Real-world performance evaluation of PreSize Neurovascular medical software in a clinical setting
| ISRCTN | ISRCTN17947655 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17947655 |
| IRAS number | 296470 |
| Secondary identifying numbers | CPMS 50137, IRAS 296470 |
- Submission date
- 28/01/2022
- Registration date
- 12/05/2022
- Last edited
- 06/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Stenting is a common treatment for cardiovascular (heart) diseases, such as aneurysms. Stents are small spring-like metallic structures used to strengthen weak blood vessels or open them up when they become clogged. The shape and size of each blood vessel is different so there are many different stents for the doctor to choose from.
The success of the stenting procedure depends on the right fit of the stent in the affected blood vessel. Currently, it is difficult for doctors to predict which stent will give a good fit from looking at the standard brain scans. A company called Oxford Heartbeat has built a computer software (a computer program) called PreSize Neurovascular that can be used by doctors to plan the procedure and help them choose the ‘best fit’ stent for each patient by creating an accurate 3D image of their blood vessels in the brain.
PreSize Neurovascular software has demonstrated high accuracy in calculating the size of the required stent based on patients’ brain scans.
This study tries to understand the benefits of this computer program when used by doctors to help them plan for brain stenting surgeries and how well it works in real-world clinical practice.
Oxford Heartbeat will work with hospitals in England and Scotland to collect this information over a period of about 16 months from approximately 100 patients.
Who can participate?
Patients aged 18 years and above who are scheduled to receive treatment for an intracranial aneurysm with one of the flow diverters compatible with PreSize Neurovascular at one of the participating NHS sites.
What does the study involve?
In this study, the patient will not be asked to do anything that is not already part of their usual treatment. The doctor will plan the stenting procedure using their standard method, and then by using the PreSize Neurovascular computer program. The program will prepare a computer model of the patient’s blood vessels in the brain based on the scans done in preparation for the procedure. The doctor will practice fitting different stents on the computer model. Once both planning methods are complete your doctor will decide at their own discretion which stent to use based on either the standard method or the computer program method. After the procedure, the patient will continue to receive the usual treatment as prescribed by the doctor. If the patient agrees to participate, the study doctor and nurses will collect information about their medical care for study analysis, but no information that could identify the patient (e.g., name, NHS number).
What are the possible benefits and risks of participating?
Patients may not benefit directly from participating in this study. With the help of this study, however, the aim is to gain further insights into how future patient outcomes could be improved and NHS costs reduced through the use of the computer software.
Where is the study run from?
There are participating hospitals across the UK (England, Wales and Scotland). The trial is run from Imperial College Trials Unit and Oxford Heartbeat, the company that developed the software, both based in London, UK.
When is the study starting and how long is it expected to run for?
June 2020 to July 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Investigators and NHS Trusts wishing to express interest in participating in this study please contact presize@imperial.ac.uk
Patients who would like to get more information on participation in the study please contact Chief Investigator Dr Tufail Patankar (tufail.patankar@nhs.net)
Contact information
Scientific
Base KX, 103c Camley St
London
N1C 4PF
United Kingdom
 ORCID ID |
0000-0001-6654-0200 |
|---|---|
| Phone | +44 (0)20 3108 7553 |
| contact@oxfordheartbeat.com |
Public
Clinical Trial Monitor
Imperial Clinical Trials Unit (ICTU)
School of Public Health
Imperial College London
1st Floor, Stadium House
68 Wood Lane
London
W12 7RH
United Kingdom
| Phone | +44 (0)20 7594 0995 |
|---|---|
| presize@imperial.ac.uk |
Study information
| Study design | Non-randomized; Interventional; Design type: Treatment, Process of Care, Device, Imaging, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact the R&D office of a participating hospital to request one |
| Scientific title | Real-world performance evaluation of PreSize Neurovascular medical software in a clinical setting |
| Study acronym | PreSize Neurovascular |
| Study hypothesis | PreSize Neurovascular is accurate at simulating stent length when the software is used under real-world conditions and contributes to improved clinical care by increasing surgical efficiency (e.g. by minimising device waste or reducing procedure and planning time). |
| Ethics approval(s) | Approved 22/08/2021, North of Scotland Research Ethics Service (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458; gram.nosres@nhs.scot), REC ref: 21/NS/0104 |
| Condition | Intracranial aneurysm |
| Intervention | 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 procedures on prospectively identified participants using two methods: first using their usual methods, and then using PreSize Neurovascular software. The brain stenting procedures will be conducted as they usually would be but informed by the planning conducted using PreSize Neurovascular. Study participants will be followed-up after 6 months (as well as after 1 year, where possible considering duration of the whole study). The study will also involve the collection of data on historical cases performed by the participating INRs as a benchmark for the outcomes collected during this study, as well as assessment of INRs feedback regarding the use of software. The feedback will be collected using the survey and 1-2 interviews with each INR. Sample size: 100 participants Cohort: patients undergoing treatment of an intracranial aneurysm with one of the FDs compatible with PreSize Neurovascular software. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/06/2020 |
| Overall study end date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/05/2022 |
| Recruitment end date | 31/07/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Leeds
LS1 3EX
United Kingdom
117 Suttons Lane
Hornchurch
RM12 6RS
United Kingdom
Fulwood
Preston
PR2 9HT
United Kingdom
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
London
WC1N 3BG
United Kingdom
Fazakerley
Liverpool
L9 7LJ
United Kingdom
Glasgow
G51 4TF
United Kingdom
Romford
RM7 0AG
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Sponsor information
Industry
Base KX, 103c Camley St
King's Cross
London
N1C 4PF
England
United Kingdom
| Phone | +44 (0)20 3108 6210 |
|---|---|
| contact@oxfordheartbeat.com |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results of the study will also be disseminated via paper submissions to relevant peer-reviewed journals and conferences. The results are intended to be published within 1 year after the study completion. Plain English results and outcomes will also be disseminated in relevant media, in collaboration with Patient and Public Initiative groups. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/09/2024: The following changes were made to the study record:
1. The recruitment end date has been changed from 30/06/2024 to 31/07/2024.
2. The study participating centres were updated to remove Southampton General Hospital, Addenbrookes, and University Hospital Birmingham, and to add Romford Queens Hospital and Cardiff & Vale University Health Board.
17/06/2024: The following changes were made to the study record:
1. The recruitment end date has been changed from 31/12/2023 to 30/06/2024.
2. The overall study end date has been changed from 31/01/2024 to 31/07/2025.
3. The intention to publish date was changed from 30/06/2024 to 31/07/2025.
4. Contact details updated.
12/06/2023: The following changes have been made and the plain English summary updated accordingly:
1. An acronym was added.
2. The recruitment end date has been changed from 31/12/2022 to 31/12/2023.
3. The overall study end date has been changed from 30/06/2023 to 31/01/2024.
28/01/2022: Trial's existence confirmed by the NIHR.
