Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-12 @ 5:45 AM
Study NCT ID:
NCT03052803
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2017-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries
Sponsor:
University Hospital, Caen
Organization:
Study Overview
Official Title:
Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)
Status:
COMPLETED
Status Verified Date:
2017-12
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:
FFR-DS
Brief Summary:
The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.
Detailed Description:
The decision to perform a percutaneous coronary intervention (PCI) is usually based on angiographic results alone. Angiography can be used for the visual evaluation of the inner diameter of a vessel. Visual evaluation is limited by inter-individual variability.
Fractional flow reserve provides a functional evaluation, by measuring the pressure decline caused by a vessel narrowing.
The original studies validating the use of FFR were conducted with only one device (St-Jude Medical®). Recently, new FFR devices have been commercialized but have not yet been compared.
Fractional flow reserve provides a functional evaluation, by measuring the pressure decline caused by a vessel narrowing.
The original studies validating the use of FFR were conducted with only one device (St-Jude Medical®). Recently, new FFR devices have been commercialized but have not yet been compared.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: