Renal Insufficiency, ChronicPhase 2/3RASTANCT00379366
External Ionizing Radiation to Prevent Restenosis on Haemodialysis Vascular Access
A Phase 2/3 study testing External ionizing radiations in people with Renal Insufficiency, Chronic and Graft Occlusion, Vascular, run by University Hospital, Bordeaux at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Graft Occlusion, Vascular, Thrombosis
- What is being tested?
- External ionizing radiations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesFrance
- Study dates
- Dec 2006to Jan 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- contra-indications of radiotherapy
- angioplasty with stenting
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Clinc Delay
Bayonne, 64100
Côte Basque Hospital
Bayonne, 64109
Clinic Saint Augustin
Bordeaux, 33000
Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux
Bordeaux, 33076
Clinic Francheville
Périgueux, 24000
About this study
Official 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.
Read the 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.
- Being tested
- External ionizing radiations
- Keywords
- Randomized Controlled Trials, Renal Dialysis, Graft Occlusion, Vascular, Angioplasty, Vascular Patency, Radiation, Ionizing
- Medical subject headings
- Renal Insufficiency, Chronic, Graft Occlusion, Vascular, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External ionizing radiationsDevice
14 Gy in one time
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 14 Gy ionizing radiations Receives: Device: External ionizing radiations |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis or stenosis > to 70% or indication of a new treatment of stenosis during the 12 month follow-up
Measured: 1, 3, 6 and 12 month after initial angioplasty
Secondary outcomes (2)
Stenosis (> to 70%) or thrombosis or indication of a new treatment occurring
Measured: 1, 3, 6 or 12 months after initial angioplasty
safety
Measured: 1, 3, 6 and months after initial angioplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startDec 2006
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe MAIRE, Pr, Principal investigator, University Hospital, Bordeaux, FrancePaul Perez, Dr, Study chair, University Hospital, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379366
- Sponsor's protocol ID
- 9443-05
- Other IDs
- 2005-011
- Acronym
- RASTA
- Status last verified
- Mar 2015
- First submitted
- 20 Sep 2006
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of Transcutaneous Ionizing Radiations to Prevent Restenosis Caused by Intimal Hyperplasia on Prosthetic Haemodialysis Vascular Access
- ClinicalTrials.gov ID
- NCT00379366
- Acronym / sponsor ID
- RASTA / 9443-05
- Keywords
- Randomized Controlled Trials, Renal Dialysis, Graft Occlusion, Vascular, Angioplasty, Vascular Patency, Radiation, Ionizing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Dec 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: External ionizing radiations14 Gy ionizing radiations |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- contra-indications of radiotherapy
- angioplasty with stenting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External ionizing radiations14 Gy in one time | Device | 1 |
Primary outcome
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
2 secondary outcomes
Stenosis (> to 70%) or thrombosis or indication of a new treatment occurring
Time frame: 1, 3, 6 or 12 months after initial angioplasty
safety
Time frame: 1, 3, 6 and months after initial angioplasty
Results and safety
The study was stopped early (reason given: lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe MAIRE, Pr principal investigator
University Hospital, Bordeaux, France
Paul Perez, Dr study chair
University Hospital, Bordeaux, France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing External ionizing radiations in people with Renal Insufficiency, Chronic and Graft Occlusion, Vascular, run by University Hospital, Bordeaux at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.