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

Primary Purpose

Arteriovenous Fistula, Fistula

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cutting balloon angioplasty
Angioplasty
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Fistula focused on measuring Angioplasty, cutting balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Nîmes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental arm

Standard arm

Arm Description

Patients in this arm will have angioplasty of a fistula stenosis using a cutting balloon

Patients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2011
Last Updated
June 2, 2016
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01321866
Brief Title
Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients
Acronym
PREST
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Inclusion curve too slow.
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula, Fistula
Keywords
Angioplasty, cutting balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Patients in this arm will have angioplasty of a fistula stenosis using a cutting balloon
Arm Title
Standard arm
Arm Type
Active Comparator
Arm Description
Patients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon.
Intervention Type
Procedure
Intervention Name(s)
Cutting balloon angioplasty
Intervention Description
Angioplasty of fistula stenosis using a cutting balloon
Intervention Type
Procedure
Intervention Name(s)
Angioplasty
Intervention Description
Angioplasty of fistula stenosis using a non-cutting balloon
Primary Outcome Measure Information:
Title
Primary patency
Description
Primary patency following a first angioplasty of a first stenose in the affected zone.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of early re-stenoses
Description
stenosis defined as lumen diameter < 2mm
Time Frame
3 months
Title
Number of re-stenoses
Description
Stenosis defined as lumen diameter < 2mm
Time Frame
12 months
Title
Total days in hospital
Description
The total number of days hospitalized for stenosis, thrombosis, or recovering vascular access. This does not include regular hemodialysis activities.
Time Frame
12 months
Title
Number of stents used
Description
The total number of stents placed between the study angioplasty and the end-of-study visit.
Time Frame
12 months
Title
Total number of venous thromboses
Description
Total number of venous thromboses between study angioplasty and end-of-study visit
Time Frame
12 months
Title
Direct medical costs (€)
Time Frame
12 months
Title
Indirect costs (€)
Time Frame
12 months
Title
Questionnaire KDQOL
Time Frame
12 months
Title
Questionnaire SF36
Time Frame
12 months
Title
Questionnaire KDQOL
Time Frame
3 months
Title
Questionnaire KDQOL
Time Frame
6 months
Title
Questionnaire SF36
Time Frame
3 months
Title
Questionnaire SF36
Time Frame
6 months
Title
Fistula quality (cm*ml/min)
Description
cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)
Time Frame
Baseline
Title
Fistula quality (cm*ml/min)
Description
cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)
Time Frame
6 months
Title
Fistula quality (cm*ml/min)
Description
cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)
Time Frame
12 months
Title
% Stenosis
Description
100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)
Time Frame
Baseline
Title
% Stenosis
Description
100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)
Time Frame
6 months
Title
% Stenosis
Description
100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)
Time Frame
12 months
Title
Presence/absence of complications associated with the angioplasty
Time Frame
Day of intervention
Title
% Stenosis
Description
100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)
Time Frame
3 months
Title
Presence/absence of complications since the last visit
Time Frame
6 months
Title
Presence/absence of complications since the last visit
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Picard, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes Cedex 09
State/Province
Gard
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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