Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries

Coronary Artery Disease Clinical Trial

— FFR-DS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052803
• Other study ID #: 16-145
• Status: Completed
• Phase: N/A
• First received: February 10, 2017
• Last updated: January 24, 2018
• Start date: February 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: December 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Fractional flow reserve measure
Comparison of different devices measuring fractional flow reserve

Locations

Country	Name	City	State
France	CAEN University Hospital	Caen

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Caen	Acist Medical Systems, Boston Scientific Corporation, St. Jude Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simultaneous FFR measure SJM and ACIST	Correlation between simultaneous measures with St Jude medical FFR device and ACIST device	Immediately
Primary	Simultaneous FFR measure Boston Scientific and ACIST	Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device	Immediately
Primary	Simultaneous FFR measure Boston Scientific and SJM	Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device	Immediately
Secondary	FFR SJM or Boston alone versus simultaneous with ACIST	Correlation between SJM and Boston Scientific FFR measurements alone and simultaneous measure with ACIST	Immediately
Secondary	Clinical concordance	Concordance between FFR values >0.80 or <=0.80	Immediately
Secondary	Drift of the signal	variation between the initial measure in the aorta (equalization) and final measure	immediately