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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
2020-10-23
Completion Date
2026-11-01
Last Updated
2024-11-25
Healthy Volunteers
No
Interventions
measurement of FFR
use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses
measurement of Pd/Pa
use of resting distal coronary pressure to aortic pressure ratio (Pd/Pa) to assess the hemodynamic significance of coronary stenoses
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