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Recruiting
NCT05698719
Validation of vFFR as Compared to FFR to Guide Revascularization of Non-culprit Lesions in STEMI Patients
Conditions: ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease, Percutaneous Coronary Intervention
Sex: All
Ages: 18 Years – N/A
Enrollment: 111
Sponsor: Erasmus Medical Center
Location: Netherlands
Summary
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.
Eligibility Criteria
Inclusion Criteria:18 years or older.At least one intermediate non-culprit lesion (50-90% diameter stenosis by visual estimation or online QCA) in a non-infarct related artery (reference vessel diameter >2.00 mm) for which invasive pressure wire-based physiological assessment is deemed feasible and indicated.Exclusion Criteria:Presentation with cardiac arrest or cardiogenic shock.Previous coronary artery bypass graft surgery or percutaneous coronary intervention involving the non-culprit vessel.Ostial left main or ostial right coronary artery lesion.Excessive overlap, foreshortening or tortuosity precluding vFFR computation.
Source: ClinicalTrials.gov (NCT05698719). StuddyBuddy aggregates publicly available trial information.