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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


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
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