Ignite Creation Date:
2024-05-05 @ 11:02 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01233518
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2010-10-13
Brief Title:
Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Sponsor:
HeartFlow Inc
Organization:
HeartFlow Inc
Study Overview
Official Title:
Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Status:
COMPLETED
Status Verified Date:
2020-12
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:
DeFACTO
Brief Summary:
This is a prospective multi-center trial conducted at up to 20 US Canadian European and Asian centers designed to determine the diagnostic performance of CT-FLOW the investigational technology by coronary computed tomographic angiography CCTA for non-invasive assessment of the hemodynamic significance of coronary lesions as compared to direct measurement of fractional flow reserve FFR during cardiac catheterization as a reference standard
Detailed Description:
285 patient prospective multi-center trial conducted at up to 20 US Canadian European and Asian centers designed to determine the diagnostic performance of CT-FLOW the investigational technology by coronary computed tomographic angiography CCTA for non-invasive assessment of the hemodynamic significance of coronary lesions as compared to direct measurement of fractional flow reserve FFR during cardiac catheterization as a reference standard
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