NCT01153555|Completed
Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy
FIRST
Loading search results
FIRST
Sponsor study identifier
observational
350
1 country
1
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)This is a multi-center, prospective registry of patients with intermediate coronary lesions defined as a stenosis of 40-80% by angiography. Approximately 300 patients will be enrolled into the study at sites in the United States and Europe. There will be no follow up beyond hospital discharge in this study. A sub-group of 30 patients will undergo Adenosine MRI. The investigators hypothesize that Intravascular Ultrasound Radiofrequency (IVUS RF) anatomical criteria, such as minimal luminal area, plaque burden and virtual histology plaque type, can predict physiological ischemia by Fractional Flow Reserve (FFR).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 28, 2010
Actual (reported)June 30, 2010
Actual (reported)September 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 2012
Actual (reported)June 2012
Actual (reported)Correlation between (Minimum Luminal Area) MLA and FFR
The correlation between MLA and FFR; and the threshold value for MLA corresponding to an FFR \< 0.8.
Day of Procedure
Correlation between FFR and IVUS and VH parameters
Day of Procedure
Association of FFR and Cut-off of MLA
Day of Procedure
Identify risk score model
1 year
Diagnostic device: FFR Diagnostic device: IVUS RF At participating centers, FFR and IVUS are standard of care diagnostic procedures for patients with intermediate (40-80% angiographic stenosis by visual estimate). Both modalities were used regularly for such patients whether or not they are participants in this clinical study. In FIRST, the decision to perform percutaneous coronary intervention (PCI) was left to the discretion of the investigator, and was not dictated by the clinical protocol.
Patients required to have an intermediate coronary lesion (stenosis 40-80% by visual estimate) in one or more native, major epicardial coronary artery with reference diameter ≥2.5mm (visual estimate)
Washingtoon Hospital Center
Washington D.C., District of Columbia, 20010, United States
Waksman R, Legutko J, Singh J, Orlando Q, Marso S, Schloss T, Tugaoen J, DeVries J, Palmer N, Haude M, Swymelar S, Torguson R. FIRST: Fractional Flow Reserve and Intravascular Ultrasound Relationship Study. J Am Coll Cardiol. 2013 Mar 5;61(9):917-23. doi: 10.1016/j.jacc.2012.12.012. Epub 2013 Jan 23.
Ron Waksman, MD
Medstar Health Research Institute
350 participants (actual enrollment reported by the registry).
First Submitted
June 28, 2010
First Posted
June 30, 2010
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)Last Updated
March 4, 2015
Record last verified: 2015-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: