Clinical trial NCT01321866: Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients
Official title: Randomized Trial Comparing a Cutting Balloon to a Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arteriovenous Fistula
Fistula
Keywords: Angioplasty
cutting balloon
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
Secondary outcomes:
measure: Number of early re-stenoses
timeFrame: 3 months
measure: Number of re-stenoses
timeFrame: 12 months
measure: Total days in hospital
timeFrame: 12 months
measure: Number of stents used
timeFrame: 12 months
measure: Total number of venous thromboses
timeFrame: 12 months
measure: Direct medical costs (€)
timeFrame: 12 months
measure: Indirect costs (€)
timeFrame: 12 months
measure: Questionnaire KDQOL
timeFrame: 12 months
measure: Questionnaire SF36
timeFrame: 12 months
measure: Questionnaire KDQOL
timeFrame: 3 months
measure: Questionnaire KDQOL
timeFrame: 6 months
measure: Questionnaire SF36
timeFrame: 3 months
measure: Questionnaire SF36
timeFrame: 6 months
measure: Fistula quality (cm*ml/min)
timeFrame: Baseline
measure: Fistula quality (cm*ml/min)
timeFrame: 6 months
measure: Fistula quality (cm*ml/min)
timeFrame: 12 months
measure: % Stenosis
timeFrame: Baseline
measure: % Stenosis
timeFrame: 6 months
measure: % Stenosis
timeFrame: 12 months
measure: Presence/absence of complications associated with the angioplasty
timeFrame: Day of intervention
measure: % Stenosis
timeFrame: 3 months
measure: Presence/absence of complications since the last visit
timeFrame: 6 months
measure: Presence/absence of complications since the last visit
timeFrame: 12 months
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Eric Picard, MD
role: PRINCIPAL_INVESTIGATOR
References: