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

NCT01559493 | Completed

• 1 other identifier: Version F 2nd Jan 2012
• Study Type: observational
• Target: 200
• Locations: 5 countries
• Sites: 5

Brief 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.

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic

Keywords

atherosclerotic lesion assessment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• iFR at rest vs iFr during hyperemia

  30 days

• Repeatability of iFr and FFR

  30 days

Study Arms (1)

FFR; iFR

Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The aim of the present study is to strengthen the results of retrospective comparisons of iFR with FFR by conducting a prospective study in 200 consecutive, unselected patients from 5 different centers.

You may qualify if:

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

You may not qualify if:

• prior CABG
• extremely tortuous, calcified lesions
• coronary artery occlusion
• acute MI within 5 days

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• Golden Jubilee National Hospital: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Onze Lieve Vrouw Hospital: collaborator
• Stockholm South General Hospital: collaborator
• Brno University Hospital: collaborator
• Stanford University: collaborator

Study Sites (5)

Stanford University

Stanford, California, United States

Location

Cardiovascular Center Aalst

Aalst, Belgium

Location

University Hospital Brno

Brno, Czechia

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Stockholm South Hospital

Stockholm, Sweden

Location

Related Publications (1)

• Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.

  PMID: 23395076 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof Keith G. Oldroyd

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

• Prof Colin Berry, MD

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: March 21, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

CZ (1); US (1); NL (1); BE (1); SE (1)