TerminatedNCT01643733Updated Mar 27, 2017

Study on Fistuloplasty Using Flow Measurement Guidance

An interventional study of Using Flow measurements to guide fistula angioplasty (Transonics) in End Stage Renal Failure on Dialysis and Renal Failure, sponsored by Richard Lindsay. Terminated at 2 sites in Canada. Open to participants aged 16 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by Richard Lindsay · Not applicable, Interventional, and Treatment

Why this study was terminated

Not enough recruitment

Phase: Not applicable
Study type: Interventional
Enrollment: 26
Allocation: Randomized
Ages: 16 Years to 90 Years
Sex: All

Study 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 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 studied

End Stage Renal Failure on Dialysis
Renal Failure

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Keywords

Angioplasty

In context

Renal Insufficiency

1,994 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 26 is below the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Richard Lindsay is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.
Patients whose fistulae have never become functional.
Patients with PTFE grafts/non-native fistulae
Patients who have had previous stenting of fistulae

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Investigator, Outcomes assessor)
Enrollment: 26 participants (actual)

Study arms

Experimental
Transonics Arm
Intervention will be guided by flow through the fistula as guided by Transonics flow measurements
Device: Using Flow measurements to guide fistula angioplasty (Transonics)
No intervention
Control arm
Patient will undergo normal fistula intervention guided only by angiographic assessment

Interventions

DeviceUsing Flow measurements to guide fistula angioplasty (Transonics)
Transonics flow measurements in the fistula would be used to guide the fistula intervention

What researchers measure

Primary outcomes

Time to reintervention
Time between intervention and the need for repeat intervention (based on standard dialysis screening systems).
Time frame: 6 months

Secondary outcomes

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
Time frame: Baseline, 2 weeks, one, two three and 6 months
Change in dialysis efficiency post treatment
Comparison of Dialysis efficiency scores pre and post treatment
Time frame: 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.
Time frame: 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.
Time frame: Six months

Study locations

2 sites

Royal Victoria Hospital
Montreal, Quebec H3A 1A1, Canada
Montreal General Hospital
Montreal, Quebec H3G 1A4, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01643733
Lead sponsor: Richard Lindsay
Responsible party: Richard Lindsay (MD, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Sponsor-investigator
First posted: Jul 18, 2012
Start date: Oct 2012
Primary completion: Feb 2017
Completion: Feb 2017
Last update: Mar 27, 2017

Study contacts

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

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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