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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379366
Recruitment Status : Terminated (lack of patients)
First Posted : September 21, 2006
Last Update Posted : March 18, 2015
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

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-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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Graft Occlusion, Vascular Thrombosis Intimal Hyperplasia Device: External ionizing radiations Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerance of Transcutaneous Ionizing Radiations to Prevent Restenosis Caused by Intimal Hyperplasia on Prosthetic Haemodialysis Vascular Access
Study Start Date : December 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: 1
14 Gy ionizing radiations
Device: External ionizing radiations
14 Gy in one time

No Intervention: 2

Primary Outcome Measures :
  1. 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 ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379366

Clinc Delay
Bayonne, France, 64100
Côte Basque Hospital
Bayonne, France, 64109
Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux
Bordeaux cedex, France, 33076
Clinic Saint Augustin
Bordeaux, France, 33000
Clinic Francheville
Perigueux, France, 24000
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Principal Investigator: Jean-Philippe MAIRE, Pr University Hospital, Bordeaux, France
Study Chair: Paul Perez, Dr University Hospital, Bordeaux, France

Responsible Party: University Hospital, Bordeaux Identifier: NCT00379366     History of Changes
Other Study ID Numbers: 9443-05
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Bordeaux:
Randomized Controlled Trials
Renal Dialysis
Graft Occlusion, Vascular
Vascular Patency
Radiation, Ionizing

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Graft Occlusion, Vascular
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Postoperative Complications