Validation of Angiography-based FFR as Compared to Pressure Wire-based FFR to Guide Revascularization of Intermediate Coronary Lesions in Non-culprit Vessels in Patients Presenting With ST-segment Elevation Myocardial Infarction
Sponsor study identifier
observational
111
2 countries
2
Study Start
June 22, 2022
Actual (reported)Primary Completion
June 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This prospective multicenter observational cohort study is designed to study the diagnostic performance of acute-setting angiography-based FFR (e.g. vFFR) for the physiological assessment of intermediate non-culprit lesions in STEMI patients, with acute-setting FFR and acute-setting NHPR (e.g. RFR) as the reference standards.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 22, 2022
Actual (reported)January 16, 2023
Actual (reported)January 26, 2023
Actual (reported)June 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting FFR as the reference standard.
Diagnostic performance: sensitivity, specificity, diagnostic accuracy, positive predictive value and negative predictive value (ischemic cutoff value acute-setting vFFR and acute-setting FFR: ≤0.80).
Intraprocedural (0 days)
The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting RFR as the reference standard.
Intraprocedural (0 days)
The diagnostic performance of acute-setting RFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting FFR as the reference standard.
vFFR, FFR, RFR, dPR, CFR and IMR
STEMI patients with multivessel disease undergoing primary percutaneous coronary intervention.
Erasmus University Medical Center
Rotterdam, 3015GD, Netherlands
Medical University of Warsaw
Warsaw, Poland
van der Eijk JA, Groenland FTW, Scoccia A, Ziedses des Plantes AC, Huang J, Nuis RJ, Wilschut JM, den Dekker WK, Diletti R, Kardys I, Tomaniak M, Van Mieghem NM, Daemen J. Validation of angiography-based FFR in non-culprit vessels of patients presenting with STEMI. Clin Res Cardiol. 2025 Sep 8. doi: 10.1007/s00392-025-02729-x. Online ahead of print.
Joost Daemen, MD PhD
Erasmus Medical Center
First Submitted
January 16, 2023
First Posted
January 26, 2023
Study Start
June 22, 2022
Actual (reported)Primary Completion
June 22, 2023
Estimated (date passed)Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound
Intraprocedural (0 days)
The diagnostic performance of acute-setting vFFR for the physiological assessment of intermediate non-culprit lesions, with offline dPR as the reference standard.
Postprocedural (max. 7 days)
The diagnostic performance of offline vFFR for the physiological assessment of intermediate non-culprit lesions, with acute-setting FFR and RFR as the reference standards.
Postprocedural (max. 7 days)
The diagnostic performance of offline vFFR for the physiological assessment of intermediate non-culprit lesions, with offline dPR as the reference standard.
Postprocedural (max. 7 days)
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 26, 2023
Record last verified: 2023-01
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