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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01321866
First received: March 23, 2011
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Arteriovenous Fistula
Fistula
Procedure: Cutting balloon angioplasty
Procedure: Angioplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Primary patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Primary patency following a first angioplasty of a first stenose in the affected zone.


Secondary Outcome Measures:
  • Number of early re-stenoses [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    stenosis defined as lumen diameter < 2mm

  • Number of re-stenoses [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Stenosis defined as lumen diameter < 2mm

  • Total days in hospital [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The total number of days hospitalized for stenosis, thrombosis, or recovering vascular access. This does not include regular hemodialysis activities.

  • Number of stents used [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The total number of stents placed between the study angioplasty and the end-of-study visit.

  • Total number of venous thromboses [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Total number of venous thromboses between study angioplasty and end-of-study visit

  • Direct medical costs (€) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Indirect costs (€) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Questionnaire KDQOL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Questionnaire SF36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Questionnaire KDQOL [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Questionnaire KDQOL [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Questionnaire SF36 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Questionnaire SF36 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fistula quality (cm*ml/min) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)

  • Fistula quality (cm*ml/min) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)

  • Fistula quality (cm*ml/min) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)

  • % Stenosis [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)

  • % Stenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)

  • % Stenosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day of intervention ] [ Designated as safety issue: Yes ]
  • % Stenosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Presence/absence of complications since the last visit [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 92
Study Start Date: May 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321866

Contacts
Contact: Eric M Picard, MD +33.(0)4.66.68.39.30 eric.picard@chu-nimes.fr
Contact: Carey M Suehs, PhD 33466686788 carey.suehs@chu-nimes.fr

Locations
France
Centre Hospitalier Universitaire de Nîmes Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Eric Picard, MD         
Sub-Investigator: Pascal Branchereau, MD         
Sub-Investigator: Catalin Cosma, MD         
Sub-Investigator: Michel Dauzat, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Eric Picard, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01321866     History of Changes
Other Study ID Numbers: AOI/2010/EP-01, 2011-A00332-39
Study First Received: March 23, 2011
Last Updated: May 13, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Angioplasty
cutting balloon

Additional relevant MeSH terms:
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 16, 2014