Renal Failure Clinical Trial
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.
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.
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