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ACTIVE NOT RECRUITING
NCT03497637
NA

Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

Sponsor: Helios Health Institute GmbH

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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