This is a safety and feasibility study to assess the technical use of a pressure guidewire and monorail infusion catheter to measure intracranial intra-arterial pressure and absolute flow.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main parameters of interest are intracranial intra-arterial pressure, flow and
resistance measurements of the left and right internal carotid, middle cerebral
and vertebral arteries. Procedural safety outcomes will be documented.
Secondary outcome
The reproducibility (first vs. second measurement, and right vs. left), the
influence of a different infusion rates of saline (low vs. high rate), and the
influence of sensor position (distal vs. proximal) will be evaluated by
linear regression analysis and with Bland-Altman plots. Hemodynamic data will
be reported per case.
Background summary
In the emerging neurovascular field there is a need for valid intracranial
intra-arterial pressure, flow and resistance measurements to guide treatment
decisions in the setting of both ischemic and hemorrhagic stroke and to perform
research on development of new devices for neurovascular interventions.
However, studies on evaluation of these measurements are lacking as opposed to
the field of cardiology in which these techniques have been well established.
Study objective
This is a safety and feasibility study to assess the technical use of a
pressure guidewire and monorail infusion catheter to measure intracranial
intra-arterial pressure and absolute flow.
Study design
Single center prospective cohort study
Study burden and risks
The patients will undergo the study procedure in the setting of an already
planned DSA. The known risks associated with a regular DSA examination also
apply to the use of the study wire and catheter (low risk of an inguinal
hematoma and a very low risk of vascular damage such as dissection, occlusion
and perforation). Moreover, the advantage of both the Rayflow catheter and the
PressurewireX is the possibility of interchanging these with the guidewires and
catheters already available on the market for neurovascular assessment.
Intracranial manoeuvring is hereby very limited and only considers the
introduction of the wire over a segment of approximately 3 cm intracranially
into the vessel of interest. Since the route to the vessel of interest has
already been obtained by manoeuvring with the known standard available guide
wires and catheters during the regular workup DSA and the overall risk of
serious complications is already very low, the additional risk of complications
seen during/after a regular DSA as a result of the research intervention is
considered to be negligible. The evaluation of the microcirculation opens a new
door to the evaluation of various syndromes (microcirculation dysfunction after
a cerebral infarction, vasculitis, stenosis) but also provides prognostic
values and can contribute to direct evaluation of therapy effect during
angiography (vascular spasm, microcirculation dysfunction after an ischemic
stroke).
Dr. Molewaterplein 40
Rotterdam 3000CA
NL
Dr. Molewaterplein 40
Rotterdam 3000CA
NL
Listed location countries
Age
Inclusion criteria
- Age 18 years or older
- Scheduled for diagnostic digital subtraction angiography (for the indication
of Cerebral aneurysm, Tinnitus, Vasculitis, Follow-up after earlier
embolization or neurosurgery) undergoing complete work-up of intracranial
vessels (injection of at least left and right internal carotid artery)
- Written informed consent obtained
Exclusion criteria
- Any previous stroke or known neurological disorder associated with permanent
structural brain abnormalities
- An untreated arteriovenous malformation in the anterior cerebral circulation
- Known history of:
o connective tissue disease
o significant stenosis of the common or internal carotid artery
o dissection in the internal carotid artery
- Hypercoagulability
- Physical or psychiatric condition making it for the patient impossible or
uncomfortable to lay still during the procedure
- Visual pathology assessed during the diagnostic work-up that could interfere
with the measurements.
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 | NL84877.078.24 |