Status:
TERMINATED
External Ionizing Radiation to Prevent Restenosis on Haemodialysis Vascular Access
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Renal Insufficiency, Chronic
Graft Occlusion, Vascular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Although ionizing radiations have been proposed for the prevention of intimal hyperplasia in coronary and peripheral arteries, information is lacking on how irradiation may prevent neointimal smooth-m...
Detailed Description
Background: one of the major clinical concerns of prosthetic haemodialysis access is the risk of possible restenosis after stenosis dilatation. Only 25% of dilated prosthetic haemodialysis vascular ac...
Eligibility Criteria
Inclusion
- over 18 years
- successful angioplasty (residual stenosis \< 30%) on a significant stenosis (maximal systolic speed 3 times \> from basal maximal systolic speed, stenosis \> 70% on angiography) on the venous-prosthesis anastomosis or on the venous segment 5 cm after the anastomosis of a prosthetic haemodialysis vascular access (at least 1 month old)
- social security affiliation
- signed informed consent
Exclusion
- contra-indications of radiotherapy
- angioplasty with stenting
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00379366
Start Date
December 1 2006
End Date
January 1 2009
Last Update
March 18 2015
Active Locations (5)
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1
Clinc Delay
Bayonne, France, 64100
2
Côte Basque Hospital
Bayonne, France, 64109
3
Clinic Saint Augustin
Bordeaux, France, 33000
4
Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux
Bordeaux, France, 33076