Diagnostic Agreement of iFR and QFR.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-18

Study Completion Date

2018-10-01

Brief Summary

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A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.

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Detailed Description

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During coronary angiography, intermediate stenoses can not be adequately assessed by visual assessment alone. It is necessary to evaluate the functional significance to guide their treatment.

Fractional Flow Reserve (FFR) is the current gold standard for determining this functional significance but its adoption in clinical practice remains low. The instantaneous wave-free ratio (iFR) is an alternative way to determine the flow-limiting characteristics of a coronary stenosis with a pressure wire but without the need to induce hyperemia. Large randomised trials have confirmed the non-inferiority of iFR in respect to FFR in terms of outcome.

Quantitative Flow Ratio (QFR) is another new method for evaluating the functional significance of coronary stenosis It is a software-based analysis of conventional angiographic images to estimate the pressure drop caused by a coronary stenosis. The diagnostic agreement with FFR seemed promising in the FAVOR Pilot Study and a larger trial is enrolling for confirmation.

A stepwise approach of QFR and iFR could make the functional assessment of intermediate stenoses more practical and cost-effective. However before being used as a combination in daily practice, QFR has to be validated in respect to iFR.

The primary objective of the trial is to investigate the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting

Conditions

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Fractional Flow Reserve, Myocardial Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FFR-iFR-QFR group

QFR and iFR

Intervention Type DIAGNOSTIC_TEST

iFR® (CE-Marked) is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option.

QFR® (CE-Marked) is an angio-based FFR estimation using the analytical Software QAngio XA 3D from Medis medical imaging B.V., The Netherland

Interventions

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QFR and iFR

iFR® (CE-Marked) is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option.

QFR® (CE-Marked) is an angio-based FFR estimation using the analytical Software QAngio XA 3D from Medis medical imaging B.V., The Netherland

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing)
* Patients witch semi recent (\>3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction.
* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
* Eligible for coronary angiography and/or percutaneous coronary intervention
* Coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.