Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries (FFR-DS)

Caen University Hospital

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Stenosis

Treatments: Device: Fractional flow reserve measure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03052803

16-145

Details and patient eligibility

About

The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients hospitalized at Caen University Hospital for coronary angiography
• Coronary stenosis needing FFR evaluation according to recommendations
• More than 18 years old
• Clinically stable
• De novo coronary stenosis
• Affiliated to social security
• Informed consent signed

Exclusion criteria

• Unstable patients defined by acute coronary syndrome < 7 days
• Contre-indication to adenosine administration (asthma, allergy, high grade atrio-ventricular bloc without pace maker)
• History of coronary artery bypass
• intra-stent restenosis
• Patient not capable of understanding the study
• Informed consent not signed