Thrombosis Clinical Trial
— RASTAOfficial title:
Efficacy and Tolerance of Transcutaneous Ionizing Radiations to Prevent Restenosis Caused by Intimal Hyperplasia on Prosthetic Haemodialysis Vascular Access
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-muscle cell proliferation and restenosis on prosthetic haemodialysis vascular access. We will assess the preventive effect of one dose of radiations (14 Gy) administered transcutaneously one day after dilatation of stenosis on prosthetic haemodialysis vascular access in a randomized controlled trial with a standardized clinical and ultrasonographic one-year follow-up.
Status | Terminated |
Enrollment | 5 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - contra-indications of radiotherapy - angioplasty with stenting |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Clinc Delay | Bayonne | |
France | Côte Basque Hospital | Bayonne | |
France | Clinic Saint Augustin | Bordeaux | |
France | Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux | Bordeaux cedex | |
France | Clinic Francheville | Perigueux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Thrombosis or stenosis > to 70% or indication of a new treatment of stenosis during the 12 month follow-up | 1, 3, 6 and 12 month after initial angioplasty | No | |
Secondary | Stenosis (> to 70%) or thrombosis or indication of a new treatment occurring | 1, 3, 6 or 12 months after initial angioplasty | No | |
Secondary | safety | 1, 3, 6 and months after initial angioplasty | Yes |
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