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Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Sponsor: Helios Health Institute GmbH
Summary
This is a prospective, randomized, controlled, multicenter, open-label study designed to assess whether vFFR is non-inferior to FFR in assessment of intermediate coronary stenosis in terms of the occurrence of MACE during 12 months after randomization.
Official title: Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1054
Start Date
2020-06-20
Completion Date
2029-11-05
Last Updated
2026-10-29
Healthy Volunteers
No
Interventions
Measurement of FFR
Invasive measurement of fractional flow reserve (FFR) using a pressure wire during maximal hyperemia (typically induced by adenosine) to guide revascularization decisions.
Measurement of vFFR
Computation of vessel fractional flow reserve (vFFR) from coronary angiograms using 3D quantitative coronary angiography (3D-QCA) software to guide revascularization decisions.
Locations (8)
Heart Center Dresden - University Clinic
Dresden, Germany
University Clinic Erlangen
Erlangen, Germany
Universitätsklinikum Essen
Essen, Germany
University Clinic Giessen and Marburg
Giessen, Germany
Herzzentrum Leipzig
Leipzig, Germany
University Clinic Leipzig
Leipzig, Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany
Lukaskrankenhaus Neuss
Neuss, Germany