External Ionizing Radiation to Prevent Restenosis on Haemodialysis Vascular Access (RASTA)

March 17, 2015 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 accesses remain patent at one year. No available pharmacological agents can yet effectively prevent it. After stenosis dilatation the vascular wall responds to mechanical injury in a standardized manner: intimal smooth-muscle cells migrate and proliferate, a neointima gradually begins to form and the cell phenotype changes from contractile to secretory. One way to inhibit the neointimal proliferation responsible for restenosis is to induce cell apoptosis by delivering ionizing radiations to the dilated area after the endovascular procedure. Experimental studies and multicenter clinical trials have reported the beneficial effects of endovascular beta or gamma ionizing radiation on vascular restenosis. Experimental studies in animals and recent clinical trials clearly show that external irradiation also reduces neointimal proliferation after arterial injury thus opening the way for the clinical assessment of ionizing radiations on arteries. In a previous experimental study, we reported that irradiation has a dose-dependent effect on the prevention of restenosis: a dose larger than 10 Gy is needed to obtain a significant reduction of intimal hyperplasia.

Objective: the main objective is to assess external ionizing radiation for restenosis prevention on prosthetic haemodialysis vascular accesses after angioplasty. A secondary objective is to assess the treatment safety.

Methods: Single blind randomized clinical trial on two parallel groups of 53 patients each. Patients with chronic renal failure treated by dialysis will be included after a successful angioplasty on a stenosis of the vein adjacent to their prosthetic haemodialysis vascular access. One group will be treated by a single dose of ionizing radiations (14 Gy) at day 1 after angioplasty. The control group will not receive any preventive treatment. The primary outcome is the one-year vascular access patency failure. Secondary outcomes are the one-year delay of occurrence of a restenosis and the treatment safety. Outcomes will be assessed by a clinical and ultrasonographic (at 1, 3, 6 and 12 months, or at other time points in case of stenosis suspicion) follow-up.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bayonne, France, 64100
        • Clinc Delay
      • Bayonne, France, 64109
        • Côte Basque Hospital
      • Bordeaux, France, 33000
        • Clinic Saint Augustin
      • Bordeaux cedex, France, 33076
        • Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux
      • Perigueux, France, 24000
        • Clinic Francheville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Active Comparator: 1
14 Gy ionizing radiations
Device: External ionizing radiations
14 Gy in one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thrombosis or stenosis > to 70% or indication of a new treatment of stenosis during the 12 month follow-up
Time Frame: 1, 3, 6 and 12 month after initial angioplasty
1, 3, 6 and 12 month after initial angioplasty

Secondary Outcome Measures

Outcome Measure
Time Frame
Stenosis (> to 70%) or thrombosis or indication of a new treatment occurring
Time Frame: 1, 3, 6 or 12 months after initial angioplasty
1, 3, 6 or 12 months after initial angioplasty
safety
Time Frame: 1, 3, 6 and months after initial angioplasty
1, 3, 6 and months after initial angioplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Jean-Philippe MAIRE, Pr, University Hospital, Bordeaux, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 20, 2006

First Submitted That Met QC Criteria

September 20, 2006

First Posted (Estimate)

September 21, 2006

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9443-05
  • 2005-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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