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

Not Applicable

• Conditions: Intracranial aneurysm; Circulatory System

• Registration Number: ISRCTN17947655
• Lead Sponsor: Oxford Heartbeat Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-12
• Last Update Posted: 9 September 2024
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.