NCT03052803

Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries

Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Coronary Stenosis
• Myocardial Ischemia

Interventions

Type	Name	Description
DEVICE	Fractional flow reserve measure	Comparison of different devices measuring fractional flow reserve

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2017-02-14
• Last updated: 2018-01-25

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated device study