Primary objective: -To determine the accuracy of sCTA compared to DSA in the visualisation of the degree of occlusion in the FU of intracranial aneurysms treated with Surpass. Secondary objectives:-To determine the accuracy of sCTA compared to DSA…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter is the difference in the degree of aneurysm occlusion. This
will be measured by:
- Calculation of the aneurysm volume with residual contrast filling.
- The Raymond classification.
Secondary outcome
Secondary parameters:
The patency of the parent vessel will be measured on a 4-point scale.
Complications will be registered.
Background summary
Using flow diverters (stent-like implants that divert the flow from the
aneurysm sac) to treat unruptured intracranial aneurysms is increasingly
accepted as the treatment of choice. Nowadays, the gold standard for
radiological follow*up (FU) to evaluate the degree of occlusion of aneurysms is
digital subtraction angiography (DSA). Some non-invasive diagnostic methods
have also been described, but there is a lack of evidence about their
reliability.
Subtraction CT angiography (sCTA) is a promising non-invasive technique with an
accurate spatial resolution that could theoretically provide the same
information as DSA.
As reported in the literature (occlusion rate 75-94% at 6-month FU), our
Surpass series shows that at the 6-month FU, some aneurysms are not occluded;
94% of those with a complete neck coverage had complete occlusion, whereas 50%
of the aneurysms with incomplete neck coverage were occluded. We follow these
cases with angiography until the aneurysm occludes. For this study, we will
select 10 consecutive cases with incomplete aneurysm occlusion and, by the next
angiographic FU, will add a sCTA to the standard DSA.
Study objective
Primary objective:
-To determine the accuracy of sCTA compared to DSA in the visualisation of the
degree of occlusion in the FU of intracranial aneurysms treated with Surpass.
Secondary objectives:
-To determine the accuracy of sCTA compared to DSA in the visualisation of the
patency of parent vessels, and the correct deployment, position and apposition
of the Surpass.
-To assess the complications related to the two diagnostic methods.
Study design
Single centre, retrospective selected case series.
Study burden and risks
Patients will undergo a sCTA in addition to the standard follow-up DSA. This
will not lead to a longer admission, as we will schedule both studies on the
same day. This may mean that a patient has to stay in the hospital for a
slightly longer time (approximately 1 hour). As sCTA is a non-invasive
technique, with side-effects that only very rarely arise as a result of the
administration of the contrast agent, any additional risks are estimated to be
nearly zero.
An extra 50cc of contrast agent will be administered in addition to the
standard care DSA. Patients at risk of contrast-induced nephropathy will be
excluded from participation. Adverse reactions related to the use of the
contrast agent (Xenetix) are generally mild to moderate, and transient. The
adverse reactions most commonly reported are feeling of warmth, pain and oedema
at the injection site. The hypersensitivity reactions are usually immediate
(during the injection or over the hour following the start of the injection) or
sometimes delayed (one hour to several days after the injection).
The total amount of extra radiation that patients will receive at each sCTA is
2.6 mSv.
Geert Grooteplein-Zuid 10
Nijmegen 6500HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
adults (age: 18 to 80) with an unruptured intracranial aneurysm treated with Surpass.
Exclusion criteria
subarachnoid hemorrhage, earlier coiled aneurysm, allergy (hypersensitivity to iobitridol, history of major immediate or delayed skin reaction to Iobitridol injection) or contraindication to contrast agent (manifest thyrotoxicosis, recent treatment with intravenous interleukin 2), use of nephrotoxic medicines (aminoglycosides, organoplatinum compounds, high doses of methotrexate, pentamidine, foscarnet, aciclovir, ganciclovir, valaciclovir, adefovir, cidofovir, tenofovir, vancomycin, amphotericin B, immunosuppressants such as ciclosporine or tacrolimus, ifosfamide), contraindication to CT scan, renal insufficiency, pregnancy, and age <18 years.
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 | NL54067.091.15 |