Our objective is to evaluate the patency of paclitaxel coated balloons in hemodialysis patients presenting at the radiology department more than once a year with repetitive severe stenoses of their fistula, and compare the results with primary…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are 12-months patency of the use of placlitaxel coated
balloons and conventional balloons. Endpoints being re-intervention, more than
50% stenosis of the treated segment of the hemodialysis fistula, occlusion of
the fistula at duplex ultrasound and blood flow below 600 ml/min.
Secondary outcome
Secondary endpoints are initial angiographic success (less than 30% stenosis),
peri-procedural complications (within 24 hrs) and late complications (within 30
days). Further secundairy endpoint are time to hemostasis of the puncture site
and diameter of hematoma arond the puncture site. Complications include balloon
rupture, vessel disruption, significant bleeding, hypotension, allergic
reaction, infection, pulmonary embolus, hand ischemia, occlusion and thrombosis
of the fistula, immediate surgical intervention and death. Also evaluation with
duplex US at 2 weeks, 3, 6, and 24 months will be taken into accopunt as
secondary study outcome.
Background summary
Dialysis Outcomes Quality Initiative (DOQI) guidelines recommend percutanous
transluminal balloonangioplasty (PTA) for the treatment of significant stenoses
in hemodialysis fistula. The initial results of PTA are often excellent.
However, midterm patency is only average (6-months primary patency of 38% to
55%). Secondary patency can be kept at an acceptable level by repeating the PTA
procedure. Improving primary patency of PTA could prevent repeated PTA
treatments. Restenosis after PTA is caused by intima hyperplasia, produced by
the smooth muscle cells in the vessel wall. Through infiltration of the vessel
wall with the paclitaxel, paclitaxel coated balloons should inhibit the
proliferation of smooth muscle cells, and thereby prevent intima hyperplasia
formation. Significant inhibition of restenosis has already been established in
the coronary arteries and the superficial femoral arteries. Our hypothesis is
that the use of paclitaxel coated balloons in stenoses of hemodialysis fistula
should increase the primary patency of PTA significantly.
Study objective
Our objective is to evaluate the patency of paclitaxel coated balloons in
hemodialysis patients presenting at the radiology department more than once a
year with repetitive severe stenoses of their fistula, and compare the results
with primary patency of conventional balloons.
Study design
Randomised multi-centre study with patients and observers blinded for patient
data.
Intervention
PTA of the vein of the hemodialysis fistula using a placlitaxel coated balloon
or a conventional balloon.
Study burden and risks
Risks and complications of PTA include disruption of the vessel wall and a
sporadic pulmonary embolus. Thus far it has never been reported that PTA using
a paclitaxel coated balloon causes more complications than PTA with the use of
a conventional PTA balloon. With the removal of the sheath after the procedure
and subsequent pressure at the puncture site a rebleed or hematoma could occur.
The use of paclitaxel could potentially increase blood plasma levels of
paclitaxel. Reported blood plasma concentrations after the use of paclitaxel
coated balloons all remained below the level of 0.01 mg/ml. Furthermore, it was
established that pharmacodynamic parameters of paclitaxel were independent of
renal function. Patients will be asked to undergo duplex ultrasound
examinations of their fistula at 2 weeks, 3, 6, 12 and 24 months after
treatment. Further, baseline characteristics will be noted.
Albert Schweitzerplaats 25
3318 AT Dordrecht
NL
Albert Schweitzerplaats 25
3318 AT Dordrecht
NL
Listed location countries
Age
Inclusion criteria
Hemodialysis patients presenting more than once a year with repetitive severe stenoses of the draining vein of the fistula, evaluated with duplex ultrasound and reconfirmed at angiography. Patients with a life expectancy of at least one year will be included.
Exclusion criteria
Refusal or no motivation to participate in the study or receive PTA treatment. Pregnancy or planing to become pregnant during the study. Known allergic reactions in the past with regard to iodinated contrast agents, paclitaxel, heparine or aspirine. Under 18 years of age.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33371.100.10 |