Intracranial aneurysm Circulatory System
Conditions
Interventions
Study design: Post-market, multi-centre, prospective, non-randomised study
Summary of the study procedures:
Study interventional neuroradiologists (INRs) will plan flow diverter (FD) brain stenting p
Sponsors
Oxford Heartbeat Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 150 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or above 2. Indicated to receive treatment for an intracranial aneurysm with one of the FDs compatible with PreSize Neurovascular at one of the participating NHS sites 3. 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
Exclusion criteria
Exclusion criteria: 1. 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 2. Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. PreSize Neurovascular accuracy at simulating stent length when the software is used in real clinical practice. Accuracy will be assessed by comparing the simulated deployed stent length estimated by PreSize Neurovascular software using pre-operative imaging and the observed deployed stent length from post-operative imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Discrepancy in stent devices (make, length, diameter) selected when at the pre-operative planning stage INRs use traditional planning methods versus when they use PreSize Neurovascular 2. INR satisfaction with the software measured using post-procedural short periodic surveys and qualitative interviews with each INR 3. Planning duration when INRs use traditional planning methods versus when they use PreSize Neurovascular software. The planning duration for the two approaches will be recorded in real-time at the pre-operative stage. 4. Procedure duration and radiation dose during the procedure in cases planned with PreSize Neurovascular. Duration will be measured by timestamps in intra-operative imaging and radiation dose will be recorded post-procedure. The same measures will be collected from historical data from past procedures. 5. Intra-operative corrections, defined as devices deployed additionally and discarded as well as manual manipulations by INRs due to suboptimal stent fit observed in cases planned using PreSize Neurovascular. The corrections will be recorded post-procedure. The same measures will be collected from historical data from past procedures. | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed