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

NCT ID: NCT01321866

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Arteriovenous Fistula; Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental arm

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

Group Type: EXPERIMENTAL

Cutting balloon angioplasty

Intervention Type: PROCEDURE

Angioplasty of fistula stenosis using a cutting balloon

Standard arm

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

Group Type: ACTIVE_COMPARATOR

Angioplasty

Intervention Type: PROCEDURE

Angioplasty of fistula stenosis using a non-cutting balloon

Interventions

Cutting balloon angioplasty

Angioplasty of fistula stenosis using a cutting balloon

Intervention Type: PROCEDURE

Angioplasty

Angioplasty of fistula stenosis using a non-cutting balloon

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Picard, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Countries

France

Other Identifiers

2011-A00332-39

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2010/EP-01

Identifier Type: -

Identifier Source: org_study_id