To demonstrate the efficacy of a PTFE covered stent-graft in the prevention of outflow re-stenosis in loop fistula in a prospective trial.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
Primary patency
Secondary patency
Graft failure
Secondary outcome
Secondary endpoints
Number of radiological re-interventions
Number of Surgical interventions
Graft infection
Background summary
Haemodialysis access surgery in patients with end-stage renal disease remains
challenging due to of a high incidence of complications. Vascular access
complications occur in up to 40% of patients with polytetrafluorethylene
(ePTFE) grafts within the first 6 months, primarily due to stenosis and
thrombosis. Stenosis at the venous anastomosis or in the draining vein may be
treated by either angioplasty or surgical intervention. Following angioplasty,
however, recurrent stenoses frequently occur. The viabahn stent-graft is a
combined ePTFE-Nitinol self-expanding stent-graft preloaded on a catheter-based
delivery system. Its flexibility might make the device ideal for the treatment
of recurrent outflow stenosis in AV loop-fistula.
Study objective
To demonstrate the efficacy of a PTFE covered stent-graft in the prevention of
outflow re-stenosis in loop fistula in a prospective trial.
Study design
The design of this trial is a non-randomized mono-centred prospective
intervention (pilot) study.
Intervention
In all patients an angioplasty will be performed with a high-pressure balloon,
according to local protocols. If indicated, a cutting balloon may be used.
After dilatation a 5 cm viabahn will be placed.
Study burden and risks
Patients with ePTFE grafts of arteriovenous fistula for hemodialysis purpose
receive repeatedly endovasculair treatment because of high incidence of
stenosis and thrombosis of these grafts. If this does not suffice, surgery is
necessary to maintain access to circulation.
With recurring stenosis of such grafts, a single endovasculair procedure will
be performed during which a viabahn stent will be placed. The procedure is not
more aggravating than and is as hazardous as standard endovasculair procedures.
During follow-up monthly duplex flow measurements will be performed. This is
not invasive and not aggravating for patients It will be performed during
regular visits for purpose of hemodialysis.
Six and twelve months after stenting, angiography will be performed for
evaluation purpose.
Ringbaan Oost 152a
5013 CE Tilburg
NL
Ringbaan Oost 152a
5013 CE Tilburg
NL
Listed location countries
Age
Inclusion criteria
Patient of 18 years of age
Patient has a life expectancy of at least 2 years
Patient has re- stenosis within 2 cm from the anastomosis of a loop arterio venous fistula
Signed informed consent
Exclusion criteria
Patient unsuitable for administration of contrast agent
Dementio or atered mental status that would prohibit giving conscious informed consent
Need for adjunctive major surgical procedures within 1 month
Other stenosis
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 | NL18459.091.07 |