Ignite Creation Date:
2024-05-06 @ 7:15 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02499679
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2015-07-13
Brief Title:
Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care
Sponsor:
HeartFlow Inc
Organization:
HeartFlow Inc
Study Overview
Official Title:
Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE ADVANCE
Status:
COMPLETED
Status Verified Date:
2019-08
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:
ADVANCE
Brief Summary:
The objective of the HeartFlow ADVANCE Registry is to evaluate utility clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable symptomatic patients with coronary artery disease CAD in order to further inform patients health care providers and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD
Detailed Description:
REGISTRY OBJECTIVE
The objective of the HeartFlow ADVANCE Registry is to evaluate utility clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable symptomatic patients with CAD in order to further inform patients health care providers and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD
SPECIFIC OBJECTIVES
1 To determine if the availability of FFRCT in addition to coronary anatomy from the cCTA will lead to a significant change in the coronary management plan
2 To assess the real world outcomes of utilizing FFRCT to guide invasive management andor medical treatment
3 To assess resource utilization following standard practice for diagnostic and treatment pathways incorporating FFRCT as the preferred CAD diagnostic test
4 To provide society including patients health care providers and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with CAD
The objective of the HeartFlow ADVANCE Registry is to evaluate utility clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable symptomatic patients with CAD in order to further inform patients health care providers and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD
SPECIFIC OBJECTIVES
1 To determine if the availability of FFRCT in addition to coronary anatomy from the cCTA will lead to a significant change in the coronary management plan
2 To assess the real world outcomes of utilizing FFRCT to guide invasive management andor medical treatment
3 To assess resource utilization following standard practice for diagnostic and treatment pathways incorporating FFRCT as the preferred CAD diagnostic test
4 To provide society including patients health care providers and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with CAD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None