Study on Fistuloplasty Using Flow Measurement Guidance

This study is currently recruiting participants.
Verified October 2012 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01643733
First received: July 10, 2012
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Renal Dialysis
Renal Failure
Device: Using Flow measurements to guide fistula angioplasty (Transonics)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Confirmation of Clinical Effectiveness and Safety of Use of Transonics in Determining Success of Intervention in Dialysis Fistulae

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Time to reintervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Time between intervention and the need for repeat intervention (based on standard dialysis screening systems).


Secondary Outcome Measures:
  • Effect of treatment on rate of change in Transonics flow measurements [ Time Frame: Baseline, 2 weeks, one, two three and 6 months ] [ Designated as safety issue: No ]
    Analysis of Transonics flow measurements obtained post intervention during the follow-up of six months

  • Change in dialysis efficiency post treatment [ Time Frame: One month, 2, 3 and six months ] [ Designated as safety issue: No ]
    Comparison of Dialysis efficiency scores pre and post treatment

  • Significance of stenoses as detected by Transonics, compared with angiography [ Time Frame: 1 day, ie.will be asessed immediately following intial intervention only. ] [ Designated as safety issue: No ]
    Assessment of extent to which using flow measurements can improve ability to detect hemodynamically significant stenoses.

  • Nature of Procedure using Transonics versus Angiographic assessment [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643733

Contacts
Contact: Richard Lindsay, MB Bch BaO 5149341934 rwklindsay@hotmail.com

Locations
Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Principal Investigator: Richard Lindsay, Mb Bch BaO         
Principal Investigator: Louis Boucher, MD         
Principal Investigator: David Valenti, MD         
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Principal Investigator: Richard Lindsay, MB Bch BaO         
Principal Investigator: Louis Boucher, MD         
Principal Investigator: David Valenti, MD         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: David Valenti, MD McGill University Health Center
Principal Investigator: Louis Boucher, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: McGill University Health Center
ClinicalTrials.gov Identifier: NCT01643733     History of Changes
Other Study ID Numbers: 12-133-SDR
Study First Received: July 10, 2012
Last Updated: October 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
Angioplasty

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014