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

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03052803
• Collaborator: Acist Medical Systems (Industry), Abbott Medical Devices (Industry), Boston Scientific Corporation (Industry)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Stenosis; Myocardial Ischemia	Device: Fractional flow reserve measure

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)
• Actual Study Start Date: Feb 1, 2017
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Outcome Measures

Primary Outcome Measures

1. Simultaneous FFR measure SJM and ACIST [Immediately]

   Correlation between simultaneous measures with St Jude medical FFR device and ACIST device

2. Simultaneous FFR measure Boston Scientific and ACIST [Immediately]

   Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device

3. Simultaneous FFR measure Boston Scientific and SJM [Immediately]

   Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device

Secondary Outcome Measures

1. FFR SJM or Boston alone versus simultaneous with ACIST [Immediately]

   Correlation between SJM and Boston Scientific FFR measurements alone and simultaneous measure with ACIST

2. Clinical concordance [Immediately]

   Concordance between FFR values >0.80 or <=0.80

3. Drift of the signal [immediately]

   variation between the initial measure in the aorta (equalization) and final measure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CAEN University Hospital	Caen		France

Sponsors and Collaborators

• University Hospital, Caen
• Acist Medical Systems
• Abbott Medical Devices
• Boston Scientific Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT03052803
• Other Study ID Numbers: 16-145
• First Posted: Feb 14, 2017
• Last Update Posted: Jan 25, 2018
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University Hospital, Caen: coronary stenosis; fractional flow reserve
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Stenosis; Ischemia

Study Results

No Results Posted as of Jan 25, 2018