NCT01643733

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

4.3 years

First QC Date

July 10, 2012

Last Update Submit

March 22, 2017

Conditions

End Stage Renal Failure on DialysisRenal Failure

Keywords

Angioplasty

Outcome Measures

Primary Outcomes (1)

  • Time to reintervention

    Time between intervention and the need for repeat intervention (based on standard dialysis screening systems).

    6 months

Secondary Outcomes (4)

  • Effect of treatment on rate of change in Transonics flow measurements

    Baseline, 2 weeks, one, two three and 6 months

  • Change in dialysis efficiency post treatment

    One month, 2, 3 and six months

  • Significance of stenoses as detected by Transonics, compared with angiography

    1 day, ie.will be asessed immediately following intial intervention only.

  • Nature of Procedure using Transonics versus Angiographic assessment

    Six months

Study Arms (2)

Transonics Arm

EXPERIMENTAL

Intervention will be guided by flow through the fistula as guided by Transonics flow measurements

Device: Using Flow measurements to guide fistula angioplasty (Transonics)

Control arm

NO INTERVENTION

Patient will undergo normal fistula intervention guided only by angiographic assessment

Interventions

Using Flow measurements to guide fistula angioplasty (Transonics)DEVICE

Transonics flow measurements in the fistula would be used to guide the fistula intervention

Transonics Arm

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 18, 2012

Study Start

October 1, 2012

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

CA(2)