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

NCT01321866 | Terminated DMC

• 2 other identifiers: AOI/2010/EP-012011-A00332-39
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Angioplasty; cutting balloon

Outcome Measures

Primary Outcomes (1)

• Primary patency

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

  12 months

Secondary Outcomes (23)

• Number of early re-stenoses

  3 months

• Number of re-stenoses

  12 months

• Total days in hospital

  12 months

• Number of stents used

  12 months

• Total number of venous thromboses

  12 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Procedure: Cutting balloon angioplasty

Standard arm

ACTIVE COMPARATOR

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

Procedure: Angioplasty

Interventions

Cutting balloon angioplasty PROCEDURE

Angioplasty of fistula stenosis using a cutting balloon

Experimental arm

Angioplasty PROCEDURE

Angioplasty of fistula stenosis using a non-cutting balloon

Standard arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Fistula

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Eric Picard, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: May 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 3, 2016

Record last verified: 2016-06

Locations

FR (1)