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

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:

Genetics Home Reference related topics: capillary malformation-arteriovenous malformation syndrome Parkes Weber syndrome

MedlinePlus related topics: Angioplasty Dialysis Fistulas

U.S. FDA Resources

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: 1 month ] [ 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:	March 2016
Estimated Primary Completion Date:	March 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 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

Contacts and Locations

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:	March 22, 2013
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:

Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities

Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013

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