The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses

A Prospective, Observational, Non-randomized European, Multi-center Registry Collecting Real Life Information for the Utilization of Instantaneous Wave Free Ratio in Assessing Coronary Stenosis Relevance in the Multi-vessel Disease Patients Population.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02281110

Acronym

DEFINE REAL

Enrollment

500

Registered

2014-11-03

Start date

2014-07-31

Completion date

2015-12-31

Last updated

2016-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

Diagnostic coronary catheterization, Multi-vessel coronary disease, Percutaneous Coronary Intervention, Instantaneous wave free ratio, Fractional flow reserve

Brief summary

The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac catheterization.

Detailed description

The REAL Registry will enroll a maximum of 3,000 patients in approximately 300 sites across multiple European and Middle East countries, where product has received CE approval and is marketed. An average of 10 cases with a maximum of 50 patients will be enrolled per participating site. No follow-up will be performed. The REAL Registry will only collect data during diagnostic angiogram or PCI procedure, when performed.

Interventions

DEVICEiFR/FFR

• The Volcano iFR®-FFR option, which is a measurement modality for the Volcano system that provides the capability to make FFR and instantaneous wave-Free Ratio™ (iFR®) measurements (CE-Marked). iFR® 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. This PIM-FFR is compatible with all Volcano pressure measurement guide wires.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Over 18 year of age * Willing to participate and able to understand, read and sign the informed consent document before the planned procedure * Eligible for coronary angiography and PCI * Coronary artery disease with at least two or more visually assessed coronary stenoses (greater than 40% diameter stenosis) in native, major epicardial vessel or its branches by coronary angiogram with an indication of physiological assessment.

Exclusion criteria

* Inability to obtain a signed informed consent from potential patient. * Any contraindication for functional assessment as per the instructions per use and determined by the investigator.

Design outcomes

Primary

Measure	Time frame	Description
Hemodynamic severity (Percentage of stenosis properly classified by iFR®)	Day 1 (Post-Procedure)	Percentage of stenosis properly classified by iFR® in terms of hemodynamic severity compare to FFR in MVD patients. Hemodynamic severity will be established with an FFR value \<=0,80.

Secondary

Measure	Time frame	Description
changes in iFR® and FFR	Day 1 (Post-Procedure)	Changes in iFR® and FFR pre angioplasty and post angioplasty in MVD patients.
Changes to decision strategy of revascularization	Day 1 (Post-Procedure)	Percentage of MVD patients in whom the decision strategy of revascularization changed after iFR® compare to the decision based on diagnostic angiogram only.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026