The main objective of this study is to explore the accuracy of sCTA and ceMRA compared to DSA in the diagnosis of complete aneurysm occlusion in patients treated with a FD stent. In addition, we will look at accuracy of sCTA and ceMRA in…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the number of false negative findings for aneurysm
occlusion as measured by sCTA and ceMRA according to modified Raymond-Roy
classification.
Secondary outcome
The secondary study endpoints include positive and negative predictive value,
sensitivity, specificity for complete aneurysm occlusion; degree of aneurysm
occlusion, parent artery patency, device deployment, wall apposition and neck
coverage as measured by sCTA and ceMRA; complications related to diagnostic
methods and interreader agreement for all the imaging techniques.
Background summary
Flow diversion (FD) is a relatively new endovascular treatment strategy which
focuses on parent vessel reconstruction and occlusion of the aneurysm. Digital
subtraction angiography (DSA) is considered the gold standard for the
evaluation of the degree of aneurysms occlusion in treated patients. However,
this diagnostic method is invasive with a risk of thromboembolic and contrast
media associated complications. In addition, it does not depict the
surroundings of the aneurysm. There are some case series on non-invasive
diagnostic methods such as subtraction computed tomography angiography (sCTA)
and contrast enhanced magnetic resonance angiography (ceMRA), though the
reliability of sCTA or ceMRA is not known.
Recently, a pilot study was conducted in our centre to explore the diagnostic
accuracy and safety of sCTA after FD treatment in non-occluded aneurysms in
comparison with DSA. Preliminary pilot data of this study are promising
however sCTA requires validation as follow-up modality as diagnostic tool. In
addition, various studies report the use of ceMRA as follow-up imaging
modality.
Study objective
The main objective of this study is to explore the accuracy of sCTA and ceMRA
compared to DSA in the diagnosis of complete aneurysm occlusion in patients
treated with a FD stent. In addition, we will look at accuracy of sCTA and
ceMRA in visualisation of aneurysm occlusion grade, parent vessel patency and
the position of a FD stent, and we will assess the safety of both methods.
Study design
Single centre prospective cohort study, patients will be enrolled on
consecutive basis.
Study burden and risks
Patients will undergo additional sCTA next to DSA and ceMRA or additional sCTA
and ceMRA next to DSA. We will attempt to combine DSA, ceMRA and sCTA on the
same day. The contrast used for sCTA is the same as for DSA and rarely related
to adverse reactions. We will not include patients at risk of contrast-induced
nephropathy and patients who have recently undergone liver transplantation in
this study. The total amount of additional radiation due to participation will
be 2,4 mSv.
Geert Groteplein Zuid 10
Nijmegen 6525GA
NL
Geert Groteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
aneurysm treated with a flow diverter; 18 years or older
Exclusion criteria
known contra-indications to ceMRA, sCTA or DSA, renal insufficiency
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68375.091.18 |
| OMON | NL-OMON24710 |