Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172985
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-08-17
Brief Title:
A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease
Sponsor:
Keya Medical
Organization:
Keya Medical
Study Overview
Official Title:
A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease a Retrospective Multi-center Blind-evaluation Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trail is to evaluate the effectiveness and accuracy of the CCTA image assisted triage softwareDeepVessel Cardisight Keya Medical for the triage of patients with suspected coronary artery disease
Detailed Description:
The CCTA images collected by each center within a certain period of time would be screened desensitized and then evaluated by the software and independent expert group respectively to evaluate the effectiveness and accuracy of the coronary CT angiography image stenosis assisted triage software developed by Koyal Medical Technology Co
Experiment group Evaluated by the software Independent expert group Evaluated by experts 5 years of CCTA experience required
Experiment group Evaluated by the software Independent expert group Evaluated by experts 5 years of CCTA experience required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None