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External Ionizing Radiation to Prevent Restenosis on Haemodialysis Vascular Access

NCT00379366 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-03-18

No results posted yet for this study

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-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.

Conditions

  • Renal Insufficiency, Chronic
  • Graft Occlusion, Vascular
  • Thrombosis
  • Intimal Hyperplasia

Interventions

DEVICE

External ionizing radiations

14 Gy in one time

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Jean-Philippe MAIRE, Pr · University Hospital, Bordeaux, France

  • Paul Perez, Dr · University Hospital, Bordeaux, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00379366 on ClinicalTrials.gov