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Completed

NCT Number: NCT02281110

The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Volcano Europe BVBA/SPRL

Zaventem, 1930, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iFR/FFR

Device
  • 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.

Other names: instant flow reserve/fractional flow reserve

Primary outcomes

  1. Hemodynamic severity (Percentage of stenosis properly classified by iFR®)

    Time frame: 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 outcomes

  1. changes in iFR® and FFR

    Time frame: Day 1 (Post-Procedure)

    Changes in iFR® and FFR pre angioplasty and post angioplasty in MVD patients.

  2. Changes to decision strategy of revascularization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Volcano Corporation

Industry

Registry information

Official study title

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.

Acronym: DEFINE REAL

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 3, 2014
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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