ISRCTN17947655
Active, not recruiting
未知
Real-world performance evaluation of PreSize Neurovascular medical software in a clinical setting
Oxford Heartbeat Ltd0 sites100 target enrollmentMay 12, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Intracranial aneurysm
- Sponsor
- Oxford Heartbeat Ltd
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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