MedTrace Logo

Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Trial

NCT03729739 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2001

Last updated 2024-07-24

No results posted yet for this study

Summary

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.

Conditions

Interventions

DIAGNOSTIC_TEST

QFR-based diagnostic strategy

Novel computer based calculation of lesion severity. Pressure wire-free and adenosine-free

DIAGNOSTIC_TEST

FFR-based diagnostic strategy

Standard FFR based diagnostic method. Pressure drop across the stenosis is measured with a pressure wire during medical induced hyperaemic conditions

Sponsors & Collaborators

  • Medis Medical Imaging Systems

    collaborator UNKNOWN

  • Aarhus University Hospital Skejby

    lead OTHER

Principal Investigators

  • Evald H. Christiansen, Prof. · Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2023-07-21
Completion
2025-12-31

Countries

  • Denmark
  • France
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729739 on ClinicalTrials.gov