End Stage Renal Failure on DialysisNCT01643733
Study on Fistuloplasty Using Flow Measurement Guidance
A study testing Using Flow measurements to guide fistula angioplasty (Transonics) in people with End Stage Renal Failure on Dialysis and Renal Failure, run by Richard Lindsay at 2 sites in Canada.
Trial summary
Hypothesis: The primary objective of this study is to assess whether using a flow measurement device, in this case the Transonics flow device, as an end-point to interventional treatment of diseased dialysis fistulae can help increase immediate treatment success in terms of quality of dialysis immediately following… Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- End Stage Renal Failure on Dialysis, Renal Failure
- What is being tested?
- Using Flow measurements to guide fistula angioplasty (Transonics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2012to Feb 2017
- Phase
- Interventional
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
- Subjects referred to us from the Dialysis units located in the study centres for clinically indicated fistulogram and fistula treatment.
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures
Who cannot join
- Significant coagulopathy that cannot be adequately corrected.
- Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
- Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Patients will only be excluded on this basis following discussion with another interventional radiologist and the referring nephrologist.
- Subjects who are uncooperative or cannot follow instructions.
- Mental state that may preclude completion of the study procedure or ability to obtain informed consent.
- Pregnant or nursing female subjects.
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- Patients whose fistulae have never become functional.
- Patients with PTFE grafts/non-native fistulae
- Patients who have had previous stenting of fistulae
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Montreal General Hospital
Montreal, Quebec, H3G 1A4
About this study
Official title: Confirmation of Clinical Effectiveness and Safety of Use of Transonics in Determining Success of Intervention in Dialysis Fistulae
Hypothesis: The primary objective of this study is to assess whether using a flow measurement device, in this case the Transonics flow device, as an end-point to interventional treatment of diseased dialysis fistulae can help increase immediate treatment success in terms of quality of dialysis immediately following the treatment and increasing time to reintervention.
Read the detailed description
This is a prospective randomized study. All intervention will be carried out by experienced radiologists in the two study centres.
At least fifty (50) consecutive subjects meeting the eligibility criteria, scheduled for angiographic assessment (with a view to PTA if necessary), will be invited to participate in the study. Subjects who consent will undergo their procedure, which will be performed by a qualified interventional radiology doctor (IRD). Patients will be randomly allocated to each group. All previous Transonics measurements will be available to the treating IRD. A target flow rate will be pre-decided in all patients in consultation with the nephrology service.
- All patients will undergo a fistulogram, a routine interventional Xray exam where radiocontrast media (RCM) is injected under X ray control to identify narrowings within the vessels. Significant lesions will be identified based on this exam. If a lesion is believed to be significant, the patient will be assigned to either arm of the study. The details of the disease present will be recorded as location and percentage stenosis.
- In the control arm, an initial Transonic measurement pre-treatment will be performed. The interventionalist will select the most significant lesion based on angiographic appearances and treat this lesion, which may require use of multiple balloons for the same lesion. At this point a Transonics measurement will be taken - Measurement A. The results will not be revealed to the interventionalist, who will proceed with the procedure as per their standard practice. A Transonics measurement will be taken after treatment of each of the significant lesions identified at the start of the exam. A post-procedural Transonics measurement (Measurement X) will also be taken, again the interventionalist will blinded as to this result. The appearances on completion angiography will be recorded as percentage stenosis remaining.
- In the Transonics arm, a pre-treatment Transonic measurement will be done. The lesions will be treated. Once Measurement A is obtained, the interventionalist will only be informed if the target value has been reached or not, they will not be told the actual value. This will be repeated for the treatment of each subsequent lesion, with the interventionalist being informed if the target had been reached, whilst being blinded as to the Transonics result, until the target has been achieved. The interventionalist will not pursue further treatment, regardless of the Transonics measurement, if he deems it would pose a greater risk of complication to the patient, than his/her standard practice. The appearances on completion angiography will be recorded as percentage stenosis remaining.
- Conditions
- End Stage Renal Failure on Dialysis, Renal Failure
- Being tested
- Using Flow measurements to guide fistula angioplasty (Transonics)
- Keywords
- Angioplasty
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Flow measurements to guide fistula angioplasty (Transonics)Device
Transonics flow measurements in the fistula would be used to guide the fistula intervention
| Study group | Role | What they receive |
|---|---|---|
| Transonics Arm | Experimental | Intervention will be guided by flow through the fistula as guided by Transonics flow measurements Receives: Device: Using Flow measurements to guide fistula angioplasty (Transonics) |
| Control arm | No intervention | Patient will undergo normal fistula intervention guided only by angiographic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reintervention
Time between intervention and the need for repeat intervention (based on standard dialysis screening systems).
Measured: 6 months
Secondary outcomes (4)
Effect of treatment on rate of change in Transonics flow measurements
Analysis of Transonics flow measurements obtained post intervention during the follow-up of six months
Measured: Baseline, 2 weeks, one, two three and 6 months
Change in dialysis efficiency post treatment
Comparison of Dialysis efficiency scores pre and post treatment
Measured: One month, 2, 3 and six months
Significance of stenoses as detected by Transonics, compared with angiography
Assessment of extent to which using flow measurements can improve ability to detect hemodynamically significant stenoses.
