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

Arteriovenous Fistula Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01321866
• Other study ID #: AOI/2010/EP-01
• Secondary ID: 2011-A00332-39
• Status: Terminated
• Phase: N/A
• First received: March 23, 2011
• Last updated: June 2, 2016
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Procedure:
• Cutting balloon angioplasty
Angioplasty of fistula stenosis using a cutting balloon
• Angioplasty
Angioplasty of fistula stenosis using a non-cutting balloon

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency	Primary patency following a first angioplasty of a first stenose in the affected zone.	12 months	Yes
Secondary	Number of early re-stenoses	stenosis defined as lumen diameter < 2mm	3 months	No
Secondary	Number of re-stenoses	Stenosis defined as lumen diameter < 2mm	12 months	No
Secondary	Total days in hospital	The total number of days hospitalized for stenosis, thrombosis, or recovering vascular access. This does not include regular hemodialysis activities.	12 months	No
Secondary	Number of stents used	The total number of stents placed between the study angioplasty and the end-of-study visit.	12 months	No
Secondary	Total number of venous thromboses	Total number of venous thromboses between study angioplasty and end-of-study visit	12 months	No
Secondary	Direct medical costs (€)		12 months	No
Secondary	Indirect costs (€)		12 months	No
Secondary	Questionnaire KDQOL		12 months	No
Secondary	Questionnaire SF36		12 months	No
Secondary	Questionnaire KDQOL		3 months	No
Secondary	Questionnaire KDQOL		6 months	No
Secondary	Questionnaire SF36		3 months	No
Secondary	Questionnaire SF36		6 months	No
Secondary	Fistula quality (cm*ml/min)	cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)	Baseline	No
Secondary	Fistula quality (cm*ml/min)	cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)	6 months	No
Secondary	Fistula quality (cm*ml/min)	cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)	12 months	No
Secondary	% Stenosis	100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)	Baseline	No
Secondary	% Stenosis	100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)	6 months	No
Secondary	% Stenosis	100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)	12 months	No
Secondary	Presence/absence of complications associated with the angioplasty		Day of intervention	Yes
Secondary	% Stenosis	100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)	3 months	No
Secondary	Presence/absence of complications since the last visit		6 months	Yes
Secondary	Presence/absence of complications since the last visit		12 months	Yes