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Clinical Trials/ISRCTN17947655
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.

Registry
who.int
Start Date
May 12, 2022
End Date
July 31, 2025
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Oxford Heartbeat Ltd

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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