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

This study has been terminated.
(lack of patients)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00379366
First received: September 20, 2006
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Renal Insufficiency, Chronic
Graft Occlusion, Vascular
Thrombosis
Intimal Hyperplasia
Device: External ionizing radiations
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stenosis (> to 70%) or thrombosis or indication of a new treatment occurring [ Time Frame: 1, 3, 6 or 12 months after initial angioplasty ] [ Designated as safety issue: No ]
  • safety [ Time Frame: 1, 3, 6 and months after initial angioplasty ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: December 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
14 Gy ionizing radiations
Device: External ionizing radiations
14 Gy in one time
No Intervention: 2

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379366

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

No publications provided

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00379366     History of Changes
Other Study ID Numbers: 9443-05, 2005-011
Study First Received: September 20, 2006
Last Updated: February 12, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on July 20, 2014