The aim of the proposed study will determine new duplex ultrasound velocity (DUS) criteria for reference/normal values and in-stent re-stenosis after aorto-iliac stenting.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The patients shall undergo an Ankle-Brachial Index (in rest and after treadmill
test) (ABI), DUS and blood analysis.
Within a month an angiography (DSA) with pressure measurement (IAPM) shall be
performed.
With duplex ultrasound (DUS) the peak systolic velocity (PSV), in pre, in and
post stent area shall be measured. The elevation in blood velocity shall be
valued as PSV ratio (in-stent/pre-stent).
Within a month an angiography (DSA) with pressure measurement (IAPM) shall be
performed. During intra arterial pressure measurement (IAPM), the mean systolic
pressure shall be measured in pre, in and post stented area.
IAPM is generally known as the *golden standard*.
The PSV ratio can be compared with the pressure loss over the stented area and
the DSA (stenosis grade).
These results can serve as reference values.
Secondary outcome
Angiographic grade (morphologic view) of stenosis will also be compared with
the PSV ratio measured with DUS.
Ankle-brachial index test (ABI): In rest and after treadmill test. (see chapter
6.2)
All patients will undergo an ABI in rest and after treadmill test in order to
determine the Rutherford classification of peripheral artery disease. This
classification is the current standard for categorizing clinical assessment.
Blood analysis.
Blood analysis shall be performed for sub analysis.
If a second pressure loss is being measured after a PTA or selective stenting
and new DUS PSV ratio are being measured. These values, The Δ PSV ratio versus
the Δ pressure loss, shall be calculated and transformated in a x and y axis
table.
Background summary
Recent articles have showed that duplex ultrasound (DUS) criteria after carotid
artery stenting (CAS) have not been well-established. A potential source of
error in using DUS after CAS is that reduced compliance in the stented artery
may result in elevated velocity measured in peak systolic velocity (PSV). Also
due to re-stenosis elevated velocities can measured. Therefore, the
surveillance in patients with aorto-iliac stents is not optimal.
Study objective
The aim of the proposed study will determine new duplex ultrasound velocity
(DUS) criteria for reference/normal values and in-stent re-stenosis after
aorto-iliac stenting.
Study design
It will be a clinical cohort study .
Study burden and risks
The patients shall undergo an ABI and DUS. These tests are non-invasive with no
burden for the patients.
A DSA is an invasive test and is generally known as the golden standard. Due to
the fact that it is an invasive test it carries some risks. But it is very
important to examine these duplex criteria in order to improve the surveillance
in these patients.
Montessoriweg 1
3083 AN Rotterdam
Nederland
Montessoriweg 1
3083 AN Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
All people who have had an aorto-iliac stent due to claudication intermittens
informed consent
Exclusion criteria
impossibility to follow up
Persistent pressure loss after stenting
Design
Recruitment
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 | NL12693.101.06 |