Ignite Creation Date:
2024-05-06 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05325112
Status:
TERMINATED
Last Update Posted:
2023-01-19
First Post:
2022-04-05
Brief Title:
Assessing Diagnostic Value of Non-invasive FFR-CT Fractional Flow Reserve - Computed Tomography in Coronary Care in the Emergency Department
Sponsor:
HeartFlow Inc
Organization:
HeartFlow Inc
Study Overview
Official Title:
ADVANCE-ED Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency Department
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision to terminate the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADVANCE-ED
Brief Summary:
This is a prospective multi-center study All clinically stable symptomatic patients who present to the emergency department ED or observation unit with suspected coronary artery disease CAD and who have at least one 40 lesion and no lesion 90 confirmed by CCTA Coronary Computed Tomography Angiogram are eligible for enrollment once their CCTA has been completed and their FFR-CT if applicable has been ordered All enrolling sites will have CCTA incorporated into their standard evaluation of chest pain in the EDobservation unit Non-control sites will have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the EDobservation unit
Detailed Description:
This is a prospective multi-center study All clinically stable symptomatic patients who present to the ED or observation unit with suspected CAD and who have at least one 40 lesion and no lesions 90 lesion in a major vessel confirmed by CCTA are eligible for enrollment once their CCTA has been completed and FFR-CT if applicable has been ordered All enrolling sites will have CCTA incorporated into their standard evaluation of chest pain in the EDobservation unit Non-control sites will have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the EDobservation unit
All participating sites will provide demographics medical history CCTA images FFR-CT for non-control sites the decision plan post CCTA and pre FFR-CT for non-control sites length of stay for patients in the EDobservation unithospital billing reports UB-04 preferred 30-day clinical outcomes and any other hospital or office visits imaging andor procedural data completed prior to the follow-up 30-day visit Sites which do not have FFR-CT incorporated into the EDobservation unit will be control sites
All participating sites will provide demographics medical history CCTA images FFR-CT for non-control sites the decision plan post CCTA and pre FFR-CT for non-control sites length of stay for patients in the EDobservation unithospital billing reports UB-04 preferred 30-day clinical outcomes and any other hospital or office visits imaging andor procedural data completed prior to the follow-up 30-day visit Sites which do not have FFR-CT incorporated into the EDobservation unit will be control sites
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