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

June 2, 2016 updated by: Centre Hospitalier Universitaire de Nīmes

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Gard
      • Nîmes Cedex 09, Gard, France, 30029
        • Centre Hospitalier Universitaire de Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Eric Picard, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI/2010/EP-01
  • 2011-A00332-39 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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