Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)

Coronary Artery Disease Clinical Trial

Official title:

Comparison of Fractional Flow Reserve Versus Instant Wave-Free Ratio for Assessment of Coronary Artery Stenosis Severity in Routine Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559493
• Other study ID #: Version F 2nd Jan 2012
• Status: Completed
• Phase: N/A
• First received: February 14, 2012
• Last updated: March 19, 2012
• Start date: January 2012
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: NHS National Waiting Times Centre Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice

• To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI).

• To investigate the influence of hyperemia on iFR.

• To test reproducibility of iFR and FFR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all consecutive patients undergoing FFR assessment for standard clinical indications.

Exclusion Criteria:

• prior CABG

• extremely tortuous, calcified lesions

• coronary artery occlusion

• acute MI within 5 days

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Plaque, Atherosclerotic

Locations

Country	Name	City	State
Belgium	Cardiovascular Center Aalst	Aalst
Czech Republic	University Hospital Brno	Brno
Netherlands	Catharina Ziekenhuis	Eindhoven
Sweden	Stockholm South Hospital	Stockholm
United States	Stanford University	Stanford	California

Sponsors (7)

Lead Sponsor	Collaborator
NHS National Waiting Times Centre Board	Brno University Hospital, Catharina Ziekenhuis Eindhoven, Golden Jubilee National Hospital, Onze Lieve Vrouw Hospital, Stanford University, Stockholm South General Hospital

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice	In this prospective, multicenter, international investigation, all consecutive patients in 5 centers, referred for PCI will be included. FFR will be submitted for one vessel in each patient - this will be the first vessel in which the FFR is performed. Measurements will be performed in duplicate. iFR will be calculated for all lesions for which an FFR measurement is submitted. In addition, iFR and FFR will be compared retrospectively in 1000 patients who had FFR measurements in the recent past	30 days	No
Secondary	iFR at rest vs iFr during hyperemia	iFR is said to be independent of hyperemia. Accordingly a secondary outcome of this study will be a paired comparison of iFR at rest vs iFr with adenosine induced hyperemia.	30 days	No
Secondary	Repeatability of iFr and FFR	To test repeatability of iFR and FFR	30 days	No