| Questionnaire KDQOL |  | 6 months | 
| Questionnaire SF36 |  | 3 months | 
| Questionnaire SF36 |  | 6 months | 
| Fistula quality (cm*ml/min) | cumulative length of usable fistula (cm) * venous flow during the last hemodialysis (ml/min) | Baseline | 
| Fistula quality (cm*ml/min) | cumulative length of usable fistula (cm) * venous flow during the last hemodialysis (ml/min) | 6 months | 
| Fistula quality (cm*ml/min) | cumulative length of usable fistula (cm) * venous flow during the last hemodialysis (ml/min) | 12 months | 
| % Stenosis | 100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100) | Baseline | 
| % Stenosis | 100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100) | 6 months | 
| % Stenosis | 100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100) | 12 months | 
| Presence/absence of complications associated with the angioplasty |  | Day of intervention | 
| % Stenosis | 100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100) | 3 months | 
| Presence/absence of complications since the last visit |  | 6 months | 
| Presence/absence of complications since the last visit |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angioplasty, cutting balloon