Measured: 1 day, ie.will be asessed immediately following intial intervention only.
Nature of Procedure using Transonics versus Angiographic assessment
Comparison of procedures carried out between the group where Transonics flow measurements are used to guide intervention, versus the group where angiographic assessment is used.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Not enough recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Lindsay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Lindsay, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- David Valenti, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreLouis Boucher, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643733
- Sponsor's protocol ID
- 12-133-SDR
- Status last verified
- Mar 2017
- First submitted
- 10 Jul 2012
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of Clinical Effectiveness and Safety of Use of Transonics in Determining Success of Intervention in Dialysis Fistulae
- ClinicalTrials.gov ID
- NCT01643733
- Acronym / sponsor ID
- 12-133-SDR
- Conditions
- End Stage Renal Failure on Dialysis, Renal Failure
- Keywords
- Angioplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough recruitment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Richard LindsayUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 18 Jul 2012 (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.
Hypothesis: The primary objective of this study is to assess whether using a flow measurement device, in this case the Transonics flow device, as an end-point to interventional treatment of diseased dialysis fistulae can help increase immediate treatment success in terms of quality of dialysis immediately following the treatment and increasing time to reintervention.
Detailed description
This is a prospective randomized study. All intervention will be carried out by experienced radiologists in the two study centres.
At least fifty (50) consecutive subjects meeting the eligibility criteria, scheduled for angiographic assessment (with a view to PTA if necessary), will be invited to participate in the study. Subjects who consent will undergo their procedure, which will be performed by a qualified interventional radiology doctor (IRD). Patients will be randomly allocated to each group. All previous Transonics measurements will be available to the treating IRD. A target flow rate will be pre-decided in all patients in consultation with the nephrology service.
- All patients will undergo a fistulogram, a routine interventional Xray exam where radiocontrast media (RCM) is injected under X ray control to identify narrowings within the vessels. Significant lesions will be identified based on this exam. If a lesion is believed to be significant, the patient will be assigned to either arm of the study. The details of the disease present will be recorded as location and percentage stenosis.
- In the control arm, an initial Transonic measurement pre-treatment will be performed. The interventionalist will select the most significant lesion based on angiographic appearances and treat this lesion, which may require use of multiple balloons for the same lesion. At this point a Transonics measurement will be taken - Measurement A. The results will not be revealed to the interventionalist, who will proceed with the procedure as per their standard practice. A Transonics measurement will be taken after treatment of each of the significant lesions identified at the start of the exam. A post-procedural Transonics measurement (Measurement X) will also be taken, again the interventionalist will blinded as to this result. The appearances on completion angiography will be recorded as percentage stenosis remaining.
- In the Transonics arm, a pre-treatment Transonic measurement will be done. The lesions will be treated. Once Measurement A is obtained, the interventionalist will only be informed if the target value has been reached or not, they will not be told the actual value. This will be repeated for the treatment of each subsequent lesion, with the interventionalist being informed if the target had been reached, whilst being blinded as to the Transonics result, until the target has been achieved. The interventionalist will not pursue further treatment, regardless of the Transonics measurement, if he deems it would pose a greater risk of complication to the patient, than his/her standard practice. The appearances on completion angiography will be recorded as percentage stenosis remaining.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transonics Arm | Experimental | Device: Using Flow measurements to guide fistula angioplasty (Transonics)Intervention will be guided by flow through the fistula as guided by Transonics flow measurements |
| Control arm | No intervention | –Patient will undergo normal fistula intervention guided only by angiographic assessment |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
- Subjects referred to us from the Dialysis units located in the study centres for clinically indicated fistulogram and fistula treatment.
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures
Key exclusion criteria (9 listed)
- Significant coagulopathy that cannot be adequately corrected.
- Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
- Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Patients will only be excluded on this basis following discussion with another interventional radiologist and the referring nephrologist.
- Subjects who are uncooperative or cannot follow instructions.
- Mental state that may preclude completion of the study procedure or ability to obtain informed consent.
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 |
|---|---|---|
| Using Flow measurements to guide fistula angioplasty (Transonics)Transonics flow measurements in the fistula would be used to guide the fistula intervention | Device | Transonics Arm |
Primary outcome
Time to reintervention
Time frame: 6 months
Time between intervention and the need for repeat intervention (based on standard dialysis screening systems).
4 secondary outcomes
Effect of treatment on rate of change in Transonics flow measurements
Time frame: Baseline, 2 weeks, one, two three and 6 months
Change in dialysis efficiency post treatment
Time frame: One month, 2, 3 and six months
Significance of stenoses as detected by Transonics, compared with angiography
Time frame: 1 day, ie.will be asessed immediately following intial intervention only.
Nature of Procedure using Transonics versus Angiographic assessment
Time frame: Six months
Results and safety
The study was stopped early (reason given: Not enough recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
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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.
David Valenti, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Louis Boucher, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using Flow measurements to guide fistula angioplasty (Transonics) in people with End Stage Renal Failure on Dialysis and Renal Failure, run by Richard Lindsay at 2 sites in Canada.
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 9 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
Are results available for this study?
The study was stopped early (reason given: Not enough recruitment). 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?
Time to reintervention (time frame: 6 months). 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 27 Mar 2017; AzTrials last refreshed its copy on 30 Oct 2026.