Study on Fistuloplasty Using Flow Measurement Guidance

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.

Study Overview

• Status: Terminated
• Conditions: Renal Failure; End Stage Renal Failure on Dialysis
• Intervention / Treatment: Device: Using Flow measurements to guide fistula angioplasty (Transonics)

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Transonics flow measurements in the fistula would be used to guide the fistula intervention
No Intervention: Control arm; Patient will undergo normal fistula intervention guided only by angiographic assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reintervention	Time between intervention and the need for repeat intervention (based on standard dialysis screening systems).	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Richard Lindsay
• Investigators: Principal Investigator: David Valenti, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre; Principal Investigator: Louis Boucher, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Angioplasty
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 12-133-SDR