Real-world performance evaluation of PreSize Neurovascular medical software in a clinical setting

Study ID: 50137
Short Title: PreSize Neurovascular: Real-World Evaluation
Organisation: University Hospital Southampton NHS Foundation Trust
Location: Southampton General Hospital
Condition: Other
Main Specialty: Neurological disorders
Expected End Date: 27/04/2024
Postcode: SO16 6YD
Contact Name: R&D department
Contact Email: R&
Active: Yes

Inclusion criteria, exclusion criteria and study summary

Participants inclusion criteria: • Adults aged 18 or above, • Indicated to receive treatment for an intracranial aneurysm with one of the FDs compatible with PreSize Neurovascular at one of the participating NHS sites, • Able to receive both pre-operative 3D rotational angiography (3DRA) and post-operative 2D digital subtraction angiography (2DSA) or cone-beam computed tomography (CT), excluding allergy to iodinated contrast media.

Participants exclusion criteria • Any reasons in the opinion of the investigator, e.g. patient cases previously fitted with coiling in the same aneurysmal area might be deemed inappropriate for the purposes of this study if it significantly impacts the contrast in the pre-operative X-ray imaging. • Unable to give informed consent.

Brain aneurysms are bulges in brain arteries, often requiring stenting to prevent their rupture that would result in a stroke. The stenting procedure involves fitting a tiny wire mesh tube inside a diseased artery to give support to artery walls and redirect blood flow to help prevent stroke. Brain stenting procedure is the preferred treatment because it can be delivered by minimally invasive procedure, posing a lower risk than open brain surgery. Though brain stenting is growing in popularity, 4% of patients do not survive and 8-20% need a second procedure (first procedure not having effectively treated the disease), also creating avoidable costs for hospitals/NHS. The main reason for this is because it is difficult for clinicians conducting the procedure (interventional neuroradiologists - INRs) to choose the right stent for each patient. INRs currently rely on X-ray images and their experience to choose the right stent. However, stents are flexible and springy, and it is difficult to accurately imagine how a stent fits when it is placed in an artery. The fit depends on the artery’s shape/size and the stent’s make/size. PreSize Neurovascular software allows clinicians to see in advance, on a computer model developed from the patient’s own scans, how different stents will fit within a patient’s artery so they can choose the best stent for procedure. For this study, 100 patients needing to have certain makes of brain stents fitted will be recruited from at least five hospitals. INRs will plan their procedure first in the usual way and then using PreSize Neurovascular. All other aspects of care will remain as usual except that certain information about their stenting procedure and health 6 months/1 year after the procedure will be analysed to understand how PreSize Neurovascular software may have benefitted them and their clinical team.

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