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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01559493
Other study ID # Version F 2nd Jan 2012
Secondary ID
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


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
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