Investigate the ability of the intra-operative, intra-aneurysmal flow evaluation to assist with the treatment of intracranial large aneurysms using Embolization Device(s)
The Division of Neuroradiology at UHN (Toronto Western Hospital) would like to initiate a single center registry study on the treatment of large intracranial aneurysms with PIPEline\[tm\] flex embolization devices using optical flow imaging software, "AneurysmFlow". The study team will consent patients diagnosed with unruptured brain / intracratial aneurysms IA(s) . The selected patients ,who booked for elective brain aneurysm repair/endovascular treatment with Flow diverter devices (FDS) called Pipeline embolization devices (PED), will qualify for registry participation . During the PED procedure, the study team will be using AneurysmFlow software to calculate a new metric called the MAFA ratio (Mean Aneurysm Flow Amplitude). By calculating the MAFA ratios intra-operatively, the interventionalist can adapt the therapeutic strategy in order to maximize the flow diverting effect on inducing complete aneurysm occlusions (thrombosis). Additionally, the purpose of this study is to further expand the body of clinical knowledge concerning the relationship between blood flow metrics as determined by the AneurysmFlow software and clinical outcome in patients undergoing treatment for intracranial aneurysms (IAs) with Pipeline and Pipeline Flex embolization devices. The study team aims to collect data at a 12 month follow-up period for each patient
Study Type
OBSERVATIONAL
Enrollment
30
Endovascular treatment of intracranial aneurysms using flow diverting stents
Software to process and display images of intracranial aneurysm treatment using flow diverting stents.
Toronto Western Hospital - University Health Network
Toronto, Ontario, Canada
RECRUITINGNumber of participants with complete aneurysm occlusion at 12 months based on contrast agent volume measurement in angiography.
≥86% complete aneurysm occlusion rate after 12 months post-treatment using optical flow analysis with a MAFA threshold ratio of 0.89, measured with an image processing tool.
Time frame: 1 year
Number of participants with complete aneurysm occlusion at 6 months based on contrast agent volume measurement in angiography.
≥74% complete aneurysm occlusion rate after 6 months post-treatment using optical flow analysis with a MAFA threshold ratio of 0.89, measured with an image processing tool.
Time frame: 6 months
High sensitivity and specificity (> 80%) of the MAFA ratio to determine aneurysm occlusion rates based on ROC statistical calculations.
Data collected from the registry will be used to help determine a new, more optimal MAFA ratio threshold for predicting post-FDS aneurysm occlusion at 12 months post-treatment based on receiver operating characteristic (ROC) statistical curves.
Time frame: 1 year
Number of participants with treatment complications as assessed by an electronic patient record.
Predictability of the MAFA ratio for treatment complications (aneurysm rupture, in-stent thrombosis, mass effect, using a correlation analysis.
Time frame: 1 year
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